CanadaAbiomed Inc.’s Impella Controller (model/catalogue numbers 0042-0040-CA and 0042-0000-CA) running software versions V6.0.1–6.0.3 and ≥7.1 is affected. Abiomed issued a voluntary device recall to notify customers of a potential software error in the Automated Impella Controller that may force the controller to restart when used with left ventricular Impella devices and could contribute to serious injury or death in certain patient populations; product is not being removed and hospital inventory can continue to be used. Contact the manufacturer for additional information.
What's being recalled
Companies: Abiomed Inc., 22 Cherry Hill Drive, Danvers, Massachusetts, United States, 01923.
How to identify it
Affected products: Impella Controller; Lot or serial number: Software V6.0.1–6.0.3 and ≥7.1; Model or catalogue number: 0042-0040-CA
Affected products: Impella Controller; Lot or serial number: Software V6.0.1–6.0.3 and ≥7.1; Model or catalogue number: 0042-0000-CA
The hazard
Abiomed, Inc. has issued a voluntary device recall (correction) to notify customers of a potential software error in the Automated Impella Controller ("AIC") which may be forced to restart when used in conjunction with left ventricular Impella devices. This potential software error, in a specific clinical circumstance, could contribute to serious injury or death in certain patient populations. Product is not being removed, and hospital inventory can continue to be used.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)