FDA flags problems with two Boston Scientific heart devices tied to injuries and deaths

Key Points

• The FDA has raised concerns about safety issues related to two Boston Scientific heart devices, which have been linked to serious injuries and deaths.
• As of July 24, Boston Scientific reported 386 injuries and 16 deaths associated with its Endotak Reliance defibrillator wires, some linked to device failures.
• In addition, the FDA is warning about updates to the implantation procedures for the Watchman device, which have resulted in 120 injuries and 17 deaths as of July 30.
• Boston Scientific's heart devices account for two-thirds of its $5 billion revenue, and news of the safety issues has led to a nearly 1.8% drop in its stock price.

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.

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.

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