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 | Foreign material may be present on the enclosed section of the cutting wire which may lead to inability to optimally bow the sphincterotome. This issue may lead to prolongation of procedure. |
| Product | Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct. |
| Quantity | 256 US, 39 OUS |
| Distribution | Domestic distribution nationwide. |
| Initiated | 2024-06-12 |
| Classified | 2024-07-12 |
| Recall number | Z-2350-2024 |
| 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-2350-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94827/
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