FDA Recall
Open, Classified
Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.
Recall: Z-2350-2024
·
Initiated June 12, 2024
Recall
- Recall Number
- Z-2350-2024
- Event Number
- 94827
- Firm
- Boston Scientific Corporation
- FEI Number
- 3005099803
- Product Code
- KNS
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- June 12, 2024
- Posted
- July 12, 2024
- Address
- 100 Boston Scientific Way, Marlborough, MA, 01752-1234
Description
Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.
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.
Action
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.
Distribution
Domestic distribution nationwide.
Quantity
256 US, 39 OUS