Boston Scientific EMBLEM S-ICD Subcutaneous Electrode (Model 3501) Lawsuits
The Food and Drug Administration (FDA) has announced a Class I recall of the Boston Scientific EMBLEM S-ICD Subcutaneous Electrode (Model 3501) due to the risk of fracture, which would hinder delivery of therapy to the patient. The Boston Scientific EMBLEM S-ICD is a cardioverter defibrillator that is used to supply electrical shocks to the heart. The device is implanted under the skin in the upper chest in patients who have dangerously rapid heart rhythms.
Boston Scientific EMBLEM S-ICD Subcutaneous Electrode (Model 3501) Lawyers are Ready to Help
Contact our Boston Scientific EMBLEM S-ICD Subcutaneous Electrode Lawyers to review whether you or a family member may be entitled to financial compensation. Levy Konigsberg LLP is currently accepting Boston Scientific EMBLEM S-ICD Subcutaneous Electrode cases in all 50 states.
If you or a loved one has suffered one or more of these complications, you may be entitled to a cash award and compensation for medical expenses. For a free confidential consultation with Boston Scientific EMBLEM S-ICD Subcutaneous Electrode Lawyers at our law firm, please call 1-800-988-8005 or submit an email inquiry above.
What is Boston Scientific EMBLEM S-ICD Subcutaneous Electrode?
The Boston Scientific EMBLEM S-ICD Subcutaneous Electrode is prescribed for the management of cardiac arrythmia. The device is inserted into the chest in order to deliver therapy to slow down abnormally fast heartbeats. If the device malfunctions, the patient faces increased risk of tachycardia.
What is Happening with Boston Scientific EMBLEM S-ICD Subcutaneous Electrode?
The FDA has recently issued its most serious recall in connection with the Boston Scientific EMBLEM S-ICD Subcutaneous Electrode. The recall affects all devices distributed after June 2017. The FDA’s alert concerns the possibility of a fracture to the proximal sense ring. If the device breaks, the electrode would fail to provide defibrillation therapy to the patient, and thereby increase the possibility of a catastrophic cardiac event. There have been 26 reports of serious injury and one report of death linked to malfunctioning of the device.
The manufacturer issued a letter to affected customers in December 2020 to identify devices that were prone to malfunctioning. Medical professionals were advised to weigh the risks of replacing the device vs. using affected devices. The FDA provided medical professionals with a detailed plan for caring for and monitoring patients with devices that might be at risk for fracturing.
Boston Scientific EMBLEM S-ICD Subcutaneous Electrode Side Effects and Complications
Complications of a fracture of the Boston Scientific EMBLEM S-ICD Subcutaneous Electrode include:
- Cardiac arrest;
- Brain injury;
- Cardiovascular injury, including heart attack and stroke; and
- Death.
Boston Scientific EMBLEM S-ICD Subcutaneous Electrode Lawyers are Ready to Help
Contact our Boston Scientific EMBLEM S-ICD Subcutaneous Electrode Lawyers to review whether you or a family member may be entitled to financial compensation. Levy Konigsberg LLP is currently accepting Boston Scientific EMBLEM S-ICD Subcutaneous Electrode cases in all 50 states.
If you or a loved one has suffered one or more of these complications, you may be entitled to a cash award and compensation for medical expenses. For a free confidential consultation with Boston Scientific EMBLEM S-ICD Subcutaneous Electrode Lawyers at our law firm, please call 1-800-988-8005 or submit an email inquiry above.
