FDA Recalls St. Jude’s Riata Defibrillator Leads–Estimated 79,000 Patients in the US Implanted with the Device/Leads
Posted Dec 25 2011 2:29am
Apparently they found the silicon covering on the leads is the issue and it could shock patients when they don’t need it or not work at all and have a higher failure rate than first anticipated. St. Jude last year stopped selling the leads. BD
St. Jude Medical Inc.’s Riata defibrillator leads, which the company stopped selling last year, were recalled by the U.S. Food and Drug Administration because of their potential to injure or kill patients
The devices remain implanted in an estimated 79,000 U.S. patients. The company voluntarily sent a letter to doctors on November 28 informing them that the wires used to connect the devices to the heart have a higher failure rate than was previously known.
Leads with externalized conductors may develop electrical dysfunction and not work as intended. In the event the device does not work as intended, should a life-threatening heart rhythm occur, pacing or defibrillation therapy may not be delivered as intended. This may result in serious adverse events, including death. The recall includes the following model numbers: Riata (8F) Silicone Endocardial Defibrillation Leads Models: 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592 Riata ST (7Fr) Silicone Endocardial Defibrillation Leads Models: 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042