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.

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

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

The US Food and Drug Administration (FDA) has approved Boston Scientific’s expanded instructions for use (IFU) labelling of the Farapulse pulsed field ablation (PFA) system. The approval marks a ...

The FDA approved Boston Scientific’s Spectra WaveWriter Spinal Cord Stimulator System. 1. The system is the first and only FDA-approved system that simultaneously provides paresthesia-based and ...