Official recall record
Cardiohelp-i
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2023-12-04
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
The quality issue under investigation is applicable to the "connection cable venous probe, l0.23m". The part causing the nonconformance under investigation is responsible for data transmission between the Cardiohelp-i and the venous probe. A noticeable high number of breaks in the insulation sheath and a shielding breach of the venous probe connection cable was observed. Recall Start Date: November 21, 2023
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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