26-A-14687-ACC Real-World Safety Outcomes of Endotak Reliance Defibrillation Leads: Analysis of FDA Maude Following EPTFE Coating Recall
Recommended Citation
Ghazal R, Ahmed A, Patel K, Memon M, Abdelhai OS, Bawa D. 26-A-14687-ACC Real-World Safety Outcomes of Endotak Reliance Defibrillation Leads: Analysis of FDA Maude Following EPTFE Coating Recall. J Am Coll Cardiol 2026; 87(13):A40-A41.
Document Type
Conference Proceeding
Publication Date
4-7-2026
Publication Title
J Am Coll Cardiol
Abstract
Background: In July 2025, the FDA issued a Class I recall of Boston Scientific Endotak Reliance leads with ePTFE-coated coils due to calcification causing shock impedance rise and potential defibrillation failure. We analyzed real-world safety events to characterize failure patterns and clinical outcomes. Methods: We analyzed FDA MAUDE reports from January 2000 through September 2025. Events were categorized by type, device problem, patient outcome, year-to-year trends, and specific analysis of impedance-related failures and lead interventions. Results: Among 2,378 events, 57.4% (n=1,366) were injuries, 42.3% (n=1,006) malfunctions, and 0.25% (n=6) deaths. Reliance 4-Front models constituted 97.4% of reports. High impedance was the leading problem (26.9%, n=639), followed by dislodgement (3.2%, n=76) and high capture threshold (2.48%, n=59). Lead replacement or extraction was required in 54.9% (n=1,305). Complications included infection (25.4%, n=603), inappropriate shocks (3.2%, n=76), and asystole (1.22%, n=29). Although 61.7% were asymptomatic at detection, calcification (the proposed mechanism) occurred in only 2.4% (n=57). Shock efficacy failure occurred in 0.97% (n=23). Reports surged in 2024-2025 (1,000 in 2024, and 1,273 through September 2025), representing 95.6% of all reports and coinciding with the FDA advisory. Conclusion: Calcification of the shock coil of Endotak Reliance ePTFE-coated leads can increase impedance and reduce shock effectiveness. The FDA advisory underscores the need for ongoing surveillance and monitoring of medical devices, even after FDA approval. About 354,000 devices are still in service therefore routine follow-up of defibrillation systems with ePTFE leads is recommended.
Volume
87
Issue
13
First Page
A40
Last Page
A41
