DATASCOPE/MAQUET/GETINGE RECALLS CARDIOSAVE HYBRID AND RESCUE INTRA-AORTIC BALLOON PUMPS (IABPS) FOR PCBA FAILURES AFFECTING THE ABILITY TO CHARGE THE BATTERIES LEADING TO UNEXPECTED SHUTDOWNS. FDA RECALL, AUGUST 2023.

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In August 2023 FDA published a recall about maquet/Getinge IABP consoles. 

 

 

 

The company issued a recall for the Cardiosave Hybrid IABPs due to the possibility of unexpected shutdowns caused by failures in the printed circuit board assembly (PCBA) within the charging path circuit. 

 If this situation arises, the device might lose its ability to charge batteries in one or both battery slots. 

Using an affected pump could lead to severe negative health outcomes in patients with hemodynamic inestability. 

The recommendations are: 

• Not removing the battery when it's at 80% charge or above and actively charging.

• If absolutely necessary to remove the battery before full charge: 

  - Attach the IAB catheter to an alternate IABP console. 

 - Turn off the Cardiosave, disconnect from AC, extract the battery. 

Source: 

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