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

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

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

While neither warning is classified as a recall, the FDA has provided additional information for the two products. Boston Scientific told customers that its Endotak Reliance defibrillation leads with ...

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

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

Boston Scientific faces scrutiny as the FDA issues warnings on two heart devices linked to injuries and deaths. The agency ...

In a letter to physicians, the company noted that there is an increased risk of blockages in the bloodstream depending on the ...

A PEth test is a non-FDA-approved “Laboratory Developed Test” (LDT), used to determine if those monitored in an alcohol, or court ordered, prevention program have consumed alcohol over a 2 - 4-week ...