The U.S. Food and Drug Administration has issued safety warnings regarding two Boston Scientific heart devices after reports of serious health complications, including injuries and deaths.
The FDA’s alerts focus on electrical malfunctions in Boston Scientific’s Endotak Reliance defibrillator wires, which can calcify and fail to deliver critical life-saving shocks to patients experiencing irregular heartbeats. These defibrillators are implanted in the chest to monitor and correct dangerous heart rhythms.
As of July 24, the company has reported 386 serious injuries and 16 deaths related to this device issue. Ten of those deaths were directly linked to device failure, while other fatalities were connected to device removal procedures or unrelated causes.
The wires were distributed from 2002 to 2021 and are no longer available, but some patients may require replacement devices. Doctors are advised to carefully evaluate the risks involved in removal surgeries.
In a separate notice, the FDA highlighted updated guidelines for Boston Scientific’s Watchman implant, which is designed to reduce stroke risk by sealing off part of the heart’s left atrium.
The agency warned that the implantation procedure carries an increased risk of blood clots depending on anesthesia levels used during surgery. Since July 30, there have been 120 reported serious injuries and 17 deaths linked to this device.
Boston Scientific’s investigation found no design or manufacturing flaws in the Watchman system, but the FDA’s warnings underscore the importance of close monitoring of patients receiving these implants.
Heart devices are a major part of Boston Scientific’s business, accounting for two-thirds of its recent quarterly revenue. The company’s stock dropped nearly 1.8% following the FDA announcements.
Patients and healthcare providers are urged to stay informed about these safety issues to make the best decisions regarding treatment and device management.
READ MORE
HHS Cuts $500 Million in mRNA Vaccine Funding, Raising Health Concerns
HEPA Air Purifiers Shown to Lower Blood Pressure, Offering Heart Health Benefits
