Déjà Vu: Boston Scientific’s Emblem Racks Up Another Class I Recall This Month

19 Feb 2021

• By Shawn M. Schmitt

The US FDA on 19 February designated a recall of the Emblem S-ICD Subcutaneous Implantable Cardioverter Defibrillator as high-risk class I. The recall comes on the heels of a second, separate class I recall for the Emblem electrode on 2 February.

Boston Scientific office buildings in Silicon Valley.

A recall of Boston Scientific Corp.’s Emblem S-ICD Subcutaneous Implantable Cardioverter Defibrillator has been designated as high-risk class I by the US Food and Drug Administration.

It’s the second class I recall for the Emblem system this month.