FDA recalls Medtronic cardiac medical devices — 4 things to know

The FDA issued a Class I recall — the most serious recall classification — for some of Medtronic’s cardiac resynchronization therapy and implantable cardioverter defibrillators. Here are four things to know.

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1. Forty-eight devices manufactured between July 13, 2013, and August 8, 2017, were recalled nationwide.

2. The devices are intended to pace slow heart rhythms and stop dangerously fast heart rhythms through pacing or electrical shock. A manufacturing defect may prevent the recalled products from providing necessary electrical shocks to pace or revive patients in cardiac arrest.

3. Medtronic issued an urgent medical device recall notice in January, asking patients who were implanted with an affected device to consider prophylactic device replacement. The company will offer a supplemental device warranty for recalled devices.

4. A complete list of serial numbers for affected devices is available on the FDA recall notice.

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