Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators…
Medical device recall Z-0726-2026. Published in FDA’s Enforcement Report on Dec 10, 2025.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 10, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 6591 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
6591 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: 00763000368470, 00763000368463, 00763000217907, 00763000217891, 00763000288068, 00763000744694; Serial Numbers: EVS600036S EVS600038S EVS600034S EVS600044S EVS600033S EVS600048S EVS600049S EVS600139S EVS600039S EVS600040S…
Every code shown here, 1,990 characters
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…
FDA’s list runs to 72,622 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide - US Nationwide distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 29, 2025.
- FDA classified it on Nov 28, 2025.
- FDA’s Enforcement Report published it on Dec 10, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic, Inc., of Mounds View, MN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 72,622 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.