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

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

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 ...

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

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 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 Corp.’s BSX 1.41% controversial surgical device for preventing strokes has been approved for sale by the Food and Drug Administration, the company said on Friday, concluding a ...

WASHINGTON -- The Food and Drug Administration cited Boston Scientific Corp. for "serious regulatory problems" involving the manufacturing process for implantable devices used to give medications ...