FDA DevicesClass I
AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material...
Published: February 11, 2026Recall ID: Z-1158-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;
Affected Products
AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;
Additional Source Details
| Field | Value |
|---|---|
| City | Marlborough |
| State | MA |
| Event id | 98237 |
| Address 1 | 100 Boston Scientific Way |
| Address 2 | N/A |
| Code info | Material Number (UPN): M00553680; UDI-DI: 8714729951179; Lot Numbers: 35961006, , 35961007, , 35962524, , 35967379, , 35968520, 35968521, 35968597, 35968598, 35971077, 35971078, 35971079, 35972100, 35982272, 35982273, 35982274, 35982275, 35982276, 35982277, 35982278, 35982279, 35982420, 35982424, 35982425, 35985313, 35985314, 35993619, 35993720, 35993721, 36109761, 36109763, 36109764, 36109765, 36109766, 36111314, 36111315, 36118993, 36118994, 36122066, 36122067, 36122075, 36132801, 36132802, 36132803, 36132804, 36134972, 36144058, 36144059, 36144120, 36144121, 36174475, 36174476, 36178005, 36187588, 36187589, 36187687, 36187688, 36188887, 36188888, 36188889, 36194446, 36194447, 36197239, 36198580, 36217768, 36217769, 36217770, 36227341, 36227342, 36227343, 36228603, 36228604, 36228605, 36235934, 36236151, 36240589, 36240590, 36241715, 36241716, 36241717, 36251363, 36251364, 36253000, 36253008, 36253041, 36260860, 36260861, 36260862, 36261599, 36261780, 36261781, 36261834, 36261835, 36... [TRUNCATED] |
| Postal code | 01752-1234 |
| Report date | 20260211 |
| Product type | Devices |
| Product quantity | 557 units |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251219 |
| Initial firm notification | N/A |
| Center classification date | 20260205 |
Overview
- Recalling FirmBoston Scientific Corporation
- StatusOngoing
- Risk LevelClass I
- DistributionWorldwide 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, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, PERU, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, UAE, and United Kingdom.