Food, drugs, devices › Medtronic Vascular, Inc.
Device recall: Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA).
FDA enforcement event 87379 is a device recall by Medtronic Vascular, Inc. of Santa Rosa, CA, initiated 12 Feb 2021 and classified Class I, with 1 product record.
FDA defines Class I as 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. 8% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Medtronic Vascular, Inc. has 13 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Medtronic Vascular, Inc., Santa Rosa, CA.
Reason for recall
"Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement."
Distribution
"Worldwide distribution. US Nationwide, Italy, Denmark, Germany, Finland, Chile, Russian Federation, Norway, South Africa, New Zealand, Australia, United Kingdom, Switzerland, Austria, Netherlands,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1201-2021 | Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA). | 33,430 units | Class I | Ongoing | 17 Mar 2021 |
Context
Other enforcement events for Medtronic Vascular, Inc.
All 13 events for Medtronic Vascular, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution. US Nationwide, Italy, Denmark, Germany, Finland, Chile, Russian Federation, Norway, South Africa, New Zealand, Australia, United Kingdom, Switzerland, Austria, Netherlands,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.