The FDA has announced a recall of Boston Scientific’s EMBLEM S-ICD Subcutaneous Electrode, a key component of the company’s S-ICD system. This is a Class I recall, which means it is an especially serious issue that can result in injury or death.
The S-ICD system is implanted under the skin in a patient’s upper chest area and was designed to slow heart rhythms and electrical shock or pace especially fast heart rhythms. The EMBLEM S-ICD Subcutaneous Electrode is being recalled due to an “increased risk of fractures.”
“If the device fractures during use, it could become unable to deliver therapy to slow very fast heartbeats from cardiac arrest (tachycardia),” according to the FDA’s announcement. “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.”
The FDA reported that there have been 27 complaints about this specific issue, including 26 “reports of serious injuries” and one death.
Boston Scientific alerted customers of this issue in December 2020, sending an Important Medical Device Advisory letter that detailed what to look for and how to evaluate the potential risks. That letter, and other product advisories from the company, is available on the Boston Scientific website.
The model number of this specific part is 3501. It was manufactured from March 2016 to November 2020 and distributed from June 2017 to November 2020. More than 19,000 units were impacted by this recall.
The full FDA announcement can be read here.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.