FDA flags problems with two Boston Scientific heart devices tied to
injuries and deaths
[August 07, 2025]
By MATTHEW PERRONE
WASHINGTON (AP) — U.S. health regulators are warning doctors and
patients about safety issues with two separate Boston Scientific heart
devices recently linked to injuries and deaths.
The Food and Drug Administration issued two alerts Wednesday about
electrical problems tied to the company's heart-zapping defibrillator
systems and a separate issue with a heart implant used to reduce stroke
risk.
The agency said some of the company's Endotak Reliance defibrillator
wires can become calcified, leading to failures in delivering
life-saving shocks to the heart, according to the FDA.
Defibrillators are surgically placed in the upper chest, where they
monitor irregular heartbeats and use electrical shocks to jolt the heart
back to normal.
As of July 24, Boston Scientific has reported 386 serious injuries and
16 deaths associated with this issue, the agency said.
Ten of the deaths were judged to be due to the device failing to
function properly, the company said in an email. Four were linked to
attempts to surgically remove the devices from patients and two others
were deemed unrelated to the implants.
Boston Scientific's wires were distributed between 2002 and 2021 and are
no longer available, the company noted in its letter to doctors. Some
patients will need to have the devices replaced, though physicians
should weigh the risks of the removal procedure.
In a separate notice, the FDA said Boston Scientific recently updated
instructions for implanting its Watchman device, which closes a portion
of the heart's left atrium to reduce the risk of stroke.
[to top of second column]
|
The Boston Scientific logo is seen at company offices in Fremont,
Calif., Feb. 1, 2017. (AP Photo/Marcio Jose Sanchez, File)
 In a letter to physicians, the
company noted that there is an increased risk of blockages in the
bloodstream depending on the level of anesthesia for patients
undergoing the initial implantation procedure. Watchman is an
alternative to long-term treatment with blood thinners for patients
at increased risk of stroke.
As of July 30, the company has reported 120 serious injuries and 17
deaths related to the issue, the FDA said.
A company investigation concluded that the safety issue “is not
associated with the design or manufacture of any component of the
Watchman system.
Heart devices, including defibrillators and other implants, are
Boston Scientific’s largest business, making up two-thirds of its $5
billion in revenue for the most recent quarter.
Shares of Boston Scientific Corp. fell nearly 1.8 percent Wednesday
to close at $102.95 in trading.
All contents © copyright 2025 Associated Press. All rights reserved
 |
