Class II — Boston Scientific Corporation
| Recalling firm | Boston Scientific Corporation |
|---|---|
| Registered facility | View this company's 37 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits |
| Quantity | 289 |
| Distribution | Worldwide Distribution - US Distribution to the states of : CA, WI, FL and OH., and to the countries of: Belgium, Czech Republic, Finland, France, Germany, Great Britain, Italy, Spain, Switzerland, Austria, Hungary, Netherlands and Portugal. |
| Initiated | 2015-02-25 |
| Classified | 2015-03-31 |
| Terminated | 2017-06-30 |
| Recall number | Z-1355-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Boston Scientific Corporation (Z-1355-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70604/
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