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

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 ...

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

Boston Scientific has updated the instructions for use for products deployed in the implantation of its Watchman heart device ...

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

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

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

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

The FDA has issued an alert about a potentially high-risk issue involving models of Boston Scientific’s Watchman Access Systems, which are used to provide vascular and transseptal access during ...

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.