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.
52 Articles
52 Articles

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.
Air Embolism Deaths Tied to Watchman LAA Closure Device Access Systems
(MedPage Today) — More special care is needed when using the Watchman access systems used to deliver transcatheter left atrial appendage (LAA) closure devices due to a risk for air embolisms, according to an FDA alert. Instructions for use have… Source link : https://www.medpagetoday.com/cardiology/interventionalcardiology/116865 Author : Publish date : 2025-08-06 20:20:00 Copyright for syndicated content […] The post Air Embolism Deaths Tied to…
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