St. Jude Riata Defibrillator Leads Recalled Due to Malfunction

The FDA has categorized the Riata Defibrillator leads recall a Class I recall due to the potential for severe injuries related to the malfunction of the defibrillator leads. According to the FDA, the defibrillator may malfunction because the leads may penetrate the insulation leading to mechanical failure.
While the St. Jude Riata defibrillators were removed from the market last year, those who’ve had the implanted defibrillators may be at a greater risk of defibrillator malfunction and the FDA is urging consumers who have these defibrillators implanted to check with their physicians about monitoring and follow-up.