Riata™ Defibrillation Leads
Recipient users of St. Jude Medical Inc.'s Riata™ Defibrillation Lead and Riata™ ST. Silicone Defibrillation Lead should be aware of an urgent recall due to a determination that the devices are defective. According to a notice on the U.S. Food & Drug Administration website, the St. Jude Riata defibrillator lead recall is a Class I recall, the most serious type.
The defibrillator lead is a wire attached to the heart wall that is designed to deliver an impulse via the implanted defibrillator. According to the FDA, the risk of serious injury or death exists if Riata™ or Riata ST. ™ leads malfunction. The FDA recall had to be issued because the wires inside Riata leads can penetrate the outer insulation, compromising the safety and integrity of the device. This defect can cause the inappropriate shock of some patients and a failure to deliver appropriate therapy to others.
Riata leads remain implanted in an estimated 79,000 U.S. patients. Around 227,000 Riata defibrillator leads were sold worldwide. People considered to be at greatest risk if Riata leads malfunction are patients who need frequent defibrillation or are pacemaker dependent. It is recommended that patients continue to be monitored by their doctors and implanted defibrillator systems should be examined with the use of X-rays or fluoroscopy if there is any suspicion of a lead failure. The risks associated with an externalized conductor or the risks and benefits of any management options should discussed with your doctor.
If you or a loved one has received a Riata™ or Riata ST.™ defibrillator lead and wish to discuss your legal options with attorney Jeffrey Bowersox, please call our offices at 503.452.5858 or toll-free 855.269.3776 for a no cost consultation.
Attorney Jeffrey Bowersox will be glad to discuss your options for recovery.