Get a Free Case Review Get a Free Case Review In July 2025, the FDA announced a voluntary recall of Boston Scientific Endotak Reliance ePTFE-coated defibrillation leads after a calcification defect was found to prevent life-saving shocks from being delivered. As of July 24, 2025, Boston Scientific reported 386 serious injuries and 16 patient deaths linked to this issue.
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Who Qualifies
To pursue a claim, there must be an injury caused by a device failure, supported by documentation.
FDA Actions, 2025
The FDA has identified recalls involving certain Boston Scientific ENDOTAK RELIANCE defibrillation leads as Class I recalls, the agency’s most serious recall category. According to the FDA, certain leads with ePTFE-coated coils may develop calcification over time, which can interfere with the delivery of intended defibrillation shocks and may require early replacement. The FDA stated that the issue has been associated with reports of serious injuries and deaths, and recommended ongoing monitoring and evaluation by healthcare providers.
The ePTFE coating on the shocking coils can develop calcium deposits over time. Calcification insulates the coils, gradually increasing lead impedance. As impedance rises, the device may be unable to deliver a shock during cardiac arrest. As of July 24, 2025: 386 serious injuries and 16 deaths reported. ~354,000 leads in service. Most common outcome: early lead replacement (1 in 238 at 10 years). Extraction of long-implanted leads carries an additional serious risk due to calcification.
A peer-reviewed analysis linked coil calcification in Endotak Reliance leads to progressively rising high-voltage impedance, consistent with the defect described in the recall.
PO-06-127 PROGRESSIVE HIGH-VOLTAGE IMPEDANCE RISE IN BOSTON SCIENTIFIC ENDOTAK RELIANCE ICD LEADSA case series documented an increase in high-voltage impedance as a mechanism of failure in transvenous ICD leads, with implications for the management of affected patients.
A review of FDA MAUDE reports from January 2000 through September 2025 found 2,378 reported events for Endotak Reliance leads post-recall: 57.4% injuries, 42.3% malfunctions, and 0.25% deaths. High impedance was present in 26.9% of cases; 54.9% required lead replacement or extraction. Reported complications included infection, inappropriate shocks, and asystole.
Class II recall posted April 10, 2026. Warning letter issued January 28, 2026.
Common Injuries
When a defibrillator lead fails to deliver a shock, a patient in cardiac arrest may not receive the intervention they need to survive.
Calcification raises impedance to the point where the device cannot discharge during a life-threatening arrhythmia.
Patients who experience ventricular fibrillation without a functioning ICD may suffer cardiac arrest. The recall is linked to 16 patient deaths as of July 2025.
Over half of reported cases required lead replacement or extraction — a procedure that itself carries serious risks, especially when the lead has been implanted for many years.
Some patients survived a cardiac event only after external resuscitation, which the FDA identified as one of the most serious possible outcomes of lead failure.
Some patients experienced inappropriate shocks or persistent device alerts due to abnormal impedance readings, resulting in distress and requiring medical intervention.
Lead extraction procedures carry a risk of infection, vascular injury, and other surgical complications that can require extended hospitalization.
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