Boston Scientific’s ICD Recall Receives a 2nd Class I Warning Label From the FDA
THE UNITED STATES – A news article posted on medtechdive.com reports that the U.S. Food and Drug Administration has issued another warning concerning Boston Scientific’s Emblem subcutaneous implantable cardioverter-defibrillator (S-ICD) system. This is the second Class I recall for this medical device.
Boston Scientific announced three additional field safety notices regarding the medical device within one year. The FDA placed one of the medical device’s faults in a Class I recall, the most serious FDA recall category. Now, the FDA has assigned an additional Class I recall to the medical device. This new FDA warning involves a fault that permits moisture to enter the medical device. When water enters the medial device, an electric short can occur and shocks the patient. Boston Scientific states that there have not been any reported injuries or fatalities connected with the defect, but FDA is treating the issue as a Class I recall for public safety purposes.
Last February, the FDA issued a Class I recall warning concerning the electrode body fracturing risk in certain Emblem S-ICD products, which is designed to prevent sudden cardiac arrest. At that time, Boston Scientific received about 27 reports concerning a fault that might affect more than 47,000 Emblem S-ICD devices the company has distributed nationally since 2017. The reports include 26 patient injuries and one patient fatality.
Boston Scientific announced the defect late last year in a public announcement that also emphasized two system’s other field safety warnings. One of the field warnings describes six reports of “electrical overstress following delivery of high voltage therapy.” Meaning the medical devices had short-circuited. If a patient is implanted with a faulty device and then suffers a cardiac arrest, the patient could sustain serious injuries or be killed should the implant fail to deliver the proper life-saving electrical shock that their heart needs. Although this scenario is a “theoretical risk,” the FDA considers the risk very serious and warrants a Class I recall.
These faults affect a certain subset of EMBLEM S-ICDs that were built with variations in the header assembly and were manufactured between May 2015 and December 2017. Approximately 3,350 of these S-ICDs are affected by the defect. Boston Scientific stated that the variations result in “a very small pathway … that allows moisture ingress, enabling a shorting condition to occur during delivery of high voltage .”
None of the recalled S-ICDs are available for implantation, but thousands of patients live with devices prone to the deadly problem. Boston Scientific and the FDA are asking physicians to address the defect with their patients in the next six weeks. Physicians are also asked to monitor their patients more closely. Boston Scientific is advising against “routine replacement of the devices.”
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