--- title: "Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable ... — FDA record Z-0726-2026 | Is It on Recall" description: "There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur." url: https://isitonrecall.com/recall/fda-device-z-0726-2026-aurora-ev-icd-and-clinical-ev-icd-single-chamber-extravascular-implantable-cardioverter-defibrillato/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Produ... — FDA record Z-0726-2026 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Oct 29, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4 - **Reason**: There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur. - **Classification**: Class II - **Recalling firm**: Medtronic, Inc. - **Quantity**: 6591 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-0726-2026 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0726-2026%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | UDI-DI: 00763000368470, 00763000368463, 00763000217907, 00763000217891, 00763000288068, 00763000744694; Serial Numbers: EVS600036S EVS600038S EVS600034S EVS600044S EVS600033S EVS600048S EVS600049S EVS600139S EVS600039S EVS600040S EVS600056S EVS600140S EVS600075S EVS600149S EVS600060S EVS600157S EVS600032S EVS600154S EVS600161S EVS600045S EVS600050S EVS600150S EVS600061S EVS600064S EVS600065S EVS600178S EVS600201S EVS600058S EVS600180S EVS600168S EVS600156S EVS600057S EVS600212S EVS600164S EVS600155S EVS600167S EVS600134S EVS600209S EVS600177S EVS600170S EVS600055S EVS600220S EVS600236S EVS600141S EVS600166S EVS600254S EVS600211S EVS600234S EVS600142S EVS600357S EVS600353S EVS600210S EVS600354S EVS600218S EVS600364S EVS600348S EVS600374S EVS600369S EVS600384S EVS600343S EVS600207S EVS600371S EVS600389S EVS600053S EVS600135S EVS600367S EVS600206S EVS600349S EVS600344S EVS600408S EVS600365S EVS600407S EVS600052S EVS600203S EVS600350S EVS600411S EVS600412S EVS600051S EVS600397S EVS600400S EVS600423S EVS600165S EVS600390S EVS600351S EVS600370S EVS600641S EVS600368S EVS600216S EVS600382S EVS600199S EVS600208S EVS600399S EVS600380S EVS600221S EVS600415S EVS600073S EVS600205S EVS600159S EVS600239S EVS600179S EVS600642S EVS600671S EVS600646S EVS600648S EVS600658S EVS600660S EVS600649S EVS600651S EVS600669S EVS600657S EVS600643S EVS600672S EVS600670S EVS600681S EVS600680S EVS600676S EVS600683S EVS600679S EVS600673S EVS600686S EVS600653S EVS600654S EVS600665S EVS600741S EVS600743S EVS600745S EVS600153S EVS600650S EVS600663S EVS600656S EVS600666S EVS600675S EVS600281S EVS600095S EVS600096S EVS600011S EVS600097S EVS600255S EVS600074S EVS600085S EVS600247S EVS600252S EVS600094S EVS600086S EVS600266S EVS600267S EVS600502S EVS600314S EVS600277S EVS600303S EVS600304S EVS600305S EVS600272S EVS600273S EVS600012S EVS600013S EVS600015S EVS600016S EVS600027S EVS600315S EVS600313S EVS600316S EVS600317S EVS600318S EVS600571S EVS600572S EVS600307S EVS600308S EVS600573S EVS600575S EVS600612S EVS600614S EVS600014S EVS600028S EVS600071S EVS600078S EVS600098S EVS600248S EVS600251S EVS600306S EVS600327S EVS600271S EVS600069S EVS600332S EVS600378S EVS600381S EVS600375S EVS600376S EVS600377S EVS600393S EVS600418S EVS600246S EVS600420S EVS600421S EVS600324S EVS600325S EVS600482S EVS600483S EVS600484S EVS600488S EVS600322S EVS600263S EVS600335S EVS600340S EVS600373S EVS600485S EVS600496S EVS600256S EVS600500S EVS600543S EVS600553S EVS600481S EVS600487S EVS600630S EVS600631S EVS600329S EVS600510S EVS600503S EVS600529S EVS600513S EVS600385S EVS600524S EVS600525S EVS600526S EVS600262S EVS600486S EVS600326S EVS600495S EVS600530S EVS600527S EVS600511S EVS600520S EVS600554S EVS600548S EVS600512S EVS600521S EVS600504S EVS600531S EVS600541S EVS600591S EVS600597S EVS600598S EVS600507S EVS600600S 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EVX602886S EVX603059S EVX601440S EVX601950S EVX601951S EVX601966S EVX602881S EVX602949S EVX603274S EVX603284S EVX603285S EVX603286S EVX603287S EVX603288S EVX601831S EVX602704S EVX60329... | The agency lot list is longer than this excerpt. [Read the complete list at the official source](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0726-2026%22). Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution Worldwide - US Nationwide distribution. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Dec 10, 2025 - **Recall initiation date**: Oct 29, 2025 - **Center classification date**: Nov 28, 2025 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0726-2026%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Medtronic Inc records](https://isitonrecall.com/brand/medtronic-inc/)