Tag: medical device
Boston Scientific Recalls Vici Venous Stents for Migration Risk
Boston Scientific has recalled nearly 32,000 Vici Venous Stents after 17 complaints of the implants moving out of place.
Teleflex Endotracheal Tubes Recalled for Risk of Death
After 4 patients died, Teleflex Inc. has issued a Class 1 recall for certain endotracheal tubes because the connector can disconnect, resulting in loss of oxygenation or death of the patient.
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).
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.
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.