Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF…
Medical device recall Z-0291-2022. Published in FDA’s Enforcement Report on Dec 1, 2021.
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 1, 2021. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 16 states named
- 511 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?
Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETCF2828C49EE STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETCF2828C49EE STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETCF2828C49EE STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETBF2313C124EE STENT GRAFT ETBF2313C124EE ENDUR II BIF ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2516C166EE STENT GRAFT ETBF2516C166EE ENDUR II BIF ETBF2516C166EE STENT GRAFT ETBF2516C166EE ENDUR II BIF ETBF2516C166EE STENT GRAFT ETBF2516C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETUF2514C102E STENT GRAFT ETUF2514C102E ENDUR II AUI ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETCF2525C49E STENT GRAFT ETCF2525C49E ENDUR II AOEXT ETCF2828C49E STENT GRAFT ETCF2828C49E ENDUR II AOEXT ETCF2828C49E STENT GRAFT ETCF2828C49E ENDUR II AOEXT ETCF2828C49E STENT GRAFT ETCF2828C49E ENDUR II AOEXT ETUF2814C102E STENT GRAFT ETUF2814C102E ENDUR II AUI ETUF2814C102E STENT GRAFT ETUF2814C102E ENDUR II AUI ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETBF2313C166EE STENT GRAFT ETBF2313C166EE ENDUR II BIF ETBF2513C124EE STENT GRAFT ETBF2513C124EE ENDUR II BIF ET
511 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Number/GTIN Code/Product Description: ETBF2513C145EE 00643169781047 V30584649 STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE 00643169781177 V30593589 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE 00643169781177…
Every code shown here, 1,991 characters
Model Number/GTIN Code/Product Description: ETBF2513C145EE 00643169781047 V30584649 STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE 00643169781177 V30593589 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE 00643169781177 V30593590 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE 00643169781177 V30593591 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE 00643169781177 V30593592 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE 00643169781177 V30593593 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE 00643169781177 V30593594 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE 00643169781177 V30593595 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETCF2828C49EE 00643169780798 V30595328 STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETCF2828C49EE 00643169780798 V30595331 STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETCF2828C49EE 00643169780798 V30595332 STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETUF2514C102EE 00643169780934 V30595382 STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE 00643169780934 V30595383 STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE 00643169780934 V30595386 STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE 00643169780934 V30595389 STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE 00643169780934 V30595390 STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE 00643169780934 V30595391 STENT GRAFT ETUF2514C102EE ENDUR II AUI ETBF2313C124EE 00643169780972 V30595456 STENT GRAFT ETBF2313C124EE ENDUR II BIF ETBF2513C145EE 00643169781047 V30595505 STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE 00643169781047 V30595515 STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE 00643169781047 V30595516 STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE 00643169781047 V30595517 STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2516C166EE 00643169781085 V30596585 STENT GRAFT ETBF2516C166EE ENDUR II BIF ETBF2516C166EE 00643169781085 V30596586 STENT GRAFT ETBF2516C166EE ENDUR II BIF ETBF2516C166EE 00643169781085…
FDA’s list runs to 33,698 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 - U.S. Nationwide distribution in the states of CA, FL, GA, MN, MO, NC, NJ, NM, NV, NY, PA, SC, TN, TX, VA, and WV. The countries of Austria, Belgium, Bulgaria, China, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Japan, Jordan, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Qatar, South Africa, Spain, Sweden, Switzerland, and United Kingdom.
The states and territories these words name
16 states and territories.
Every one of them
- California
- Florida
- Georgia
- Minnesota
- Missouri
- North Carolina
- New Jersey
- New Mexico
- Nevada
- New York
- Pennsylvania
- South Carolina
- Tennessee
- Texas
- Virginia
- West Virginia
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 15, 2021.
- FDA classified it on Nov 24, 2021.
- FDA’s Enforcement Report published it on Dec 1, 2021.
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 33,698 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
-
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.