What’s the Problem?
This FDA Recall began on Dec. 2, 2020, and affects:
- Boston Scientific EMBLEM S-ICD Subcutaneous Electrode Model Number 3501
“There have been 27 complaints about this device issue and 26 reports of serious injuries,” FDA said. “One death has been reported.”
The Boston Scientific EMBLEM S-ICD Subcutaneous Electrode Model 3501 is part of an implantable cardioverter defibrillator that is designed to provide pacing for slow heart rhythms and electrical shock or pacing to stop dangerously fast heart rhythms. The recalled electrodes were manufactured from March 2016 to November 2020, and distributed between June 2017 and November 2020.
Affected electrodes have been found to fracture at the distal to the proximal sense ring, according to the FDA . This could cause the device to become unable to deliver therapy to slow very fast heartbeats from cardiac arrest (tachycardia), resulting in serious adverse events including injury or death.
Patients at the greatest risk for electrode fracture include:
- Those who have a history of life-threatening ventricular arrhythmias such as secondary prevention
- Those who are unable to be reliably followed remotely or in person every three months
- Those who are not monitored via LATITUDE and are unable to hear beeping tones
Customers who have additional questions should contact the Boston Scientific Technical Services team at (800)-CARDIAC (227-3422).
Do I Have a Boston Scientific Electrode Class Action Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Boston Scientific Electrode Lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
If you or a loved one was injured, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.