The US Food and Drug Administration (FDA) has issued a Class I recall of the electrode component of the EMBLEM S-ICD (Boston Scientific), the iconic subcutaneous implantable cardioverter-defibrillator system, due to an increased risk for fracture at a specific location near the proximal sensing ring.
Such a lead failure could prevent the device from delivering shocks as needed, the agency said in its recall announcement, which applies to 19,919 model number 3501 devices manufactured from March 2016 to November 2020 and distributed until November.
“There have been 27 complaints about this device issue and 26 reports of serious injuries. One death has been reported,” the announcement said.
Boston Scientific had issued a safety advisory on December 2 “to all affected customers, with recommendations for prompt identification of devices at risk for electrode body fracture.” The note included instructions for monitoring device function both remotely and radiographically, and for replacement of leads showing evidence of a fracture.