The FDA has issued a public update regarding Boston Scientific’s ENDOTAK RELIANCE Defibrillation leads, highlighting potential risks tied to expanded polytetrafluoroethylene (ePTFE) coated coils. This advisory affects healthcare providers, clinical teams, and regulatory professionals managing defibrillation systems. The notice identifies complications that could impact life-saving shock delivery, including early lead replacement needs and, in severe cases, patient fatalities.
Affected Products and Key Details
The advisory concerns specific models from Boston Scientific’s ENDOTAK RELIANCE and RELIANCE 4-SITE product lines. These devices include ePTFE-coated defibrillation leads, which are associated with risks of tissue ingrowth and calcification over time.
- Product Lines: ENDOTAK RELIANCE, RELIANCE 4-SITE, and RELIANCE 4-FRONT.
- Risk Identified: Gradually rising low-voltage shock impedance (LVSI), potentially leading to shock delivery failures during cardiac arrest.
- Reported Incidents: 386 serious injuries and 16 deaths as of July 24, 2025.
Boston Scientific emphasizes monitoring impedance levels. Replacement is recommended for leads with impedance over 150 ohms due to documented risks of failure. Healthcare providers are urged to carefully evaluate the risk-benefit ratio of lead extraction versus abandonment, particularly in cases involving longer implant durations.
Clinical Impact: What Healthcare Providers Need to Know
Why is this alert significant?
Calcification of the defibrillation lead coil can lead to encapsulation and electrical insulation, impairing the device’s ability to deliver effective shocks during cardiac events. This condition is more prevalent in ePTFE-coated leads compared to non-coated alternatives.
How should defibrillation systems be monitored?
Boston Scientific provides detailed recommendations for follow-up:
- Implement regular in-person or remote monitoring to detect impedance trends early. Remote monitoring may expedite identification of gradually rising LVSI patterns.
- Evaluate LVSI and high-voltage shock impedance (HVSI) regularly, with programming adjustments as necessary:
- Single coil leads: Program shocks to maximum energy if LVSI exceeds 90 ohms.
- Dual coil leads: Apply maximum energy if LVSI levels surpass 70 ohms.
What steps should providers take for high-risk leads?
Leads over 150 ohms should undergo replacement planning, with consideration for:
- Adverse effects linked to extraction procedures, particularly for leads implanted for extended periods.
- Potential for calcification to cause increased extraction-related complications.
Providers are cautioned that delivering commanded shocks to calcified ePTFE coils may temporarily alleviate impedance but does not mitigate progression. Routine defibrillator replacements should include comprehensive decision-making if compromised leads exist.
Guidance and Resources for Implementation
Boston Scientific’s communication includes resources for professionals:
- FDA Medical Device Recall Database
- Access to a patient letter and healthcare provider letter detailing suggested actions.
- Technical support contacts for Boston Scientific: tech.services@bsci.com or 1-800-227-3422.
Additionally, healthcare professionals may report adverse reactions or device quality issues via FDA’s MedWatch system.
Conclusion
This advisory underscores the importance of vigilance and monitoring for Boston Scientific defibrillation systems with ePTFE-coated leads. Proper mitigation and risk evaluation strategies are critical to ensuring patient safety and device efficacy. Healthcare teams are urged to distribute the advisory within their organizations and adhere to recommended follow-up protocols.
Disclaimer
This content is intended for informational purposes only and does not constitute legal or professional advice. Stakeholders should consult official regulatory and manufacturer resources before making clinical or operational decisions.
Mandatory FDA Line
For full information about the FDA announcement, see the link below.