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

The specifics surrounding the incidents involve the access systems used during implantation procedures for sedated patients ...

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

The FDA has issued an alert regarding a safety concern with certain Boston Scientific defibrillator leads used in implantable cardioverter defibrillators. The affected models include Endotak Reliance, ...

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

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

Shortly after obtaining a green light from the FDA, SetPoint Medical announced $140 million in new funding to juice the ...

Abbott and Boston Scientific are among the investors in SetPoint, whose neurostimulation device gained FDA approval last ...