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FDA slaps Abbott ICD recall with Class I label

August 5, 2019 By Nancy Crotti

The FDA has labeled a recent Abbott (NYSE:ABT) recall of Ellipse implantable cardioverter defibrillators (ICDs) as the most serious type, which could result in patient death.

The company began the recall in June, citing damaged wires in 204 Ellipse pacemakers distributed globally.

Get the full story on our sister site, MassDevice.

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