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…
Read the official notice →- Date
- 2023-08-02
- Country
- United States
- Brand
- Boston Scientific
- Product
- Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that transmits Ho:YAG laser energy from cleared laser…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the country of Canada.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Boston Scientific recalls
- 2023-11-29
USBoston 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.
- 2023-05-24
- 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 →
Other drugs & medical recalls in the United States
- 2023-08-02
- US
Beckman Coulter, Inc. recalls Ringed DxI Reaction Vessels (RVs)
Beckman Coulter, Inc. is recalling Ringed DxI Reaction Vessels (RVs) as part of Unicel DxI Immunoassay System (600, 800 series). The reason for the recall is that the firm has identified 3 lots of RVs that failed an…
FDA · DeviceBeckman Coulter, Inc.Worldwide - US Nationwide distribution in the states of CA, MA, TX, NJ, MI,…Official notice → - US
Trexo Robotics Holdings Inc. recalls Trexo Device
Electrical issues that could potentially render the device non-functional, give off electromagnetic influence to surrounding equipment, and risk of burns when in use.
FDA · DeviceTrexo Robotics Holdings Inc.Worldwide distribution - US Nationwide and the countries of the Argentina,…Official notice → - US
Virtual Radiologic Corp. recalls vRad PACS with Mammography
The error resulted in intermittent failure of current (primary) radiology study images not displaying to the interpreting teleradiologist.
FDA · DeviceVirtual Radiologic Corp.US Nationwide distribution in the states of MD, MN, TN, FL, GA, TX, OK.Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs
The case and each (i.e. packet) labels for the DYND3000xxP series do not include an expiration date, however, the lubricating jelly (MDS032280) included in the DYNDP3000xxP series is labeled with an expiration date.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldWorldwide distribution - US Nationwide and the country of Bermuda.Official notice → - US
Medtronic Neuromodulation recalls A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
When an update to the A710 Clinician Programmer software application for the Intellis Neurostimulation System was released, the corresponding version of the A901 Communication Manager software application was not…
FDA · DeviceMedtronic NeuromodulationInternational distribution to the countries of Israel and Serbia.Official notice → - US
Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the…
May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).
FDA · DeviceOrtho-Clinical Diagnostics, Inc.US Nationwide distribution in the state of CA.Official notice →