Official recall record
CRE™ Wireguided and CRE PRO™ Wireguided Balloon Dilation Catheters
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2026-05-29
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
Boston Scientific is initiating removal of CRE™ Wireguided and CRE PRO™ Wireguided balloon dilation catheters due to a potential sterile breach of the pouches in which the devices are packaged. These catheter products are primarily used to endoscopically dilate strictures of the alimentary tract.
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 2026-06-10.
Record last checked against the registry on 2026-06-10.
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