VALIANT® Captivia VAMC4242B100TURecalls & reported problems
Medtronic, Inc. · STENT GRAFT VAMC4242B100TU VALCAP BARE · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169347274), received between Dec 14, 2023 and Dec 14, 2023 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 14, 2023Leak/Splash; Leak/Splash
A VALIANT CAPTIVIA STENT GRAFT VAMF4040C100TU (B)(6) WAS IMPLANTED WITH AN ENDURANT IIS STENT GRAFT SYSTEM DURING THE ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL ANEURYSM. 3 ADDITIONAL VALIANT STENT GRAFTS WERE FURTHER IMPLANTED 4 MONTHS LATER. IT WAS REPORTED APPROXIMATLEY 5 YEARS POST THE INDEX PROCEDURE, FOLLOW UP CT IDENTIFED A TYPE IA AND TYPE IB ENDOLEAK FROM THE PREVIOUS TEVAR GRAFTS. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAKS ARE UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT WILL BE MONITORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18324436 ↗
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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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