Boston Scientific Implantable Defibrillator Lead Recall

FDA has classified as Class 1 a Boston Scientific recall of its Emblem S-ICD subcutaneous electrode because of an increased risk of fractures at the distal to the proximal sense ring. If the device fractures during use, it could become unable to deliver therapy to slow very fast heartbeats from cardiac arrest (tachycardia), according to a recall notice. A failed device may cause serious adverse events, including injury or death if cardiac arrest cannot be treated or additional surgery to replace failed devices is needed. There have been 27 complaints about the issue, 26 serious injury reports and one death.

The device is part of the company’ S-ICD implantable cardioverter defibrillator system that is intended to provide electrical shock to stop dangerously fast heart rhythms and pacing for a short time after shocks if needed. They are implanted under the skin in the upper chest area.