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…
Read the official notice →- Date
- 2024-10-23
- Country
- United States
- Brand
- Boston Scientific
- Product
- Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - ZERO COST US; the system utilizes an interactive…
- Classification
- Class II
- Units
- US Nationwide distribution in Puerto Rico.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-12-04
USBoston 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 → - 2024-10-02
- 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 →
Other drugs & medical recalls in the United States
- 2024-10-23
- US
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE KIT CV I II, REF DYNJ906071B
Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly…
- US
Beckman Coulter Inc. recalls IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry…
Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU
FDA · DeviceBeckman Coulter Inc.U.S.: AZ, CA, CO, FL, GA, HI, IL, MA, MI, MO, ND, NY, OH, PA, and TX O.U.S.:…Official notice → - US
Spineology, Inc. recalls The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft material, then advanced through the Access…
Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed by our surgical technique.
- US
Beckman Coulter, Inc. recalls The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human…
Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results.
FDA · DeviceBeckman Coulter, Inc.Worldwide distribution - US Nationwide and the countries of Austria, Belgium,…Official notice → - US
Beckman Coulter, Inc. recalls Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.
Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB negative glucose control failure, resulting in false positive control results when used in conjunction with…
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CUE HEALTH INC recalls Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.