2 deaths lead to recall of St. Jude heart devices

The devices shock dangerously racing heartbeats back to their normal rhythm or to treat heart failure. All the devices, called implantable cardiac defibrillator (ICDs) and cardiac resynchronization therapy defibrillator (CRT-Ds), contain batteries that were manufactured before May 23, 2015, when the company added insulation to reduce the chance of an electrical short circuit.

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Monitor battery levels at home

The recall comes as St. Jude is defending itself against unrelated allegations that its heart devices are riddled with defects that make them vulnerable to cyber hacks.

Those claims were made by Muddy Waters and research firm MedSec Holdings. St. Jude has denied the allegations and sued both firms.

“Despite the allegations, at this time, the FDA strongly recommends that the Merlin@Home device be used to monitor the battery for these affected devices because the benefits of continued patient monitoring and the life-saving therapy these devices provide greatly outweighs any potential cybersecurity vulnerabilities,” the FDA said in a statement.

Medtronic in November recalled three models of its InSync III pacemakers due to battery problems, but overall company pacer sales continued to grow sharply thanks to newer products, Taylor said.