Boston Scientific

Rule Changes

Recalling unused Infinion CX leads; transitioning to Infinion Pro

Boston Scientific pulled unused spinal cord stimulator leads from the market after the FDA linked them to more than 1,000 serious injuries. The Infinion CX lead, which delivers electrical pulses to mask chronic pain, can fracture where it anchors to the spine.

Updated 4 days ago

Rule Changes

Discontinued the Imager II catheter line; directing customers to return product

Boston Scientific told hospitals to stop using every Imager II Angiographic Catheter it has sold. The tips were made with too little stabilizing agent, which raises the risk they could degrade and detach inside a patient's blood vessel.

Updated Sep 3

New Capabilities

Competitor with FDA-approved pacing lead for left bundle branch area

For decades, defibrillators have saved lives by shocking dangerously fast rhythms back to normal, but the leads also pace the heart unnaturally and can cause damage over time. Medtronic's OmniaSecure lead is the first defibrillation lead that can pace through the heart's own electrical wiring, closely mimicking natural heartbeats. It has been cleared by the FDA for placement in the left bundle branch area.

Updated May 30