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Class I Recall Announced On Cardiosave Cardiac Assist Devices After Patient Death

 
• By Elizabeth Orr

The recall, which is related to the risk fluid leaks may make the pumps shut down during use, comes only a few months after battery packs used in the pumps were recalled.

The Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps (IABPs) are being recalled due to reports that fluid leaks may cause the pumps to fail, the US Food and Drug Administration announced on 16 December.

The IABPs, which are manufactured and distributed by Getinge AB/Datascope/Maquet, are cardiac assist devices used during surgery and to...

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How The EU’s Digital Omnibus Package Could Provide Breathing Space For Medtech

 
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