FDA: Risks Can Be Fatal
These wires are implanted to connect a cardioverter defibrillator (ICD) to the heart for rhythm monitoring. They should typically function properly for about 10 years, but Riata leads begin to malfunction at a troubling rate after only 4 years, the FDA reported. This can lead to severe problems, including delivering inappropriate shocks or failing to deliver them when urgently needed.
These consequences can be deadly, the FDA warned.
Study: 1 in 3 Recalled Riata Defibrillator Leads Is Defective
Riata and Riata ST defibrillator leads (wires) were the subject of an FDA Class 1 recall — the most serious type of recall — in 2011.
The manufacturer of these products, St. Jude Medical, had already stopped selling these products. But this did not come until more than 227,000 Riata leads had already been circulated worldwide. At the time of the 2011 recall, 79,000 Riata leads remained implanted in patients in the U.S., according to St. Jude.
Riata and Riata ST lead failure, by the numbers:
- Protruding wires were found in 33.3% of patients implanted with Riata and Riata ST leads, according to a Vanderbilt University study.
- 671 confirmed cases of problems with Riata and Riata ST leads, according to a 2012 St. Jude Medical study.
- Riata lead failures are to blame for 22 deaths, according to a March 2012 article in the medical journal Heart Rhythm.
At the Brooks Cutter Law Firm, we are dedicated to helping those who have suffered from Riata or Riata ST lead failures receive the compensation they deserve. Contact us today for a free, no-obligation consultation to learn about your legal rights and options.
The reports show the severity of Riata and Riata ST lead failure. By taking legal action, we can help you seek justice for health complications you have experienced or are currently experiencing as a result.
If you or a loved one has been harmed by Riata or Riata ST lead failure, contact our attorneys at Brooks Cutter Law Firm today for a free consultation.