Boston Scientific Advanix Pancreatic Stent — Class II medical device recall Z-0558-2020
Terminated recall by Boston Scientific Corporation, reported 2019-12-04, distributed nationwide. Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf
| Recall number | Z-0558-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2019-10-21 |
| Classified | 2019-11-25 |
| Reported by FDA | 2019-12-04 |
| Terminated | 2023-12-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BG, CH, CZ, DE, DK, ES, FI, FR, GB, HR, IT, JP, PK, PL, SE, SK, TH, TR, ZA |
| Quantity | 66 units |
| Reason classes | labeling |
| Lot numbers | 21750674, 22036150, 22647191, 23902873 |
Product
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 13cm UPN: M00536710
Reason for recall
Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
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-0558-2020. 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.