By Matthew Perrone
WASHINGTON (AP) — US health regulators are warning doctors and patients about safety with two separate Boston scientific heart devices recently linked to injuries and death.
The Food and Drug Administration issued two alerts Wednesday about electrical issues related to the company’s cardiac zap defibrillator system and another issue with cardiac implants used to reduce the risk of stroke.
The agency said some of its Endotak Reliance defibrillator wires could become calcified, leading to a life-saving, shocking obstacle to the heart, according to the FDA.
The defibrillator is surgically located in the chest, monitoring irregular heartbeats and using electric shocks to restore the heart to normal.
As of July 24, Boston Scientific reported 386 serious injuries and 16 deaths related to the issue, the agency said.
The 10 deaths were determined to be due to the device not functioning properly, the company said in an email. Four were linked to attempts to surgically remove the device from the patient, while the other two were deemed unrelated to the implant.
Boston Scientific’s wires were distributed between 2002 and 2021 and became unavailable, the company noted in a letter to doctors. While doctors need to weigh the risks of removal procedures, some patients will need to replace the device.
In another notice, the FDA said Boston Scientific recently updated instructions to implant a Watchman device that closes a portion of the left atrium of the heart to reduce the risk of stroke.
In a letter to the doctor, the company noted that the risk of occlusion in the bloodstream is increased depending on the level of anesthesia in patients undergoing initial implantation procedures. Watchman is an alternative to long-term treatment with blood thinners for patients at high risk of stroke.
As of July 30, the company has reported 120 serious injuries and 17 deaths related to the issue, the FDA said.
The company’s research concluded that safety issues were “not related to the design or manufacturing of Watchman System components.”
Heart devices, including defibrillators and other implants, are Boston Scientific’s biggest business, accounting for two-thirds of $5 billion in revenue for the most recent quarter.
Boston Scientific Corp. stock fell nearly 1.8% on Wednesday, closing at $102.95 in trading.
The Associated Press School of Health Sciences is supported by the Howard Hughes Medical Institution’s Department of Science and Education and the Robert Wood Johnson Foundation. AP is solely responsible for all content.
Original issue: August 6, 2025, 6:48pm EDT
