Quick Facts at a Glance
- Recall Date
- October 29, 2025
- Hazard Level
- HIGH
- Brand
- Medtronic
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Medtronic
- Product type
- Extravascular single-chamber implantable cardioverter defibrillator (ICD)
- Model numbers
- DVEA3E4, UDI-DI: 00763000368470, 00763000368463
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 29, 2025
Reported by FDA DEVICE
December 10, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
What You Should Do
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
About This Product
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.
Why This Is Dangerous
Delays in delivering high-voltage therapy could allow a dangerous arrhythmia to progress. This may reduce the effectiveness of treatment.
Industry Context
This recall is not described as part of a broader industry-wide pattern.
Real-World Impact
Patients with affected devices face urgent safety considerations and potential medical complications. Replacement or monitoring arrangements will be determined via the recall process.
Practical Guidance
How to identify if yours is affected
- Look for Product Number DVEA3E4 on the device label or accompanying documentation.
- Review UDI-DI numbers listed in the recall materials: 00763000368470 and 00763000368463.
- Compare serial numbers against the provided list in the recall materials.
Where to find product info
Recall notices, serial number ranges, and guidance are available through Medtronic and the FDA recall page linked in the notice.
What timeline to expect
Remediation typically occurs within weeks to months, depending on device availability and clinical reassessment.
If the manufacturer is unresponsive
- Escalate to your healthcare provider immediately.
- If the provider is unresponsive, contact Medtronic recall support and report concerns to the FDA.
How to prevent similar issues
- Regularly check for recall notices related to implanted devices.
- Maintain up-to-date medical records with device details (model, serial, UDI).
- Discuss with your clinician about monitoring plans and potential device replacement options.
Documentation advice
Keep the recall letter, medical records showing device implantation, serial numbers, and all communications with healthcare providers and Medtronic.
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Product Details
Aurora EV-ICD and Clinical EV-ICD single-chamber extravascular ICDs. Product Number DVEA3E4. 6,591 units recalled. Worldwide distribution, including US nationwide.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Product Number DVEA3E4
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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