Medtronic recalled 6,591 extravascular implantable cardioverter defibrillators on October 29, 2025. The recall stems from a potential delay in high-voltage therapy that could occur under rare conditions. Patients must stop using the devices immediately and follow manufacturer 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 recall includes Aurora EV-ICD and Clinical EV-ICD models with product number DVEA3E4. These devices were distributed worldwide, including the US, and are priced approximately at $1,800.
There is a potential risk for a delayed response to high-voltage therapy during a cardiac event. This delay could prevent the defibrillator from functioning properly in critical situations.
As of now, no specific injuries or incidents have been reported related to this defect, but the risk of serious consequences is classified as high.
Patients should stop using the device immediately. Contact Medtronic or their healthcare provider for further instructions and potential return processes.
For assistance, patients can call Medtronic at 1-800-xxx-xxxx or visit their website at www.medtronic.com.
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