Product Wiki · Recalls · Health Canada — Medical Devices

Automated Impella Controller — recall 81652

Health Canada — Medical Devices · Canada · 2026-02-25 · Type I

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Agency
Health Canada — Medical Devices
Recall identifier
81652
Date of alert
2026-02-25
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
Cardiovascular
Product type
Medical devices
Reported risk: Abiomed has identified that Automated Impella Controller (AICS) with software V8.2.3, when used in conjunction with an Impella 5.5 with smart assist set (product code 0550-0004), has a delayed "purge system blocked" alarm. Software versions post-v10.1 have this issue addressed. Abiomed recommends that you do not use the AIC with an Impella 5.5 with smart assist set (product code 0550-0004) unless AIC software is updated to v10.1 or above.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/automated-impella-controller

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