AXIOS Stent and Electrocautery — Class II medical device recall Z-0774-2021
Terminated recall by Boston Scientific Corporation, reported 2021-01-13, distributed nationwide. The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of
| Recall number | Z-0774-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2020-12-01 |
| Classified | 2021-01-06 |
| Reported by FDA | 2021-01-13 |
| Terminated | 2023-07-14 |
| Distributed | Nationwide (US) |
| Quantity | 32 units |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 08714729904595 |
| Lot numbers | 26152465, 26152466, 26152467 |
| Expiration dates | 2022-10-08 |
Product
AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm UPN: M00553650 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
Reason for recall
The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or procedure or risk of peritonitis developing from leakage of enteric, pseudocyst, or biliary contents into the peritoneal cavity
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-0774-2021. 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.