FDA-Device2024-07-24Class II
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
Hazard
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.
Sold states
Domestic distribution nationwide.
Affected count
256 US, 39 OUS
Manufactured in
100 Boston Scientific Way, Marlborough, MA, United States
Products
Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2350-2024Don't want to check this manually?
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