Autotome RX
Brand(s)
Last updated
Summary
Product
Autotome RX
Issue
Medical devices - Sterility Issue
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Autotome RX |
33280747 |
M00545170 |
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology & Urology
Companies
Boston Scientific Corporation
300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75778
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