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

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 ...

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

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

Boston Scientific reported Q2 2025 sales of over $5bn, a 22.8% rise on Q2 2024, besting previous growth estimates of 19.5% at the high end.

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 ...

The FDA approved Boston Scientific’s Infinion 16 Percutaneous Lead for its Precision Plus Spinal Cord Stimulator system, according to a news release. This is the first 16-contact percutaneous lead for ...