Houston medical device injury attorneys: U.S. FDA Class I recalls represent the most serious type of medical device recall. Class I recalls cover those defective medical devices that could lead to serious injury or death.
This Class I recall applies to the Riata and Riata ST Silicone Endocardial Defibrillation Leads manufactured by St. Jude Medical, Inc. The recall stems from premature insulation failure in the recalled implant able cardioverter defibrillator (ICD) leads. The insulation can erode prematurely around the electrical conductor wires.
Riata and Riata ST leads connect an implantable cardioverter defibrillator (ICD) to the heart in order to monitor heart rhythms. ICDs should detect life-threatening heart rhythms and deliver an electrical shock from the ICD to the heart through the ICD lead. ICD leads have layers of insulation to protect the electrical conductor wires inside the lead from corrosion and damage.
Our Houston medical device injury attorneys emphasize that this insulation failure defect can lead to ICD lead malfunctions. The ICD lead malfunctions might cause abnormal sensing or pacing, delivery of inappropriate shock therapy, or NO delivery of needed shock therapy. These insulation failure-related malfunctions could lead to serious adverse health consequences including death. The FDA estimates that almost 80,000 of the defective Riata ICD leads remain implanted within U.S. patients.
The average ICD lead should last about 10 years without erosion or insulation failure. But in the case of the recalled leads, the FDA has received numerous reports of premature failures as early as 4 years after implantation. The Riata ICD lead insulation failure may cause some of the electrical conductors inside the leads to migrate within or externalize outside of the outer lead insulation. These changes might sometimes be detectable on X-ray or fluoroscopic imaging. But imaging detection can sometimes be challenging.
Riata and Riata ST leads that show insulation abnormalities on imaging tests could be at greater risk of future electrical failure and harm to the patient. The FDA suggests that doctors closely monitor patients that have the recalled Riata or Riata ST leads implanted inside them. Patients should receive a recent evaluation and device interrogation to assess for any electrical abnormalities.
The FDA also recommends that doctors consider remote monitoring for patients with a recalled lead to better detect electrical abnormalities. The doctors could also consider performing fluoroscopy of the ICD lead when the generator is replaced in order to check on the condition of the ICD lead.
St. Jude Medical recommends reprogramming the recalled medical devices to increase the chances of detecting a dangerous abnormality in the Riata and Riata ST ICD leads. Our Houston medical device injury attorneys also note that the patient alert and remote monitoring alerts should also be turned on.
The U.S. FDA does NOT recommend replacement of the leads except in cases where the leads show abnormal electrical function and evidence of insulation failure in imaging tests. Removal of the leads is not recommended except where the benefits outweigh the patient risks due to the dangerous risks of explantation surgery on the ICD leads.
The FDA recommends that patients contact their cardiac physicians to find out if they have the recalled leads and to request additional information regarding care and monitoring. If you’ve received an injury from a defective medical device and you need legal advice regarding what to do to obtain fair compensation for the needless harm you’ve suffered, contact our experienced Houston medical device injury attorneys for a free and confidential legal consultation. You could reach us toll free or through our convenient online contact features. Our goal is to help you win the full financial recovery you deserve.