Déjà Vu: Boston Scientific’s Emblem Racks Up Another Class I Recall This Month
Executive Summary
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.
You may also be interested in...
Safety Mode Troubles Lead To Class I Recall For Boston Scientific’s Ingenio Pacemakers
The device giant recalled its Ingenio family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps) because there’s a chance they can slip into safety mode, posing a risk to patients. It’s Boston Scientific’s fifth high-risk class I this year.
Boston Scientific’s Vici Stent Systems Subject Of Class I Recall
The company pulled the products from shelves because there’s a chance the stents can migrate, or move, from where they’re placed. This is Boston Scientific’s fourth high-risk class I recall this year.
Death, Serious Injuries Lead To Class I Recall For Boston Scientific’s Emblem Electrode
The US FDA affixed its highest-risk classification to a recall of the electrode, which is part of the company’s Emblem S-ICD system.