While neither warning is classified as a recall, the FDA has provided additional information for the two products. Boston ...

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

The FDA is reviewing Boston Scientific's defibrillator leads after reports of rising shock impedance and 16 related deaths.

Boston Scientific has updated the instructions for use for products deployed in the implantation of its Watchman heart device ...

Boston Scientific is recommending updates to the instructions for use to minimize the issue, which has been tied to 17 deaths ...

A company spokesperson said in a statement to MedTech Dive that direct causation between the deaths and calcification of the ...

The FDA has issued an early communication to warn of updated instructions for use for certain Boston Scientific Watchman access systems.

The FDA has issued an alert about a potentially high-risk issue involving models of Boston Scientific’s Watchman Access Systems, which are used to provide vascular and transseptal access during ...

Key Takeaways Two Boston Scientific heart devices have been linked to serious injuries and deathsOne device may fail to ...

WASHINGTON -- The Food and Drug Administration cited Boston Scientific Corp. for "serious regulatory problems" involving the manufacturing process for implantable devices used to give medications ...