FDA Warns About Safety Issues With Boston Scientific Heart Devices

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By I. Edwards HealthDay Reporter

Medically reviewed by Drugs.com

via HealthDay

THURSDAY, Aug. 7, 2025 — U.S. health officials are warning patients and physicians about safety issues associated with two Boston Scientific heart implants, which have been linked to injuries and deaths.

On Wednesday, the U.S. Food and Drug Administration (FDA) issued two alerts about these devices: One is a defibrillator system used to shock the heart back into rhythm and the other is an implant that lowers stroke risk.

The FDA said some of Boston Scientific’s Endotak Reliance defibrillator wires can become calcified, which may stop the device from working correctly.

Defibrillators are placed in the upper chest and monitor for dangerous heart rhythms. If needed, they send a shock to the heart to get it back to a regular beat.

As of July 24, 386 serious injuries and 16 deaths have been linked to this issue, according to the FDA.

Boston Scientific said 10 of the deaths were caused by the device not working during emergencies. Four others happened during surgery to remove the wires, and two were not related to the device.

These wires were sold between 2002 and 2021 and are no longer on the market, the company said in a letter to doctors.

Some patients may need to have the wires removed and replaced, but doctors are urged to carefully consider the risks, The Associated Press, said.

The FDA also reported a separate issue with the company’s Watchman device, which is used to help prevent strokes.

The Watchman closes off a part of the heart’s left atrium to lower the risk of stroke.

It’s often used in people who are unable to take long-term blood thinners, The AP said.

Boston Scientific recently updated the instructions for using this device. The company found that the risk of blockages in the bloodstream may rise depending on the level of anesthesia used during the initial implantation.

As of July 30, 120 serious injuries and 17 deaths have been linked to this issue.

The company said the problem is not associated with the design or manufacture of any component of the Watchman system.

Heart devices like defibrillators and the Watchman accounted for two-thirds of Boston Scientific’s $5 billion in sales last quarter, The AP said.

Following the FDA’s announcements, shares of Boston Scientific dropped nearly 1.8% on Wednesday, closing at $102.95.

Sources

  • The Associated Press, Aug. 6, 2025, U.S. Food and Drug Administration, Aug. 6, 2025

    • Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

    Source: HealthDay

    Posted : 2025-08-08 00:00

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