Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary… — Class II medical device recall Z-1355-2015
Terminated recall by Boston Scientific Corporation, reported 2015-04-08, distributed in CA, FL, OH, WI. Complaints of device fragmentation after the catheter was implanted in the biliary system. The most serious pa
| Recall number | Z-1355-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Maple Grove, MN, United States |
| Recall initiated | 2015-02-25 |
| Classified | 2015-03-31 |
| Reported by FDA | 2015-04-08 |
| Terminated | 2017-06-30 |
| Distributed | CA, FL, OH, WI |
| Countries outside the US | AT, BE, CH, CZ, DE, ES, FI, FR, GB, HU, IT, NL, PT |
| Quantity | 289 |
| UPC / GTIN / UDI-DI | 07493933110350 |
| Lot numbers | 17245003, 17245004, 17245005, 17245006, 17259580, 17275815, 17275819, 17275822, 17275824, 17318047, 17328808, 17338207, 17370709, 17403871, 17408756, 17411333, 17416578, 17416605, 17416608, 17438003, 17459144, 17489192, 17493554, 17494025, 17501572, H7493933108200, H7493933108350, H749393310835K1, H7493933110200, H7493933110350, H749393311035K1, H7493933110400, H7493933112350, H7493933114350 |
Product
Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits
Reason for recall
Complaints of device fragmentation after the catheter was implanted in the biliary system. The most serious patient risk for this issue is additional intervention for fragment retrieval using minimally invasive methods and, in some of the reported cases, this was performed to retrieve the device fragments.
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-1355-2015. 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.