St. Jude ICD Lead Recall Lawyers
The product liability lawyers at Saiontz & Kirk, P.A. previously reviewed claims for individuals who experienced problems with St. Jude Riata or Riata ST leads, which may pose a risk of serious and potentially life-threatening injury. New cases are no longer being accepted. This page is maintained for informational purposes only.
A St. Jude Riata recall was issued in December 2011, due to problems with the insulation on the leads, which are small wires that connect a defibrillator or pacemaker to the heart. The wires may become exposed inside the body, leading to a risk of:
- Painful and Unnecessary Shocks
- Failure of the ICD to Deliver Life-Saving Shock When Needed
- Additional Surgery to Remove or Replace the Leads
As a result of a failure to manufacturer the leads consistently, financial compensation was pursued through St. Jude Riata lead lawsuits. New cases are no longer being accepted. This page is maintained for informational purposes only.
ST. JUDE RIATA LEAD PROBLEMS
St. Jude Riata leads are small wires that attach to an implantable cardiac defibrillator (ICD). They are then inserted through a major vein and attached directly to the inside of the heart. The wires contain electrodes that are designed to monitor the heart’s rhythm and correct irregular beats.
Due to manufacturing problems, the St. Jude Riata lead has become vulnerable to abrasion, which can allow the small wire to poke through the insulation, resulting in a dangerous failure that is known as “externalization”.
St. Jude Riata lawsuits filed in courts throughout the United States allege that the manufacturer failed to manufacture the Riata lead consistent with the FDA approved processes, creating a defective product.
The lawyers at Saiontz & Kirk, P.A. are previously reviewed potential claims on the basis of the following allegations:
- St. Jude Riata leads feature inconsistent insulation diameters, which can lead to problems with abrasion at thinner insulation sites.
- St. Jude inconsistently applied a lubcricous interface between the inner and outer insulation, which may have increased friction and promoted abrasion.
- St. Jude failed to properly cure and sterilize during the manufacture of the leads, which may have resulted in reduced strength of the silicone insulation.
- St. Jude failed to crimp the leads with a controlled, uniform degree of force, which resulted in insecure crimps over the length of the lead.
As a result of these St. Jude Riata problems, the wires may become exposed inside the body, allowing them to come into contact with fluids and materials that may prevent the leads from functioning. This could cause the leads to short and transmit incorrect information to the defibrillator, resulting in painful shocks of electricity that are not needed, or a failure of the ICD to function when it is needed to deliver a shock for life-saving therapy.
ST. JUDE RIATA RECALL
Since the Riata leads were introduced in 2002, approximately 227,000 of the small wires were implanted in patients worldwide. Due to the risks associated with removing the small wires, there are still approximately 79,000 leads active in the United States
Although St. Jude Medical knew or should have known about the Riata lead problems, they continued to sell the device for several years without adequately warning consumers or the medical community.
In December 2010, St. Jude sent a letter to the physicians warning that the Riata and Riata ST Family of Silione Leads were found to have an abrasion rate of 0.47% over nine years of use. Although they indicated that the leads would be removed from the market by the end of 2010, no official recall was issued at that time for consumers.
A second letter was sent by St. Jude in November 2011, again warning about the insulation problems. The St. Jude Riata lead failure rate was updated, to indicate that the abrasion rate had increased to 0.63%, but they still failed to issue a Riata lead recall.
Following that letter, in December 2011, the FDA did classify the removal of the St. Jude Riata lead from the market as a recall. The FDA confirmed that the leads pose a risk of failure associated with lead insulation abrasion, which may cause the conductors to become externalized. The action was categorized as a Class I Medical Device Recall, suggesting that there is a reasonable probability that use of or exposure to the Riata leads will cause serious injury or death.
ST. JUDE RIATA CLASS ACTION LAWYERS
As a result of the actions of the manufacturer, financial compensation was pursued for individuals who received one of these recalled leads through a St. Jude Riata lawsuit or class action claim. New cases are no longer being accepted. This page is maintained for informational purposes only.