Class II

Medical Device Recall: Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.

Boston Scientific Corporation · June 12, 2024

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.

States Affected

NATIONWIDE

Quantity Affected

256 US, 39 OUS

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2350-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.