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 | Ongoing |
| Reason | Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel. |
| Product | Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570 |
| Quantity | 458 units |
| Distribution | Distribution US nationwide and Japan. |
| Initiated | 2020-11-16 |
| Classified | 2020-12-30 |
| Recall number | Z-0757-2021 |
| 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-0757-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86880/
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