MAQUET/GETINGE RECALLS CARDIOSAVE HYBRID AND RESCUE INTRA-AORTIC BALLOON PUMPS (IABPs) FOR UNEXPECTED SHUTDOWNS. FDA RECALL, AUGUST 2023.

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In August 2023 FDA published a Recall about Maquet/Getinge consoles. 

The Company issued a recall for the Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) as they might experience sudden shutdowns due to electrical issues in the Power Unit.  

 

 

 

This issue could lead to a loss of hemodynamic support, which in patients highly dependent on it could result in hemodynamic instability and clinical deterioration. 

Typically, the problem is resolved by restarting the console within 1-2 minutes and restoring the parameters.

In any case, the company recommends having a backup console available at all times or providing alternative hemodynamic support (we understand this refers to vasoactive drugs, Impella, ECMO, or Tandem-Heart).

Source: https://www.fda.gov/medical-devices/medical-device-recalls/datascopemaquetgetinge-recalls-cardiosave-hybrid-and-rescue-intra-aortic-balloon-pumps-iabps