VALIANT® Captivia VAMC3838C150TU (UDI 00613994797315)Recalls & reported problems
Medtronic, Inc. · STENT GRAFT VAMC3838C150TU VALCAP CLOSE · Class 3 · Implant
All models of VALIANT Captivia (95)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994797315), received between May 25, 2017 and May 25, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Leak/Splash” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 25, 2017Leak/Splash; Leak/Splash
A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT CT IMAGING REVEALED THAT THE DISTAL END OF THE STENT GRAFT WAS FLOATING IN THE ANEURYSM. ANOTHER VALIANT STENT GRAFT WAS IMPLANTED DOWN TO THE LEVEL OF THE CELIAC ARTERY. THIS REPORTEDLY RESOLVED THE EVENT. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS DUE TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.
Patient problems: Injury
MAUDE report 6592989 ↗
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- Endurant® II ETCF2828C49EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls7 deaths44 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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