The FDA is monitoring a safety issue with Boston Scientific Corporation’s ENDOTAK RELIANCE defibrillation leads, used with implantable cardioverter-defibrillators. Leads manufactured between 2002 and 2021 are affected, with 386 serious injuries and 16 deaths reported by July 24. FDA considers it a high-risk problem, evaluating further regulatory action.
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In July, Boston Scientific warned healthcare providers that calcification of the leads’ ePTFE coating could reduce the effectiveness of life-saving shocks, potentially leading to patient death. The company no longer distributes the affected leads and is working with the FDA to address the safety issue promptly.
Read more at Yahoo Finance: FDA Monitors Safety Issue with Boston Scientific Defibrillator Leads
