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Déjà Vu: Cardiosave Heart Device Racks Up Class I Recall Because Of Battery Problems (Again)

 
• By Shawn M. Schmitt

The US FDA says a recall of Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps is high-risk class I because the devices’ battery packs could fail. This isn’t the first time the pumps have been recalled because of battery troubles.

Handwriting text showing Product Recall.
• Source: Alamy

The US Food and Drug Administration has affixed its highest risk classification, class I, to a recall of battery packs found inside cardiac-assist devices.

Medtech firms Datascope, Getinge and Maquet launched a recall of their Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps (IABPs) on 21 September because their batteries could fail. The pumps...

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