Lower riskMedical device recall · FDA · Published February 12, 2021
Medtronic Vascular recalls Valiant Navion Thoracic Stent Graft System due to endoleaks
Medtronic Vascular recalls Valiant Navion Thoracic Stent Graft System (models VNMC2020C94TE, VNMC2020C94TJ, etc.) for endoleaks, stent fractures, and stent ring enlargement. Affected patients should contact Medtronic for evaluation.
Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement.
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Contact the company
📍Recalling firmMedtronic Vascular, Inc.3850 Brickway Blvd · Santa Rosa, CA 95403-8223
✎ GovInfoNow plain-language explainer
Medtronic is recalling its Valiant Navion Thoracic Stent Graft System for endovascular repair of descending thoracic aorta lesions. The recall is due to type IIIb endoleaks, stent fractures, and stent ring enlargement. Patients with the affected models should contact Medtronic for evaluation. Read more at govinfonow.com/recall/63271-medtronic-vascular-recalls-valiant-navion-thoracic-stent-graft-system-due.
“Medtronic Vascular recalls Valiant Navion Thoracic Stent Graft System due to endoleaks.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63271-medtronic-vascular-recalls-valiant-navion-thoracic-stent-graft-system-due. Based on FDA recall #Z-1201-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1201-2021%22&limit=1).
The FDA has issued a Class I recall for the Valiant Navion Thoracic Stent Graft System due to safety risks associated with the device used for endovascular repair of lesions in the descending thoracic aorta.
How to tell if you have it
Valiant Navion Thoracic Stent Graft System
Medtronic Vascular, Inc.
The hazard
The provided text does not specify the exact hazard or defect causing this Class I recall, only listing it as 'Class I' and 'Ongoing'.
Context
Medtronic Vascular, Inc. has 6 other recalls on record since 2017-09-13. Other recent thoracic aortic device recalls include the Bolton Medical RelayPro Thoracic Stent-Graft System (2026-04-22) and INSPIREMD CGuard Prime Carotid Stent System (2026-05-01).
How to tell if you have this one
Check for model numbers starting with VNMC or VNMF followed by specific codes (e.g., VNMC2020C94TE, VNMF2020C96TE). Also check the GTIN numbers listed in the recall. Serial numbers are provided in the recall.
Brand
Trsmima
Product
Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA)
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Model
Review the model number on the device packaging or label to see if it matches the recalled models listed in the recall.
Contact Medtronic
Reach out to Medtronic directly for evaluation and guidance on next steps if the device is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 33 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1201-2021 (February 12, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1201-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.