CanadaThe Automated Impella® Controller (model/catalogue number 0042-0000-CA; serial/lot numbers IC2369, IC2370, IC1572, IC2686, CI1665, IC1544, IC2687) is affected. Abiomed Inc. initiated a voluntary recall after a review found certain units require hardware updates to mitigate risks that could lead to a delay or loss of hemodynamic support, which may result in serious injury or death. 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: Automated Impella® Controller; Lot or serial number: IC2369; Model or catalogue number: 0042-0000-CA
Affected products: Automated Impella® Controller; Lot or serial number: IC2370; Model or catalogue number: 0042-0000-CA
Affected products: Automated Impella® Controller; Lot or serial number: IC1572; Model or catalogue number: 0042-0000-CA
Affected products: Automated Impella® Controller; Lot or serial number: IC2686; Model or catalogue number: 0042-0000-CA
Affected products: Automated Impella® Controller; Lot or serial number: CI1665; Model or catalogue number: 0042-0000-CA
Affected products: Automated Impella® Controller; Lot or serial number: IC1544; Model or catalogue number: 0042-0000-CA
Affected products: Automated Impella® Controller; Lot or serial number: IC2687; Model or catalogue number: 0042-0000-CA
The hazard
Abiomed, Inc. has initiated a voluntary medical device recall (removal) of specific Automated Impella® Controllers (AIC) (Product Code: 0042-0000-CA). A retrospective review of servicing records identified that certain AIC units require specific hardware updates to address potential safety concerns. These updates are intended to mitigate risks that could lead to a delay or loss of hemodynamic support, which may result in serious injury or death.
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)