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…
Read the official notice →- Date
- 2026-02-11
- Country
- United States
- Brand
- Boston Scientific
- Product
- HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;
- Classification
- Class I
- Units
- Worldwide distribution. US Nationwide including Puerto Rico; Algeria,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-05-13
USBoston 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…
- 2026-01-21
- 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…
Other drugs & medical recalls in the United States
- 2026-02-11
- US
VANTIVE US HEALTHCARE LLC recalls PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- US
Olympus Corporation of the Americas recalls Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog…
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
- US
Beckman Coulter, Inc. recalls COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a…
Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.
FDA · DeviceBeckman Coulter, Inc.Worldwide - U.S. Nationwide distribution including in the states of AL, AR,…Official notice → - US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T…
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
- US
HANDELNINE GLOBAL LLC recalls Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India UPC 8 904218 700313
CGMP Deviations: product found to contain lead.
- US