VALIANT® Captivia VAMC2824C150TU (UDI 00643169346666)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169346666), received between Feb 9, 2017 and Sep 15, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE INVOLVING THE STENT GRAFT VAMC2824C150TU VALCAP TAPER, THE DEVICE WOULD NOT FLUSH AND WAS LEAKING OUT OF THE BACK. THE PATIENT WAS TREATED FOR AN ULCER. A NEW GRAFT WAS OPENED AND USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23052333 ↗
• MalfunctionJun 26, 2024Leak/Splash; Leak/Splash

  VVALIANT CAPTIVIA STENT GRAFTS X4 WERE IMPLANTED DURING AN UNKNOWN PROCEDURE. APPROXIMATLEY 6 YEARS LATER, A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN TAA. IT WAS REPORTED CORE LAB REVIEW OF CT IMAGING FROM APPROXIMATELY 4 YEARS POST THE NAVION IMPLANT SHOWED A IB ENDOLEAK ON VNMC2828C90TU (B)(6). NO STENT FRACTURE, STENT RING ENLARGEMENT OR STENT RING MIGRATION WAS OBSERVED. THE MAXIMUM AORTIC DIAMETER WAS NOTED AS 59.5MM. DEVICE ORDER ON IMAGING WAS NOT CONFIRMED. A NON NAVION TYPE IA ENDOLEAK WAS OBSERVED PROXIMALLY. THE CAUSE OF THE ENDOEAKS ARE UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19615649 ↗
• InjuryFeb 9, 2017Occlusion Within Device; Occlusion Within Device

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5 CM IN DIAMETER ULCER IN THE DESCENDING THORACIC AORTA. THE THORACIC AORTA WAS NON-TORTUOUS. TWO VALIANT STENT GRAFTS WERE DEPLOYED WITHOUT ISSUE. PRIOR TO THE DELIVERY OF THE THIRD VALIANT STENT GRAFT, THE GUIDEWIRE POSITIONING WAS LOST AND THEN REPOSITIONED. IT WAS REPORTED THAT AFTER THE THIRD DISTAL VALIANT STENT GRAFT WAS DEPLOYED THE TOP 1/3RD PORTION ON ONE SIDE OF THE STENT GRAFT APPEARED TO BE MAL-DEFORMED/INFOLDED/CRUSHED AND NOT FULLY OPPOSED AGAINST THE OTHER STENT GRAFT OR VESSEL WALL. AFTER STENT GRAFT DEPLOYMENT, THERE WAS A PRESSURE GRADIENT BETWEEN THE THORACIC AREA AND THE FEMORAL ARTERY AREA WAS MORE THAN 100 MM OF MERCURY DUE TO STENOSIS/THROMBOSIS FORMATION. THE PHYSICIAN ELECTED TO PERFORM AN AXILLO-BI-FEMORAL BYPASS. THE BLOOD FLOW WAS RESTORED. THE PHYSICIAN STATED THE CAUSE OF THE EVENT IS RELATED TO THE STENT GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Occlusion

  MAUDE report 6317954 ↗