Riata Defibrillator Recall Treatment and Use
FDA Recalls Riata and Riata ST Silicone Defibrillators
The U.S. Food and Drug Administration has recalled St. Jude Medical, Inc.’s Riata defibrillator lead over potential risks of injury or death. The company took Riata off the market last year; however, about 79,000 devices are still in use. Riata has been linked to incidents in which wires that run from the device to the heart may poke through the outer coating of their cable, which could result in the device failing to deliver a shock or, conversely, shocking patients unnecessarily.
St. Jude sent doctors a voluntary medical device advisory letter on Nov. 28 regarding the Riata defibrillator deficiencies. In the letter, St. Jude said a flaw with the wires on the Riata defibrillator is more prevalent than previously thought.
When the device was taken off the market in Dec. 2010, St. Jude said the rate of abrasion was 0.47 percent nine years after the original implantation, with 0.047 percent demonstrating “externalized cables.” In its most recent letter to physicians, St. Jude increased the abrasion rate to 0.63 percent.
A study of 212 patients in Ireland who received St. Jude’s Riata defibrillator lead found that 15 percent had suffered such an “insulation breach,” which could interfere with the device’s lifesaving therapy.
What should you do?
Recipients of the recalled Riata leads are advised to consult with their physician as soon as possible. Doctors may design individual treatment plans for those with damaged wires based on their risk level.
The company is not advising all affected patients to have their leads removed or replaced, as attempts at removing these leads can result in injury and death. However, those who are experiencing electrical abnormalities may be advised to have their leads replaced or removed. Patients risk their safety when having the leads taken out, but they also risk their lives if their leads malfunction.
If a malfunctioning Riata lead has caused you or a loved one to experience cardiac difficulty, fill out the contact form to the right to consult with one of our medical lawyers
Class I Recall
A Class I recall from the FDA indicates that use of the medical device will likely result in serious injury, illness or death. The recall includes about 79,000 devices still in use at the time of the initial announcement. Malfunctions associated with Riata and Riata ST Silicone defibrillators have resulted in two deaths and one serious injury.
Models Being Recalled
The following devices are included in the Class I recall:
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
