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Another Class I Recall For Medtronic, This Time For Defibrillators

 
• By Shawn M. Schmitt

The US FDA on 12 April affixed its highest risk classification to a recall of certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) made by Medtronic. It’s the third class I recall for the medtech giant since 1 March.

Medtronic sign.

A recall by Medtronic PLC of certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) has been designated as high-risk class I by the US Food and Drug Administration.

The recalled defibrillators – sold under the names Amplia, Brava, Claria, Compia, Evera, Visia and Viva – were distributed between August 2012 and May 2018

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