Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.
FDA Recall Z-2350-2024 · Posted 2024-07-12
Recalling FirmBoston Scientific Corporation
Recall StatusOpen, Classified
Product CodeKNS
Date Initiated2024-06-12
Product Quantity256 US, 39 OUS
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
Domestic distribution nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.