The Food and Drug Administration (FDA) has announced a recall of specific lots of the Boston Scientific EMBLEM S-ICD (Subcutaneous Implantable Cardioverter Defibrillator) due to a manufacturing error.
The EMBLEM S-ICD is part of the Boston Scientific S-ICD System. The Boston Scientific S-ICD is an implantable cardioverter defibrillator that is intended to provide electrical shock to stop dangerously fast heart rhythms and pacing for a short time after shocks if needed. These cardiac devices are placed under the skin in the upper chest area.
Boston Scientific is recalling the EMBLEM S-ICD because a manufacturing process may allow moisture to get inside the defibrillator and cause a short-circuit when it tries to deliver high voltage shocks. If this happens during use, patients may experience less shock than intended or may not receive a shock at all. The device may also beep, not respond to a device check in, and issue battery alerts.
The manufacturer has received 6 complaints about this device issue. There have been no reports of injuries or deaths. The FDA has identified this recall as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Food and Drug Administration (FDA). Boston Scientific Corporation Recalls EMBLEM S-ICD (Subcutaneous Implantable Cardioverter Defibrillator) System Due to Risk of Short-Circuit [news release]. February 19, 2021. Available at: click here. Accessed February 22, 2021.