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

  • U.S. health regulators have warned about safety issues with two Boston Scientific heart devices linked to injuries and deaths, according to the Food and Drug Administration.
  • As of July 24, Boston Scientific reported 386 serious injuries and 16 deaths associated with these devices, according to the agency.
  • Ten of the deaths were due to the device failing to function properly, as noted by Boston Scientific in an email.
  • Heart devices account for two-thirds of Boston Scientific's $5 billion in revenue for the most recent quarter, according to internal company data.
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FDA flags problems with two Boston Scientific heart devices tied to injuries and deaths

U.S. health officials have issued warnings on two separate Boston Scientific heart devices recently linked to injuries and deaths.

·United States
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The Business Journal broke the news in on Wednesday, August 6, 2025.
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