HOT AXIOS Stent and Electrocautery- Enhanced Delivery System… — Class II medical device recall Z-1037-2025
Ongoing recall by Boston Scientific Corporation, reported 2025-02-05, distributed nationwide. Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventin
| Recall number | Z-1037-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2024-12-20 |
| Classified | 2025-01-30 |
| Reported by FDA | 2025-02-05 |
| Distributed | Nationwide (US) |
| Quantity | 118 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 08714729976684 |
| Lot numbers | 32878539, 33336847, 33338446, 33775901, 33795273, 33900261, 33900262, 34076575, 34083270, 34172108, 34172109 |
Product
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570
Reason for recall
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.
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-1037-2025. 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.