FDA Monitors Safety Issue with Boston Scientific Defibrillator Leads

Boston Scientific Corporation (NYSE:BSX) is one of the best high-volume stocks to invest in. On August 6, the FDA announced that it is monitoring a safety issue with Boston Scientific Corporation’s ENDOTAK RELIANCE defibrillation leads, which are used with implantable cardioverter-defibrillators to prevent sudden cardiac death.

Earlier this year, the company sent a letter to healthcare providers on July 24, warning that calcification of the leads’ expanded polytetrafluoroethylene/ePTFE coating could lead to a gradual increase in low-voltage shock impedance/LVSI. This can reduce the effectiveness of life-saving shocks and even result in patient death.

The affected leads were manufactured and distributed between 2002 and 2021 and are no longer available. As of July 24, Boston Scientific had reported 386 serious injuries and 16 deaths linked to this issue. The FDA has categorized this as a potentially high-risk problem and is actively reviewing data to determine further regulatory action.

Boston Scientific Corporation (NYSE:BSX) develops, manufactures, and markets medical devices for use in various interventional medical specialties worldwide. It has 2 segments: MedSurg and Cardiovascular.

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Disclosure: None. This article is originally published at Insider Monkey.