FDA classifies recall of ICD subcutaneous electrode as Class I
The FDA classified Boston Scientific’s recall of its implantable cardioverter defibrillator subcutaneous electrode as Class I, the most serious type, after it determined use of these devices may cause serious injuries or death.
According to an agency press release, the reason for the recall of the device (Emblem S-ICD Subcutaneous Electrode, Boston Scientific) is due to increased risk for fractures or separation, usually occurring distal to the proximal sense ring. If fracture occurs during use, the ICD may be unable to deliver therapy to prevent cardiac arrest from tachycardia.
There have been 27 complaints about this issue; 26 reports of serious injuries; and one death.
Boston Scientific’s subcutaneous ICD is intended to provide pacing for slow heart rhythms and electrical shock or pacing to stop dangerously fast rhythms. These devices are implanted under the skin in the upper chest area.
On Dec. 2, 2020, the company sent an advisory letter to all affected customers and physicians with recommendations for prompt identification of devices at risk for fracture. According to the release, recommendations for care of recalled devices included:
- Enroll and monitor patients through remote monitoring (Latitude, Boston Scientific) to detect any alerts or artifacts on the devices in between office device checks;
- ask patients to do weekly remote checks; and
- perform a system follow-up every 3 months by remote or in-office checks.