Skip to content

VALIANT® Captivia VAMF4040C200TU (UDI 00613994797988)Recalls & reported problems

Medtronic, Inc. · STENT GRAFT VAMF4040C200TU 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
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994797988), received between May 22, 2017 and May 22, 2017 — 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.

Most reported problems

Device problems

  • Leak/Splash1

Patient problems

  • 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.

  • MalfunctionMay 22, 2017Leak/Splash; Leak/Splash

    A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS SELECTED FOR THE ENDOVASCULAR TREATMENT OF A 6.6 CM IN DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT A RECENT CT REVEALED A PROXIMAL TYPE I ENDOLEAK. PER THE PHYSICIAN, THE CAUSE OF THE PROXIMAL TYPE I ENDOLEAK RELATED TO THE PATIENT¿S ANATOMY, DISEASED THORACIC AORTA MULTIPLE THORACIC AORTIC ANEURYSMS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THE PHYSICIAN.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6583375 ↗

Other SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT devices

All SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page