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Health Canada Medical devices

Autotome RX

Issued July 3, 2024
Issue
Boston Scientific is initiating a removal of one lot of Autotome Cannulating Sphincterotomes due to reports of the presence of foreign material on the enclosed section of the cutting wire, between the handle and the distal end of the device which may lead to inability to optimally bow the sphincterotome. Recall Start Date: June 12, 2024
Hazard description
Sterility
Product
Product name
Autotome RX
Reference
ID
RA-75778