Recall Z-1037-2025 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Boston Scientific Corporation
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570
| Date | Jan 29, 2025 (initiated Dec 20, 2024) |
| Status | Open, Classified |
| Reason | Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one. |
| Root cause | Process control |
| Action | Boston Scientific issued Urgent Medical Device Removal - Immediate Action Required Letter via Fedex Priority Overnight on December 20, 2024 to US consignees. Letter states reason for recall, health risk and action to take: This removal affects only the products listed in Attachment 1. 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 b |
| Quantity | 118 units (OUS) |
| Distribution | Nationwide including Puerto Rico Foreign: To be provided |
| 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 |