Official recall record
Introducer kits in Impella Pump Set and Axillary Insertion Kit
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2023-12-21
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
There is a potential risk of packaging damage for introducer kits which may compromise the sterile barrier. There have been no reported complaints for this type of damage and this issue was found in <0.6% of all introducer kits that was received. The following introducer kit identifiers, 0052-3006, 0052-3046, 0052-3014, 0052-3025, 0052-3052 which are part of the Impella pump sets and insertion kits are affected by the recall action. Recall Start Date: December 11, 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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