Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems
Medical device recall Z-1543-2017. Published in FDA’s Enforcement Report on Mar 29, 2017.
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 Mar 29, 2017. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Puerto Rico the one state its words name
- 3331 devices 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?
Medtronic is initiating a voluntary Urgent Medical Device Recall for a subset of Endurant/ Endurant II Bifurcated Stent Graft Systems of specific models and serial numbers as this specific subset of stent grafts has greater susceptibility to fabric permeability variations that may be associated with endoleaks observed during the initial implant procedure.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ETBF2516C166E ETBF2316C145E ETBF2313C145E ETBF2513C166E ETBF2313C166E ETBF2316C166E ETBF2313C124E ETBF2513C145E ETBF2516C124E ETBF2316C124E ETBF2513C124E. Cardiology: The Endurant family of stent graft systems is Intended to treat infra-renal abdominal aortic or aortoiliac aneurysms using an endovascular approach. When placed within the aneurysm, the stent graft provides an alternative conduit for blood flow within the patient’s vasculature.
3331 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product UPN/GTIN Serial number 00613994992048 V05884896 00643169215849 V05981026 00643169215849 V05981027 00643169215849 V05981030 00643169215849 V05981031 00643169215849 V05981032 00643169215849 V05981033 00643169215849 V05981034…
Every code shown here, 1,996 characters
Product UPN/GTIN Serial number 00613994992048 V05884896 00643169215849 V05981026 00643169215849 V05981027 00643169215849 V05981030 00643169215849 V05981031 00643169215849 V05981032 00643169215849 V05981033 00643169215849 V05981034 00643169215849 V05981035 00613994992024 V05981039 00613994992024 V05981040 00613994992024 V05981044 00613994992024 V05981045 00643169215856 V05981415 00643169215856 V05981416 00643169215856 V05981417 00643169215856 V05981418 00643169215856 V05981419 00643169215856 V05981420 00643169215856 V05981421 00643169215856 V05981422 00643169215856 V05981423 00643169215856 V05981424 00613994991263 V05981721 00613994991263 V05981722 00613994991263 V05981723 00613994991263 V05981724 00613994991263 V05981725 00613994991263 V05981726 00613994991263 V05981728 00643169215795 V05982579 00643169215795 V05982581 00643169215795 V05982584 00643169215795 V05982586 00613994992048 V05983552 00613994992048 V05983556 00613994992048 V05983558 00613994991980 V05984180 00613994991980 V05984181 00613994991980 V05984182 00613994991980 V05984183 00613994991980 V05984184 00613994991980 V05984185 00613994991980 V05984186 00613994991980 V05984187 00613994991980 V05984188 00613994991980 V05984189 00613994992031 V05985031 00613994992048 V05985511 00613994992048 V05985512 00613994992048 V05985513 00613994992048 V05985514 00613994992048 V05985515 00613994992048 V05985516 00613994992048 V05985517 00613994992048 V05985518 00613994992048 V05985519 00613994992048 V05985520 00613994992048 V05985521 00613994992048 V05985522 00613994992048 V05985523 00613994992048 V05985524 00613994992048 V05985525 00613994992048 V05985526 00613994992048 V05985527 00613994992048 V05985528 00613994992048 V05985529 00613994992048 V05985530 00613994644268 V05986025 00613994644268 V05986033 00643169215856 V05986324 00643169215856 V05986325 00643169215856 V05986326 00643169215856 V05986327 00643169215856 V05986328 00643169215856 V05986329 00643169215856 V05986330 00643169215856 V05986331 00643169215856…
FDA’s list runs to 100,415 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 Distribution - US Distribution including Puerto Rico and to the countries of : Argentina Armenia Australia Austria Belgium Brazil Bulgaria Canada China Colombia Costa Rica Croatia Cyprus Czech Republic Denmark Dominican Republic Ecuador Egypt El Salvador Finland France French Polynesia Germany Greece Hong Kong Hungary Iceland India Indonesia Iran Ireland Israel Italy Japan Jordan Kazakhstan Korea Kuwait Latvia Lebanon Lithuania Luxembourg Malaysia Mexico Montenegro Netherlands New Zealand Norway Oman Panama Paraguay Peru Philippines Poland Portugal Reunion Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Sweden Switzerland Taiwan Thailand Turkey United Arab Emirates United Kingdom Uruguay Venezuela Viet Nam
The states and territories these words name
- Puerto Rico
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 Feb 27, 2017.
- FDA classified it on Mar 23, 2017.
- FDA’s Enforcement Report published it on Mar 29, 2017.
- FDA terminated it on Mar 1, 2018.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic Vascular, Inc., of Santa Rosa, CA.
- 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 100,415 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.