St. Jude Riata Defibrillator

Riata Defibrillator

Also called Riata ST leads, the St. Jude Riata defibrillator leads were recalled in December 2011. What happened? The lead wires had insulation problems. These leads connect the heart to the pacemaker or defibrillator. These defibrillators are sometimes called ICDs (Implantable Cardiac Defibrillators). ICDs are designed to monitor the heart's rhythm and to provide life-saving shocks in the event of irregular heartbeats. This particular type of lead wire was created in 2002, and approximately 227,000 have been implanted in patients.

Injuries Caused By Defective St. Jude Riata Leads

The recalled Riata leads can cause several injuries for patients. If the wire becomes exposed because of inadequate insulation, the lead is defective. If so, the patient may experience:

  • painful and unnecessary shocks to the heart
  • failure of the ICD device when life-saving shocks are required
Negligence Of St. Jude Medical, The Manufacturer

Several news reports and medical journal articles have explained how St. Jude Medical was negligent, both in the manufacture of the leads, and in warning doctors and patients about the defects. Not only will patients have claims for defective design or negligent manufacture, but they will also have claims for failure to warn.

Failure to WarnRiata Claims

Many doctors encountered problems with the leads. Physicians from Johns Hopkins in Baltimore, the University of Pittsburgh and the Royal Victoria Hospital, for instance, noticed abrasion from 2009 to 2009. The company line appeared to be that those were all isolated incidents. Despite these warning signs, St. Jude Medical delayed warning letters to doctors until December 2010 and November 2011. The first letter advised doctors that the leads had an abrasion rate of 0.47% over nine years. Abrasion refers to the wearing down of the insulation. Recognizing they had a problem, the first letter also advised doctors that the leads would be recalled before 2011. No St. Jude Riata lead recall occurred, however. The second letter, St. Jude informed doctors that the abrasion rate had increased to 0.63%, but they failed to recall the devices. The FDA later recalled the leads using Category Class I (the most serious category of recall, indicating a reasonable probability of death or other adverse health consequences). Most concerning is that St. Jude performed an internal audit of the Riata leads which concluded in 2008. That audit revealed significant problems, and no action was taken.

Contact Us

If you or a loved one had St. Jude defibrillator leads installed, or had a pacemaker or defibrillator installed in the past eleven years and don't know what kind of leads were used, contact our St. Jude Riata recall lawyers at 1.800.553.8082, or online.

For More Information

Content Written By Attorney Ronald V. Miller

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