Valiant Navion Thoracic Stent Graft System
Medical device recall Z-1201-2021. Published in FDA’s Enforcement Report on Mar 17, 2021.
- FDA Class I
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 17, 2021. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 33,430 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 I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA).
33,430 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Number (REF): VNMC2020C94TE VNMC2020C94TJ VNMC2020C94TU VNMC2222C180TE VNMC2222C180TJ VNMC2222C180TU VNMC2222C94TE VNMC2222C94TJ VNMC2222C94TU VNMC2520C186TE VNMC2520C186TJ VNMC2520C186TU VNMC2525C180TE VNMC2525C180TJ VNMC2525C180TU…
Every code shown here, 1,992 characters
Model Number (REF): VNMC2020C94TE VNMC2020C94TJ VNMC2020C94TU VNMC2222C180TE VNMC2222C180TJ VNMC2222C180TU VNMC2222C94TE VNMC2222C94TJ VNMC2222C94TU VNMC2520C186TE VNMC2520C186TJ VNMC2520C186TU VNMC2525C180TE VNMC2525C180TJ VNMC2525C180TU VNMC2525C94TE VNMC2525C94TJ VNMC2525C94TU VNMC2822C207TE VNMC2822C207TJ VNMC2822C207TU VNMC2828C182TE VNMC2828C182TJ VNMC2828C182TU VNMC2828C90TE VNMC2828C90TJ VNMC2828C90TU VNMC3125C207TE VNMC3125C207TJ VNMC3125C207TU VNMC3131C182TE VNMC3131C182TJ VNMC3131C182TU VNMC3131C223TE VNMC3131C223TJ VNMC3131C223TU VNMC3131C90TE VNMC3131C90TJ VNMC3131C90TU VNMC3428C207TE VNMC3428C207TJ VNMC3428C207TU VNMC3434C182TE VNMC3434C182TJ VNMC3434C182TU VNMC3434C223TE VNMC3434C223TJ VNMC3434C223TU VNMC3434C52TE VNMC3434C52TJ VNMC3434C52TU VNMC3434C90TE VNMC3434C90TJ VNMC3434C90TU VNMC3731C207TE VNMC3731C207TJ VNMC3731C207TU VNMC3737C182TE VNMC3737C182TJ VNMC3737C182TU VNMC3737C223TE VNMC3737C223TJ VNMC3737C223TU VNMC3737C52TE VNMC3737C52TJ VNMC3737C52TU VNMC3737C90TE VNMC3737C90TJ VNMC3737C90TU VNMC4034C200TE VNMC4034C200TJ VNMC4034C200TU VNMC4040C175TE VNMC4040C175TJ VNMC4040C175TU VNMC4040C218TE VNMC4040C218TJ VNMC4040C218TU VNMC4040C55TE VNMC4040C55TJ VNMC4040C55TU VNMC4040C95TE VNMC4040C95TJ VNMC4040C95TU VNMC4337C200TE VNMC4337C200TJ VNMC4337C200TU VNMC4343C175TE VNMC4343C175TJ VNMC4343C175TU VNMC4343C218TE VNMC4343C218TJ VNMC4343C218TU VNMC4343C55TE VNMC4343C55TJ VNMC4343C55TU VNMC4343C95TE VNMC4343C95TJ VNMC4343C95TU VNMC4640C200TE VNMC4640C200TJ VNMC4640C200TU VNMC4646C175TE VNMC4646C175TJ VNMC4646C175TU VNMC4646C218TE VNMC4646C218TJ VNMC4646C218TU VNMC4646C55TE VNMC4646C55TJ VNMC4646C55TU VNMC4646C95TE VNMC4646C95TJ VNMC4646C95TU VNMF2020C96TE VNMF2020C96TU VNMF2222C185TE VNMF2222C185TU VNMF2222C96TE VNMF2222C96TJ VNMF2222C96TU VNMF2520C185TE VNMF2520C185TJ VNMF2520C185TU VNMF2525C185TE VNMF2525C185TJ VNMF2525C185TU VNMF2525C96TE VNMF2525C96TJ VNMF2525C96TU VNMF2822C173TE VNMF2822C173TJ VNMF2822C173TU VNMF2828C174TE VNMF2828C174TJ…
FDA’s list runs to 374,646 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 Nationwide, Italy, Denmark, Germany, Finland, Chile, Russian Federation, Norway, South Africa, New Zealand, Australia, United Kingdom, Switzerland, Austria, Netherlands, Spain, Portugal, France, Israel, Greece, Thailand, Ireland, Colombia, Canada, Hong Kong, Sweden, Belgium, Saudi Arabia, Malaysia, Singapore, Brazil, Macau, Luxembourg, Viet Nam, Taiwan, Croatia, Serbia, United Arab Emirates, Slovenia, Philippines, Poland, Japan, Costa Rica, Hungary, Korea, Slovakia, Malta, Bahrain, Kuwait, Qatar, Reunion, Honduras, Mauritius, India, Peru, El Salvador, Ukraine, Uruguay, Trinidad and Tobago.
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 Feb 12, 2021.
- FDA classified it on Mar 10, 2021.
- FDA’s Enforcement Report published it on Mar 17, 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 374,646 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.