Tag: medical device

FDA Blames Hospitals for Failing to Report Medical Device Safety Problems

At least 12 U.S. hospitals -- including some of the most well-known and respected facilities in the country -- have failed to report patient deaths and injuries linked to medical devices, according to the U.S. Food & Drug Administration (FDA).

/ November 1, 2016
FDA Medical Device Injuries

FDA Launches Website to Report Medical Device Lawbreakers

Heads up, whistleblowers. The FDA has unveiled a new website for anyone to report that a medical device maker is breaking the law — for example, hiding safety reports or "off-label" marketing.

/ October 26, 2016

FDA: Bad Batteries on St. Jude Defibrillators Run Out in 24 Hrs

After two deaths, St. Jude and the FDA warn that bad batteries on nearly 400,000 implantable cardiac defibrillators can run out in 24 hours.

/ October 11, 2016