CanadaAutomated Impella Controller (AIC) units running software version 8.2.3 (model/catalogue numbers 0042-0040-CA and 0042-0000-CA) used with an Impella 5.5 with smart assist set (product code 0550-0004) are affected. Abiomed found these AICs can produce a delayed "purge system blocked" alarm. Do not use the AIC with an Impella 5.5 smart assist set unless the AIC software is updated to v10.1 or above, and contact the manufacturer for more information.
What's being recalled
Companies: Abiomed Inc., 22 Cherry Hill Drive, Danvers, Massachusetts, United States, 01923.
How to identify it
Affected products: Automated Impella Controller; Lot or serial number: Software version 8.2.3; Model or catalogue number: 0042-0040-CA
Affected products: Automated Impella Controller; Lot or serial number: Software version 8.2.3; Model or catalogue number: 0042-0000-CA
The hazard
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.
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)