Official recall record
Penumbra System RED 68 Reperfusion Catheter
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2026-06-22
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
Penumbra has identified an issue in the lots of RED 68 specified in this notification which may result in potential fracture of the device. Penumbra has not received reports of any events involving patient injury related to these fractures; however, fracture of the catheter may result in patient injury or death.
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 2026-07-02.
Record last checked against the registry on 2026-07-02.
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