FDA: Patients with Riata defibrillators should get X-rays

Posted by Sarah Showard | Sep 13, 2012 | 0 Comments


The U.S. Food and Drug Administration recommends that patients with Riata or Riata ST heart defibrillator implants have X-rays or other scans to check for abnormalities in the lead insulation. The manufacturer, St. Jude Medical of Minnesota, recalled the leads in November 2011 due to premature erosion of the insulation around the electrical conductor wires. The company says about 79,000 Riata leads remain in patients nationwide.

An insulation failure might cause the Riata leads to shift, which could lead to inappropriate or no shock therapy and potentially fatal abnormal heart rhythms, according to the FDA. Some studies have shown that routine imaging of the leads could detect insulation abnormalities. The FDA said removing the leads might not be necessary and has ordered St. Jude Medical to conduct follow-up research.

“The majority of Riata and Riata ST leads, including those that show signs of electrical conductor migration or externalization, continue to function normally and provide life-saving support for patients,” said Dr. Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health. “However, the agency does not have enough information to determine the frequency and timing of insulation failure in these leads; therefore, the postmarket surveillance studies will ensure that health care professionals and patients get the data they need to better guide clinical management decisions.”

Further reading:

About the Author

Sarah Showard

Sarah Showard graduated from the University of Maryland in 1985, Magna Cum Laude with a Bachelor of Arts in English-Linguistics and a Certification in Womens Studies. She then graduated from New York University School of Law in 1988. Sarah began practice initially as an insurance defense attorne...


There are no comments for this post. Be the first and Add your Comment below.

Leave a Comment

Showard Law Firm-Tucson's Local Law Firm for defective drug & medical device claims.

Showard 20staff 202017 201026 20special 20edit edit.jpg 20small

Showard Law Firm is dedicated to compassionate representation for our clients who have been injured by defective products, dangerous drugs or the negligence of any individual or company. We are experienced in litigation and ready to ensure you receive the maximum possible settlement for your injuries, medical bills, mental anguish and other losses.

Sarah Showard and Dr. Peter Ott - 2018 Heart Ball Chairs


Sarah and Peter are the proud chairs of this year's Heart and Stroke Ball, held on 2/17/18 at the El Conquistador. With a western theme "Heart of the West", this important fund raiser is in its 60th year, all raising funds to help with research and advances in the case against heart disease in the Tucson community.