Boston Scientific recalls
68 official recalls and safety alerts involving Boston Scientific since 2021-12, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Boston Scientific or the relevant agency.
- 2026-09-30
USBoston Scientific Corporation recalls Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/038 BX5; M001314021 IMAGER…
Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism.
FDA · DeviceBoston Scientific CorporationWorldwide - US Nationwide and territories of Puerto Rico and the countries of…Official notice →- 2026-09-23
- US
Boston Scientific Corporation recalls Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1) DVI to…
A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result, the power adaptor may fail electrical safety testing during…
FDA · DeviceBoston Scientific CorporationWorldwide - US Nationwide distribution including in the states of AZ, FL, CA,…Official notice → - 2026-09-09
- US
Boston Scientific Corporation recalls LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Versions…
There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical…
- 2026-08-26
- US
Boston Scientific Corporation recalls Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter
Potential for arterial sheath tip separation or partial tip separation during use.
FDA · DeviceBoston Scientific CorporationWorldwide distribution: US (nationwide) and OUS (foreign) to countries of:…Official notice → - US
Boston Scientific Corporation recalls OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
FDA · DeviceBoston Scientific CorporationWorldwide distribution - US Nationwide and the countries of Austria,…Official notice → - 2026-08-12
- US
Boston Scientific Corporation recalls Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN:…
Potential for breach in sterile barrier of device packaging.
FDA · DeviceBoston Scientific CorporationUS Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA,…Official notice → - 2026-07-29
- US
Boston Scientific Corporation recalls Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.
Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects "Recalculate", the dose…
FDA · DeviceBoston Scientific CorporationUS Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL,…Official notice → - US
Boston Scientific Corporation recalls FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number…
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve…
- US
Boston Scientific Corporation recalls FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
FDA · DeviceBoston Scientific CorporationInternational distribution in the countries of Italy, Austria, France,…Official notice → - US
Boston Scientific Corporation recalls FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
FDA · DeviceBoston Scientific CorporationInternational distribution in the states of Austria, Spain, France, Germany,…Official notice → - 2026-07-22
- US
Boston Scientific Corporation recalls Rapid Refill Continuous Injection System, UPN M00566001
Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete…
FDA · DeviceBoston Scientific CorporationUS Nationwide distribution. OUS consignee list pending.Official notice → - 2026-07-08
- US
Boston Scientific Corporation recalls CRE Pro Wireguided 12-15mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
FDA · DeviceBoston Scientific CorporationWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2026-07-01
- US
Boston Scientific Corporation recalls Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
FDA · DeviceBoston Scientific CorporationUS Nationwide distribution in the state of OH.Official notice → - 2026-06-17
- US
Boston Scientific Corporation recalls Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to be used to…
Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.
- 2026-05-13
- US
Boston Scientific Corporation recalls LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In…
FDA · DeviceBoston Scientific CorporationWorldwide distribution - US Nationwide and the country of Belgium.Official notice → - 2026-05-06
- US
Boston Scientific Corporation recalls Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALITUDE CRT-P EL…
Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding…
- 2026-03-18
- US
Boston Scientific Corporation recalls EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;
Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This…
- 2026-02-11
- US
Boston Scientific Corporation recalls HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new…
FDA · DeviceBoston Scientific CorporationWorldwide distribution. US Nationwide including Puerto Rico; Algeria,…Official notice → - 2026-01-21
- US
Boston Scientific Corporation recalls Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF…
Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation…
FDA · DeviceBoston Scientific CorporationUS Nationwide distribution in the states of MA, WV, OH, CA, MN, NY, VA, IL TX,…Official notice → - 2025-10-22
- US
Boston Scientific Corporation recalls TENACIO Pump without InhibiZone; UPN: 72404420;
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
FDA · DeviceBoston Scientific CorporationWorldwide distribution - US Nationwide and the country of Canada.Official notice → - US
Boston Scientific Corporation recalls Model Number L211 PROPONENT DR SL MRI Pacemaker
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes…
- 2025-10-01
- US
Boston Scientific Corporation recalls Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);
The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.
FDA · DeviceBoston Scientific CorporationUS Nationwide distribution in the states of CA, CO, GA, ID, IL, IN, MA, ME,…Official notice → - 2025-09-17
- US
Boston Scientific Corporation recalls ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02,…
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
FDA · DeviceBoston Scientific CorporationWorldwide - US Nationwide and the countries of Canada, France, Germany and…Official notice → - US
Boston Scientific Corporation recalls Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material…
- 2025-09-10
- US
Boston Scientific Corporation recalls WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal access for…
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in…
- 2025-08-27
- US
Boston Scientific Corporation recalls ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model Nos. 0282,…
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or…
FDA · DeviceBoston Scientific CorporationWorldwide Distribution. US nationwide. International distribution worldwide.Official notice → - 2025-08-20
- US
Boston Scientific Corporation recalls FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.
- US
Boston Scientific Corporation recalls Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system. Material numbers:…
Certain batches are being removed due to an increase in complaints received in which physicians encountered greater than anticipated resistance while attempting to withdraw the stent delivery system (SDS) from the…
FDA · DeviceBoston Scientific CorporationDomestic US Nationwide distribution including Puerto Rico. International…Official notice → - 2025-07-16
- US
Boston Scientific Corporation recalls Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX 8.5F 63CM 55DEG Used…
Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may…
FDA · DeviceBoston Scientific CorporationWorldwide distribution - US Nationwide and the countries of Canada, Hong Kong,…Official notice → - 2025-05-07
- US
Boston Scientific Corporation recalls IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended to convert high-pressure gas to…
Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon…
- 2025-02-05
- US
Boston Scientific Corporation recalls AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
FDA · DeviceBoston Scientific CorporationNationwide including Puerto Rico Foreign: To be providedOfficial notice → - 2025-01-22
- US
Boston Scientific Corporation recalls PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221),…
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to…
FDA · DeviceBoston Scientific CorporationUS (Nationwide) including Puerto Rico and US Virgin Islands and OUS (foreign)…Official notice → - 2024-12-04
- US
Boston Scientific Corporation recalls AMS Artificial Urinary Sphincter Control Pump
Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
FDA · DeviceBoston Scientific CorporationWorldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, KS,…Official notice → - 2024-11-20
- US
Boston Scientific Corporation recalls Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
- 2024-10-30
- US
Boston Scientific Corporation recalls Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac…
Patients using the Model 2939 myLUX Patient Application on their Apple mobile device (e.g., iPhone) may not be transmitting data from their Insertable Cardiac Monitor to the LATITUDE Clarity website.
FDA · DeviceBoston Scientific CorporationNationwide distribution to AL, AZ, CA, CO, FL, GA, ID, KY, MA, MD, NC, NJ, NY,…Official notice → - 2024-10-23
- US
Boston Scientific Corporation recalls Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - ZERO COST US; the system utilizes an…
Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality…
FDA · DeviceBoston Scientific CorporationUS Nationwide distribution in Puerto Rico.Official notice → - 2024-10-02
- US
Boston Scientific Corporation recalls WALLFLEX FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for…
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
FDA · DeviceBoston Scientific CorporationWorldwide distribution - US Nationwide and the countries of APAC, Canada,…Official notice → - 2024-09-25
- US
Boston Scientific Corporation recalls VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the urinary tract.
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
- 2024-08-07
- US
Boston Scientific Corporation recalls Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Package UPN: M0068318260. Capio SLIM Suture…
Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention.
FDA · DeviceBoston Scientific CorporationDomestic: Nationwide Distribution. International: PendingOfficial notice → - 2024-07-24
- US
Boston Scientific Corporation recalls Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation…
Foreign material may be present on the enclosed section of the cutting wire which may lead to inability to optimally bow the sphincterotome. This issue may lead to prolongation of procedure.
- 2024-05-22
- US
Boston Scientific Corporation recalls Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H749085263002; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material…
FDA · DeviceBoston Scientific CorporationWorldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia…Official notice → - 2024-04-17
- US
Boston Scientific Corporation recalls EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and…
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a…
FDA · DeviceBoston Scientific CorporationWorldwide distribution - US Nationwide and the country of Japan.Official notice → - 2024-04-03
- US
Boston Scientific Corporation recalls OptiCross Coronary Imaging Catheter, REF H749518080120
Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.
FDA · DeviceBoston Scientific CorporationInternational distribution to the country of Japan.Official notice → - US
Boston Scientific Corporation recalls Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system
Boston Scientific is conducting a removal of specific batches of the iSLEEVETM 14F Expandable Introducer Set due to complaints associated with a hemostatic valve leak.
FDA · DeviceBoston Scientific CorporationWorldwide distribution - US Nationwide and the countries of Canada.Official notice → - US
Boston Scientific Corporation recalls Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010
An investigation determined that delivery of the Obsidio embolic using the aliquot technique for lower gastrointestinal bleeding embolization poses a high risk of bowel ischemia. The most serious and the most common…
- US
Boston Scientific Corporation recalls Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
Boston Scientific has identified a tooling error in manufacturing which may have caused delamination of the inner lumen of the sheath shaft in a subset of POLARSHEATH devices. This could result in the embolization of a…
FDA · DeviceBoston Scientific CorporationAustria, Belarus, Estonia, Finland, France, Germany, Great Britain, Greece,…Official notice → - 2024-02-28
- US
Boston Scientific Corporation recalls EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.
Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replacement button, but are labeled as being for a 28F. Use of defective product may lead to undersizing the button, which may…
FDA · DeviceBoston Scientific CorporationInternational distribution to the country of Japan only.Official notice → - 2024-01-17
- US
Boston Scientific Corporation recalls Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application…
The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generators will display certain diagnostic dates incorrectly, with a year in the 1990s.
FDA · DeviceBoston Scientific CorporationDistribution was nationwide, including Guam, Puerto Rico, and the U.S. Virgin…Official notice → - 2023-11-29
- US
Boston Scientific Corporation recalls EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.
Poor image quality due to fluid ingress in the lens.
FDA · DeviceBoston Scientific CorporationWorldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice → - 2023-10-11
- US
Boston Scientific Corporation recalls Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M003101630, cardiac guide catheter
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from…
FDA · DeviceBoston Scientific CorporationUS Nationwide distribution in the state of Indiana.Official notice → - 2023-08-30
- US
Boston Scientific Corporation recalls EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator
There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.
- 2023-08-02
- US
Boston Scientific Corporation recalls Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that transmits Ho:YAG laser energy from cleared…
Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the…
FDA · DeviceBoston Scientific CorporationWorldwide distribution - US Nationwide and the country of Canada.Official notice → - 2023-05-24
- US
Boston Scientific Corporation recalls WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)
The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.
- 2023-04-26
- US
Boston Scientific Corporation recalls Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency (RF) catheter which provides bipolar energy to…
Cease use of the Habib EndoHPB Bipolar RF Catheter with the ERBE VIO3 Generator immediately due to the potential for delivery of excessive energy leading to thermal injury or tissue damage. An inaccurate setting is…
FDA · DeviceBoston Scientific CorporationWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - 2023-03-15
- US
Boston Scientific Corporation recalls LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
Under specific circumstances, the U.S. product registration system did not send up enablement requests to U.S. LATITUDE Customer Support during an 8-month interval in 2022. For these patients, the HeartLogic Index and…
FDA · DeviceBoston Scientific CorporationUS Nationwide distribution to the healthcare facilities and healthcare…Official notice → - 2022-11-16
- US
Boston Scientific Corporation recalls ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps,…
***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions*** Potential outcomes associated with foreign body reaction to remnant ORlSE Gel post procedure. Foreign body…
FDA · DeviceBoston Scientific CorporationWorldwide Distribution: US (Nationwide) and (Foreign) countries of: Algeria…Official notice → - 2022-11-09
- US
Boston Scientific Corporation recalls EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
FDA · DeviceBoston Scientific CorporationWorldwide distribution - US Nationwide distribution in the countries of AL,…Official notice → - US
Boston Scientific Corporation recalls EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.
Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
FDA · DeviceBoston Scientific CorporationDistribution was made to CA, IL, KY, OH, OK, RI, TX. There was no…Official notice → - 2022-09-07
- US
Boston Scientific Corporation recalls The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable…
There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous…
- 2022-08-31
- US
Boston Scientific Corporation recalls Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.
FDA · DeviceBoston Scientific CorporationInternational distribution in the countries of Greece, France, Germany, Italy,…Official notice → - 2022-08-10
- US
Boston Scientific Corporation recalls EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components.…
Product may be mislabeled.
FDA · DeviceBoston Scientific CorporationUS distribution only - CA, CT, GA, IA, IL, IN, NY, OH, TX, WYOfficial notice → - 2022-07-27
- US
Boston Scientific Corporation recalls GreenLight HPSEA Laser Fibers, UPN 0010-2092
Several complaints were received for the affected lot; users received a "Fiber type does not match card type" error message on the GreenLight XPS Laser console, necessitating the replacement of the laser fiber and…
FDA · DeviceBoston Scientific CorporationDomestic distribution to AR CA IL ME MI NC TX Foreign distribution to…Official notice → - 2022-05-25
- US
Boston Scientific Corporation recalls EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 Intended Use: sterile, single-use, flexible video duodenoscope…
Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device.
FDA · DeviceBoston Scientific CorporationWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2022-05-04
- US
Boston Scientific Corporation recalls SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away from the…
Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that describe steps to verify correct…
- 2022-04-20
- US
Boston Scientific Corporation recalls ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
Pouch seals may be open, compromising sterility.
FDA · DeviceBoston Scientific CorporationDistribution in the US and territories, Japan, and CanadaOfficial notice → - 2022-03-23
- US
Boston Scientific Corporation recalls HYDRATOME RX 44-20MM/450CM Material Number: M00583060
Sterility of device is compromised due to a sterile barrier breach
FDA · DeviceBoston Scientific CorporationWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2021-12-22
- US
Boston Scientific Corporation recalls Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity.
FDA · DeviceBoston Scientific CorporationWorldwide distribution - US Nationwide distribution in the states of FL, NV,…Official notice → - 2021-12-08
- US
Boston Scientific Corporation recalls HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN:…
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure