What You Need to Know
Boston Scientific has issued a major recall impacting dozens of implantable cardioverter defibrillator (ICD) lead models from the Endotak Reliance, Reliance 4-Site, and Reliance 4-Front families. These leads have been on the market since 2003 for DF-1 models and since about 2009-2010 for DF-4 models.
Because ICD leads are built to last many years, tens of thousands of people may still have these devices implanted worldwide.
Why This Recall is So Serious
The recall is linked to a defect in the ePTFE coating material. This design issue has been shown to cause coil calcification at higher rates than similar products from other manufacturers.
The consequences can be life-threatening:
- 16 deaths reported so far
- 386 serious injuries documented
- Failure of the lead can prevent treatment for ventricular arrhythmia, which is often fatal without immediate intervention
- Removing the leads can be dangerous due to calcification, which increases surgical risk
Who is Affected
Patients who received any of the recalled Boston Scientific ICD leads, including those implanted years ago, may be at risk.
The defect may appear 8 or more years after implantation, meaning problems can arise long after surgery.
If you are unsure whether your device is part of the recall, your implant records or your doctor can confirm the model number.
Why Trust Dunn Sheehan
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Our results speak for themselves. We’ve helped seriously injured victims recover millions of dollars in damages and reclaim their lives.
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Product and pharmaceutical litigation is our specialty. We have the knowledge and resources to successfully challenge sophisticated medical device manufacturers.
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We accept a limited number of cases to ensure we provide each client with the dedication and focus they deserve.
Reclaim Your Life
We can’t change the past, but we can change your future. Use our free tool to find out if you have a case and qualify for financial compensation.
Making Your Case
First, we investigate your claim by collaborating with top medical professionals and gathering evidence of how your Boston Scientific Lead Defibrillator caused your medical condition. Then, we file a product liability lawsuit against Boston Scientific.
If the defendant is willing to negotiate a just settlement, we’ll work with them to get you maximum compensation. If not, we’ll take your case to trial to recover the damages you’ve suffered.
Frequently Asked Questions
Your cardiologist or device clinic can confirm the model number from your implant records or through device interrogation.
The ePTFE coating can calcify over time, increasing the risk of lead failure and making removal more dangerous.
You can use our online case tool to learn whether you have a case or contact us to schedule a consultation.
Dunn Sheehan has handled cases in nearly 40 states and assisted product liability victims across the country. Your location may affect the timeline of our case, as the statute of limitation varies from state to state for product liability claims, but your medical injury lawyer will discuss this with you before taking on your case.
Reported issues include lead malfunction, failed arrhythmia conversion, additional surgeries, and in some cases, death.
In most cases, legal action requires proof of injury or significant risk that has already caused harm.
An attorney can secure records, determine if your lead is recalled, and act before legal deadlines expire.