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.
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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.
Results of two studies presented at the Heart Rhythm Society Scientific Sessions support the subcutaneous implantable cardioverter defibrillator as an alternative to ICDs with transvenous leads.
The US agency has updated its Catalog of Regulatory Science Tools.