Recall Z-2350-2024 — Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.
U.S. FDA — Device Enforcement · United States · 2024-06-12 · Class II
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Reported risk: 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.
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