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.

The update covers devices used in procedures to implant the company’s Watchman heart device.

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

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

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

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

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 ...

A dozen lawsuits have been filed over spinal cord stimulators, which are medical devices surgically implanted to reduce chronic back pain. The suits name device manufacturers, such as Abbott and ...

MARLBOROUGH, Mass., Sept. 17, 2024 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) approval to expand the indication for current ...

The FDA has granted approval to a device made by Boston Scientific to treat atrial fibrillation, the company announced in a Jan. 31 news release. The pulsed field ablation system, called FaraPulse ...