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Class I Recall Of Datascope Cardiac Assist Devices

 
• By Brian Bossetta

The US Food and Drug Administration has designated a recall of Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps from Datascope/Getinge as class I due to the potential for the pumps to shut down during use.

Handwriting text showing Product Recall.
• Source: Alamy

Datascope, a subsidiary of Getinge, is recalling its Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP) because tears or leaks in the balloon can cause blood to back up into the system leading to a shutdown of the pump, which can then result in organ damage or death.

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