St. Jude likely to receive FDA warning letter following inspection of California manufacturing facility
St. Jude Medical Inc. believes it is likely to face a regulatory warning letter on the heels of a recent Food and Drug Administration inspection of a California manufacturing facility that makes some of its troublesome cardiac defibrillator leads. According to a Reuters report this week, St. Jude CEO Dan Starks informed … [Read more...]
St. Jude Says Analysis Shows Durata Lead Failure Not Related to Riata Flaws
St. Jude Medical has acknowledged that one of its Durata defibrillator lead wires suffered from "externalized abrasion," but denies that the model suffers from the same type of critical flaw that forced it to pull its Riata lead wires from the market. According to St. Jude, the externalized abrasion seen with one Durata wire is … [Read more...]
Top Doctor Says St. Jude Durata Lead Failure Report is Credible
A top cardiologist is of the opionion that a Durata lead failure report is, in fact, credible. We recently wrote that the U.S. Food & Drug Administration (FDA) received a report of a St. Jude Durata cardiac defibrillator lead wire breaking free of its insulation, a potentially dangerous and life-threatening defect that has led to … [Read more...]
Report Raises Concerns Over St. Jude’s Durata Heart Defibrillator Leads
The Food and Drug Administration (FDA) has recently received a report of a St. Jude Durata cardiac defibrillator lead wire breaking free of its insulation, a potentially dangerous and life-threatening defect that had been the demise of previous models of these medical devices. According to a Bloomberg report this week, a physician … [Read more...]
