FDA Warning Wire: Faulty St. Jude Devices Used In Patients

By Emily Field (April 18, 2017, 6:31 PM EDT) -- Cybersecurity and battery problems with heart devices continue to trouble Abbott's St. Jude Medical Inc., whose devices were still being implanted in patients despite a recall over faulty batteries last fall, according to a recent warning letter from the U.S. Food and Drug Administration.

And cybersecurity issues with smart heart devices still haven't been handled to agency's satisfaction, which warned about the problem early in the year.

The FDA also scolded a medical food company for not getting the necessary clearance to study a new product, and found a stomach-churning array of pest problems at a Los Angeles bakery.

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