AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690;
FDA device recall Z-1160-2026 · posted 2026-02-05 · Open, Classified
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- 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 one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
- Action taken
- On December 19, 2025, Urgent Medical Device Removal - Immediate Action Required letters were sent to customers. Actions to be taken: - Immediately stop further distribution or use of any remaining affected devices. Remove them from your facility s inventory and segregate them in a secure location until they can be returned to Boston Scientific. " Immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device. " Share this notice with any health care professional within your organization and with any organization where the affected products may have been transferred. " If you are a distributor, this notification must be forwarded to your customers to ensure notification of this product removal is carried out to the end-user level. " If you are a facility that has sent products to another hospital or a facility within your network, ensure this notification is forwarded to them. " Boston Scientific reminds healthcare professionals that AXIOS Stents should only be used as indicated in Instructions For Use.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- KNS
- Quantity affected
- 59 units
- Distribution
- Worldwide distribution. US Nationwide including Puerto Rico; Algeria, Argentina, Austria, Belgium, Brazil, Canada, CHILE, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germa
- Date initiated
- 2025-12-19
- Date posted
- 2026-02-05
- Location
- Marlborough, MA
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