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News You Need to Know Today
News Alert: FDA highlights 2 new safety issues with Boston Scientific devices
Wednesday, August 6, 2025
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News Alert

FDA says Watchman access systems may increase risk of air embolism—17 deaths reported

Because of this risk, which has been associated with 120 serious injuries, Boston Scientific is updating the instructions for use of several Watchman access systems.

READ MORE >
Watchman TruSteer Access System
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FDA says Watchman access systems may increase risk of air embolism—17 deaths reported

Share on Twitter Share on Facebook Share on Linkedin
Watchman TruSteer Access System
Because of this risk, which has been associated with 120 serious injuries, Boston Scientific is updating the instructions for use of several Watchman access systems.
READ MORE >

FDA details defibrillation lead issue linked to 386 injuries, 16 deaths

Boston Scientific manufactured these devices from 2002 to 2021, and approximately 354,000 are still in use. It is recommended that clinicians look for early signs of this issue during scheduled follow-up appointments.

READ MORE >
U.S. FDA Sign
Share on Twitter Share on Facebook Share on Linkedin

FDA details defibrillation lead issue linked to 386 injuries, 16 deaths

Share on Twitter Share on Facebook Share on Linkedin
U.S. FDA Sign
Boston Scientific manufactured these devices from 2002 to 2021, and approximately 354,000 are still in use. It is recommended that clinicians look for early signs of this issue during scheduled follow-up appointments.
READ MORE >

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