Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.
This recall is currently active, issued July 12, 2024. It was issued by Boston Scientific Corporation.
- Company
- Boston Scientific Corporation
- Recall Initiated
- June 12, 2024
- Posted
- July 12, 2024
- Recall Number
- Z-2350-2024
- Quantity
- 256 US, 39 OUS
- Firm Location
- Marlborough, MA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Domestic distribution nationwide.
Lot / Code Info
UDI-DI (GTIN) 08714729444749 Lot 33280747 Expiration Date: January 23, 2027
Root Cause
Process control
Action Taken
All customers notified via courier on June 12, 2024 - notice was titled "Urgent Medical Device Removal." Customers were informed to cease further use or distribution of any remaining affected product. Product should be segregated and returned to the firm. For more information, please reach out to your local Boston Scientific representative.