The FDA alerted about safety concerns with two Boston Scientific heart devices associated with injuries and fatalities. The Endotak Reliance defibrillator wires can calcify, leading to critical failures in delivering shocks, resulting in 386 serious injuries and 16 deaths, ten of which were due to malfunction. The company stated these wires were distributed from 2002 to 2021 and are no longer available, with some patients needing replacements. The FDA also noted updated instructions for the Watchman device to mitigate stroke risks due to increased blockage chances during anesthesia.
The FDA issued alerts regarding safety issues with Boston Scientific heart devices linked to serious injuries and deaths, specifically defibrillator systems and a heart implant.
The company’s Endotak Reliance defibrillator wires can calcify, causing failures in life-saving shocks, leading to 386 serious injuries and 16 associated deaths.
Of the reported deaths, ten were attributed to device malfunction, while others were related to surgical removal attempts or considered unrelated.
Boston Scientific also updated implantation instructions for its Watchman device as increased anesthesia risk may lead to bloodstream blockages.
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