US health regulators are warning doctors and patients about safety issues with two separate Boston Scientific heart devices.

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.

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 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 ...

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