Boston Scientific recalls EMBLEM S-ICD subcutaneous electrode (model 3501) due to risk of fractures.

Boston Scientific is recalling the EMBLEM S-ICD Subcutaneous Electrode because of increased risk of fractures at a specific point (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). A failed device may cause serious adverse events. Examples include injury or death if cardiac arrest cannot be treated or need for additional surgery to replace failed devices. There have been 27 complaints about this device issue and 26 reports of serious injuries. One death has been reported.The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.