St. Jude Riata Lead Failure Seen in 1 of 10 after Five Years: Study

It appears that the insulation on about one out of every 10 recalled St. Jude Riata leads is failing within the first five years after they are implanted, according to the findings of a new study. 

In a study published online by the medical journal Heart Rhythm on February 15, Danish researchers examined the failure rate for St. Jude Riata defibrillator leads, which were recalled from the market due to problems where the small wires were poking through the insulation.

If problems develop with St. Jude Riata leads, which are used to connect implantable cardiac defibrillators (ICD) to the heart, concerns exist that the device may deliver electrical shocks that are not needed or fail to produce a life-saving jolt when needed.

The study identified all 299 patients with recalled St. Jude Riata leads in Denmark. The researchers used multiple investigators to confirm cases of lead externalization. They found that after 5.1 years, 11% of the leads had become externalized. However, there was no correlation between whether the leads were externalized and how the defibrillator functioned.

St. Jude Riata Lead Recall

A St. Jude recall for the Riata leads was issued in December 2011, after the manufacturer sent several warning letters to doctors about reports of problems with the insulation. 

Approximately 227,000 St. Jude Riata leads have been sold worldwide since the product was introduced in the United States in 2002.  Estimates suggest that approximately 79,000 of the Riata leads remain active in patients in the United States, as the process of attempting to remove the lead is very risky and doctors usually recommend keeping the recalled lead in place unless there is evidence that it has failed.

In August 2012, the FDA issued a safety communication in response to concerns among individuals who still have one of the recalled St. Jude Riata or Riata ST leads, recommending that individuals undergo x-ray or other imaging exams to monitor the condition of the leads.

The agency also indicated at that time that it was ordering St. Jude to conduct additional studies on the potential risk of insulation failures and problems with the debrillator leads, including the newer versions sold under the Riata ST Optim and Durata names.

A growing number of St. Jude Riata lead lawsuits have been filed against the manufacturer, including wrongful death claims that allege that the Riata’s defects lead to patient fatalities.