What’s the Problem?
According to the U.S. Food & Drug Administration (FDA), this recall affects:
- Boston Scientific EMBLEM S-ICD Subcutaneous Electrode Model Number 3501
This recall was issued after dozens of reports of fractures at a specific point (distal to the proximal sense ring). “If the device fractures during use, it could become unable to deliver therapy to slow very fast heartbeats from cardiac arrest (tachycardia),” FDA said.
The EMBLEM S-ICD Subcutaneous Electrode Model 3501 is part of the Boston Scientific S-ICD System, which is an implantable cardioverter defibrillator intended to provide pacing for slow heart rhythms and electrical shock or pacing to stop dangerously fast heart rhythms. Electrodes are implanted under the skin in the upper chest area.
A failed electrode may cause serious adverse events including injury or death if cardiac arrest cannot be treated or need for additional surgery to replace failed devices.
Those at the greatest risk for electrode fracture include:
- Patients who have a history of life-threatening ventricular arrhythmias such as secondary prevention
- Patients who are unable to be reliably followed remotely or in person every three months
- Patients who are not monitored via LATITUDE and are unable to hear beeping tones
This recall began on December 2, 2020.
Do I Have a Boston Scientific Electrode Lawsuit?
The Medical Device 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.