FDA Issues Class I Recall for Emblem S-ICD Over Electrode Fractures

The US Food and Drug Administration has issued a Class I recall of Boston Scientific’s Emblem S-ICD subcutaneous electrode because of an increased risk of fracture that might prevent the ICD from delivering lifesaving therapy.

Specifically, there is a risk of a break on the subcutaneous electrode distal to the proximal sensing ring; if this fracture occurs during use, the ICD would fail to deliver defibrillation necessary to protect against sudden cardiac death.

The recall affects 19,919 Emblem S-ICDs (model number 3501) in the US, all of which were distributed from June 2017 onwards.

Boston Scientific alerted hospitals and physicians about this problem back in December 2020, which the FDA opted to classify as a Class I recall this week. To date, there have been 27 reports of electrode body fractures, including 26 serious injuries and one death. The occurrence rate of fracture is said to be 0.2% at 41 months and the potential for life-threatening harm is 0.004% at 10 years, according to the company. 

In its December letter to physicians, Boston Scientific provided updated information about the performance of the device and recommendations for how to monitor patients with devices that might be at risk for fracture. The company recommends enrolling patients in remote monitoring to “detect any alerts or artifacts on the devices in between office device checks.” If non-physiologic, mechanical artifacts are found, it may be a sign of electrode body fracture. They recommend replacing any electrode with compromised integrity as evidenced by artifacts, high impedance alerts, and/or X-ray.

Other recommendations on “what to do” are available on the FDA website.