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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.

The Food and Drug Administration labelled the recall, which Datascope initiated in December, as class I. The recall covers 4,454 devices distributed from March 2012 until the present.

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