*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x… — Class I medical device recall Z-1163-2026
Ongoing recall by Boston Scientific Corporation, reported 2026-02-11, distributed nationwide. Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable res
| Recall number | Z-1163-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2025-12-19 |
| Classified | 2026-02-05 |
| Reported by FDA | 2026-02-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, BE, BR, CA, CH, CL, CO, CR, CZ, DE, DK, DZ, ES, FI, FR, GB, GR, HR, HU, ID, IE, IL, IN, IR, IT, JO, JP, KW, LB, LU, MA, MX, MY, NL, NO, OM, PA, PE, PK, PL, PT, PY, RO, RS, SA, SE, SI, SK, ZA |
| Quantity | 588 units |
| UPC / GTIN / UDI-DI | 08714729951100 |
| Lot numbers | 35793920, 35952745, 35961004, 35995006, 35995007, 35995165, 36001950, 36001951, 36001952, 36001953, 36002902, 36002903, 36002904, 36003946, 36003947, 36003948, 36012845, 36012846, 36012847, 36012848, 36015761, 36021049, 36021050, 36021051, 36021052, 36027054, 36027055, 36027056, 36027057, 36027058, 36027059, 36027060, 36027061, 36038410, 36038411, 36040000, 36040001, 36040002, 36040003, 36040004 and 460 more |
Product
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1163-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.