Medtronic recalled 6,591 Aurora EV-ICD and Clinical EV-ICD single-chamber extravascular implantable defibrillators worldwide. A rare sequence of events could delay high-voltage therapy. Patients and healthcare providers should stop using the device immediately and follow the recall instructions.
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medtronic, Inc. or your healthcare provider for instructions. Notification method: Letter
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The Aurora EV-ICD and Clinical EV-ICD are single-chamber extravascular implantable defibrillators used to treat life-threatening arrhythmias. They are implanted under medical supervision and require ongoing physician follow-up.
Delays in delivering high-voltage therapy could allow a dangerous arrhythmia to progress. This may reduce the effectiveness of treatment.
This recall is not described as part of a broader industry-wide pattern.
Patients with affected devices face urgent safety considerations and potential medical complications. Replacement or monitoring arrangements will be determined via the recall process.
Recall notices, serial number ranges, and guidance are available through Medtronic and the FDA recall page linked in the notice.
Remediation typically occurs within weeks to months, depending on device availability and clinical reassessment.
Keep the recall letter, medical records showing device implantation, serial numbers, and all communications with healthcare providers and Medtronic.
Aurora EV-ICD and Clinical EV-ICD single-chamber extravascular ICDs. Product Number DVEA3E4. 6,591 units recalled. Worldwide distribution, including US nationwide.
No injuries or incidents have been reported.
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