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

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

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.

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

“We are very pleased to receive FDA approval for these advanced devices, and excited about the potential they bring to our bradycardia business,” said Joe Fitzgerald, senior vice president and ...