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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)...

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A Year After Exiting The Ventilator Market, Medtronic Recalls Thousands Of Newport Devices

 
• By Brian Bossetta

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Q’Apel Medical Recalls, Discontinues Stroke Therapy System After FDA Warning Letter, Class I Designation

 
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More from Policy & Regulation

FDA Drops Package Labeling Guidance For Hernia Mesh Manufacturers

 
• By Brian Bossetta

The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.

Medtechs Wait For Dividend As UK Spending Review Prioritizes Healthcare And NHS

 
• By Ashley Yeo

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UK Healthtech Center Of Excellence Given Key MHRA Digital Regulation Role

 
• By Ashley Yeo

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