Medtronic, Inc. has issued a recall for 6,591 units of its Aurora EV-ICD and Clinical EV-ICD single chamber extravascular implantable cardioverter defibrillators, specifically Product Number DVEA3E4. These medical devices, manufactured in the United States, are being recalled due to a rare sequence of events that could result in a delayed delivery of high-voltage life-saving therapy. Patients with these specific serial numbers should not take physical action themselves but must consult their healthcare provider to discuss the potential for this delay and any necessary monitoring or device adjustments.
A rare internal sequence of events can lead to a delayed time to high-voltage (HV) therapy, potentially failing to stop a life-threatening heart rhythm in a timely manner. This delay in treatment for cardiac arrest or ventricular fibrillation could lead to serious injury or death if the device does not discharge when required.
Consultation and monitoring
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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