CanadaWhat's being recalled
Companies: Abiomed Inc., 22 Cherry Hill Drive, Danvers, Massachusetts, United States, 01923.
How to identify it
Affected products: Automated Impella® Controllers (AIC); Lot or serial number: IC13503; Model or catalogue number: 0042-0040-CA
Affected products: Automated Impella® Controllers (AIC); Lot or serial number: IC13266; Model or catalogue number: 0042-0040-CA
Affected products: Automated Impella® Controllers (AIC); Lot or serial number: IC11171; Model or catalogue number: 0042-0040-CA
Affected products: Automated Impella® Controllers (AIC); Lot or serial number: IC11172; Model or catalogue number: 0042-0040-CA
Affected products: Automated Impella® Controllers (AIC); Lot or serial number: IC1769; Model or catalogue number: 0042-0000-CA
Affected products: Automated Impella® Controllers (AIC); Lot or serial number: IC5821; Model or catalogue number: 0042-0000-CA
Affected products: Automated Impella® Controllers (AIC); Lot or serial number: IC5824; Model or catalogue number: 0042-0000-CA
Affected products: Automated Impella® Controllers (AIC); Lot or serial number: IC9416; Model or catalogue number: 0042-0000-CA
Affected products: Automated Impella® Controllers (AIC); Lot or serial number: IC9414; Model or catalogue number: 0042-0000-CA
Affected products: Automated Impella® Controllers (AIC); Lot or serial number: IC1179; Model or catalogue number: 0042-0000-US
The hazard
Abiomed has decided to initiate a voluntary medical device recall (removal) for design changes that were previously implemented through the Abiomed field service process. Abiomed performed a retrospective review of Field Change Notices (FCN) and determined that certain AIC consoles in the field did not receive the updates introduced by FCN 113.
Failure to implement the applicable FCN 113 updates may result in the screen freezing during the Purge Cassette Change Wizard and the display of a false controller error.
These defects could delay the initiation of support during device set-up and, in high-risk patient populations, may lead to temporary inadequate hemodynamic support or a temporary loss of hemodynamic support. Hospital inventory may continue to be used to ensure continuity of care. Not all units are affected by this issue.
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)