Class II U.S. Food and Drug Administration

Medtronic, Inc. Aurora EV-ICD and Clinical EV-ICD, single chamber recall: There is a potential for delayed time to high-voltage (HV) therapy

Recall published 11 months ago

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

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

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

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0726-2026
Published
December 10, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medtronic, Inc.
Product type
Medical devices
Units affected
6591 units
Distribution
Nationwide
Made in
United States
Lot / code info
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 EVS600522S EVS600093S EVS600532S EVS600557S EVS600558S EVS600560S EVS600542S EVS600577S EVS600088S EVS600337S EVS600338S EVS600339S EVS600089S EVS600568S EVS600092S EVS600579S EVS600090S EVS600547S EVS600576S EVS600616S EVS600556S EVS600559S EVS600258S EVS600259S EVS600310S EVS600312S EVS600517S EVS600623S EVS600319S EVS600618S EVS600336S EVS600311S EVS600334S EVS600498S EVS600341S EVS600352S EVS600491S EVS600492S EVS600494S EVS600342S EVS600489S EVS600567S EVS600611S EVS600099S EVS600268S EVS600501S EVS600100S EVS600265S EVS600269S EVS600270S EVS600320S EVS600549S EVS600550S EVS600619S EVS600620S EVS600633S EVS600635S EVS600551S EVS600288S EVS600569S EVS600570S EVS600638S EVS600639S EVS600640S EVS600505S EVS600518S EVS600561S EVS600566S EVS600629S EVS600555S EVS600534S EVS600578S EVS600580S EVS600720S EVS600699S EVS600700S EVS600701S EVS600702S EVS600704S EVS600705S EVS600706S EVS600707S EVS600708S EVS600709S EVS600710S EVS600711S EVS600712S EVS600715S EVX600203S EVX600204S EVX600205S EVX600199S EVX600195S EVX600250S EVX600246S EVX600197S EVX600251S EVX600255S EVX600257S EVX600230S EVX600253S EVX600256S EVX600258S EVX600264S EVX600277S EVX600278S EVX600297S EVX600307S EVX6002…
UPC codes
00763000368470, 00763000368463, 00763000217907, 00763000217891, 00763000288068, 00763000744694

Products covered by this recall

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

Check your product

The notice names 8 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00763000368470
  • 00763000368463
  • 00763000217907
  • 00763000217891
  • 00763000288068
  • 00763000744694

Model or item number

On the rating label, the box or the instruction sheet.

  • DVEA3E4 — UDI-DI

Serial number

On the rating plate, often next to the date of manufacture.

  • EVS600036S EVS600038S EVS600034S EVS60004

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Medtronic, Inc. — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Medtronic, Inc. — 8200 Coral Sea St Ne, Mounds View, MN, 55112-4391

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medtronic, Inc. medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00763000368470, 00763000368463, 00763000217907; model number DVEA3E4 — UDI-DI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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