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RecallWatchMedical Device Safety
Class IIOngoingZ-0726-2026

Medtronic, Inc. recalls Aurora EV-ICD and Clinical EV-ICD

Medtronic, Inc.Mounds View, MN, United StatesReported Dec 10, 2025 · 7 months ago
Legal News Analyst ·

Reason for recall

There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4

Lot / code information

UDI
00763000368470, 00763000368463, 00763000217907, 00763000217891, 00763000288068, 00763000744694
Serial #
EVS600036S EVS600038S EVS600034S EVS600044S EVS600033S EVS600048S EVS600049S EVS600139S EVS600039S EVS600040S EVS600056S EVS600140S EVS600075S EVS600149S EVS600060S EVS600157S EVS600032S EVS600154S EV…Show all
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Additional code information

14S EVX604155S EVX604890S EVX607082S EVX607627S EVX605249S EVX605297S EVX606337S EVX606459S EVX607630S EVX607631S EVX607636S EVX604787S EVX607633S EVX607634S EVX607635S EVX607637S EVX607639S EVX607640S EVX606568S EVX607653S EVX607654S EVX605168S EVX607666S EVX606005S EVX600447S EVX602029S EVX602100S EVX602624S EVX603268S EVX604443S EVX604683S EVX604775S EVX607497S EVX607665S EVX600433S EVX600474S EVX600475S EVX600476S EVX600477S EVX601755S EVX604554S EVX605346S EVX605348S EVX605391S EVX604488S EVX604720S EVX604899S EVX605159S EVX600322S EVX600321S EVX600323S EVX600326S EVX600327S EVX600330S EVX600331S EVX600332S EVX600333S EVX600328S EVX600334S EVX600329S EVX600325S EVX600318S EVX600319S EVX600339S EVX600342S EVX600344S EVX600340S EVX600341S EVX600345S EVX600346S EVX600347S EVX600352S EVX600353S EVX600354S EVX600361S EVX600380S EVX600349S EVX600350S EVX600351S EVX600366S EVX600367S EVX600368S EVX600369S EVX600365S EVX600374S EVX600375S EVX600376S EVX600379S EVX600336S EVX600337S 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What the firm is doing

An URGENT MEDICAL DEVICE CORRECTION notification letter dated October 2025 was sent to customers. PATIENT MANAGEMENT RECOMMENDATIONS FOR PREVIOUSLY DISTRIBUTED DEVICES: Medtronic acknowledges that each patient requires unique clinical considerations. Based on internal investigation and consultation with our Independent Physician Quality Panel, Medtronic provides the following guidance: "Prophylactic device replacement is NOT recommended. "Schedule an in-clinic SmartSync interrogation to receive the software update, with the intent for all patients to receive theupdate within the next 3-6 months. For patients remotely followed via CareLink, your Medtronic representative can provide a report to assist with identifying patients that require this in-person update. You may contact your local representative to obtain an updated copy of the report at any time. CUSTOMER ACTIONS: "Ensure your SmartSync application is updated to include the Aurora EV-ICD Application. Contact your Medtronic representative if assistance is needed. "Please complete the enclosed Confirmation Form, following review of this letter, and email toRS.FCACRM@medtronic.com to confirm receipt of this notification. "Please forward this notice to everyone within your organization who needs to be aware and to locations where thesedevices could be followed if they are outside of your organization. If you have questions regarding this communication, please contact your Medtronic Representative.

DistributionShow details

Worldwide - US Nationwide distribution.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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