The Medical Device Business Journal — Medical Device News & Articles | MassDevice
MASSDEVICE ON CALL — Patients implanted with St. Jude Medical’s (NYSE:STJ) Riata defibrillator leads, which the medical device company recalled late last year, are finding themselves on the hook for hefty medical bills for replacing the defective wires.
MASSDEVICE ON CALL — The problems with St. Jude Medical’s (NYSE:STJ) recalled Riata defibrillator leads should have been caught sooner, according to a prominent heart doctor.
Dr. Robert Hauser, of the Minneapolis Heart Institute, in an article for the New England Journal of Medicine, wrote that problems with the leads, which remain active in an estimated 79,000 U.S. patients, went uncovered for too long because of lax post-market surveillance.
Physicians from the Minneapolis Heart Institute Foundation and the Mayo Clinic will huddle with electro-physiologists in the Twin Cities Jan. 20 to discuss strategies for dealing with the recall of the Riata defibrillator leads made by St. Jude Medical Inc. (NYSE:STJ).
The FDA slapped the St. Paul, Minn.-based cardiology device maker with a Class 1 recall for the Riata leads in December, after the company said they failed more frequently than previously reported.
The FDA slapped St. Jude Medical Inc.’s (NYSE:STJ) Riata with a Class I recall after the company said the defibrillator leads failed more frequently than previously reported.
Danish researchers reported this week that their latest studies of St. Jude Medical‘s (NYSE:STJ) recalled Riata defibrillator leads found that 1 in 10 had poked through their coating in an average of just over 5 years.
U.K. regulators issued new updates to physicians handling patients implanted with St. Jude Medical‘s (NYSE:STJ) recalled Riata defibrillator wires, urging continued monitoring for failures that may prompt replacement.
MASSDEVICE ON CALL — The FDA’s updated its guidance on St. Jude Medical‘s (NYSE:STJ) recalled Riata defibrillator wires isn’t sitting well with all physicians.
The kerfluffle over a study linking 22 deaths to St. Jude Medical‘s (NYSE:STJ) recalled Riata defibrillator leads picked up a new player: Ohio cardiologist Dr. Edward Schloss.
