VALIANT® Captivia VAMF3232C150TU (UDI 00613994797704)Recalls & reported problems
Medtronic, Inc. · STENT GRAFT VAMF3232C150TU VALCAP FREFL · 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 00613994797704), received between Mar 31, 2017 and Mar 31, 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
- Migration or Expulsion of Device1
Patient problems
- Injury1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 31, 2017Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device
ADDITIONAL INFORMATION RECEIVED. THE PHYSICIAN ELECTED TO IMPLANT AN ADDITIONAL VALIANT DEVICE AND EXTENDED COVERAGE UP TO THE ORIGIN OF THE LEFT COMMON CAROTID ARTERY. THE EVENT WAS RESOLVED AFTER THE INTERVENTION WAS PERFORMED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS UNKNOWN.
Patient problems: Injury; No Consequences Or Impact To Patient
MAUDE report 6451001 ↗
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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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