Early Alert: Stent And Electrocautery-enhanced Delivery System Issue From Boston Scientific

Boston Scientific is recalling certain stents and delivery systems that use electrocautery-enhanced technology because they may not deploy or expand properly. The recall affects medical devices used in procedures where these stents need to open correctly inside blood vessels or other body structures. Customers who have received or are using these products should contact Boston Scientific for specific information about affected devices.

Recalling firm

Early Alert

Product

Boston Scientific is removing certain stents and delivery systems due to issues with deployment and expansion.

Reason

Boston Scientific is removing certain stents and delivery systems due to issues with deployment and expansion.

Category

medical device recall

Country

United States

Agency

FDA-MEDWATCH-RSS

Recall date

2026-01-16

Status

Ongoing

Official recall notice from FDA-MEDWATCH-RSS

Recall details on Nibble Recalls: https://trynibble.app/recalls/09a590c3-cb47-4a69-87e4-62b23da026c5