Official recall record
Autotome RX
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-07-03
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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