Recall Z-1163-2026 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Boston Scientific Corporation
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;
| Date | Feb 5, 2026 (initiated Dec 19, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | 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 organizati |
| Quantity | 588 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, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, JAPAN, Jordan, Kuwait, Lebanon |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K233318 | AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery Syst Boston Scientific Corporation, Oct 27, 2023 |