Avalus Ultra™ 400U29Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000647070), received between Apr 28, 2025 and Nov 7, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 16, 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.

• InjuryNov 7, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT THE SAME DAY POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, IT WAS REPORTED THAT BLEEDING OCCURRED. THE PATIENT HAD ELEVATED CHEST TUBE OUTPUT, AND WAS BROUGHT BACK TO THE OPERATING ROOM FOR EXPLORATION. IT WAS FURTHER NOTED THAT THERE WERE TWO SEPARATE SITES OF BLEEDING FROM THE PROXIMAL SUTURE LINE AND DISTAL SUTURE LINE. TREATMENT FOR THE BLEEDING WAS PERFORMED. THE PATIENTS HOSPITALIZATION WAS PROLONGED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23499831 ↗
• InjuryMay 27, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, THE SURGEON SIZED THE VALVE USING ONLY THE BARREL E ND OF THE VALVE SIZER AND WAS "ABLE TO GET THE VALVE SEATED BUT THE LEFT CORONARY WAS LOW/CLOSE TO THE ANNULUS AND THE VALVE WAS PARTIALLY OBSTRUCTING". IT WAS REPORTED THAT THE VALVE WAS EXPLANTED DUE TO THE VALVE BEING OVERSIZED. IT WAS STATED THAT THE AORTIC VALVE WAS RE-SIZED USING BOTH THE BARREL AND REPLICA END OF THE VALVE SIZER AND IT WAS DECIDED THAT A 27MM VALVE WOULD FIT BETTER AND ALLOW FOR BETTER CORONARY CLEARANCE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22086622 ↗
• InjuryApr 28, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE IMPLANTED IN THE MITRAL POSITION, IT WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURERS PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS AFTER SEWING THE VALVE IN, THE VALVE WAS TOO BIG, AND MAY HAVE AFFECTED THE SMALL OUTFLOW TRACT. IT WAS FURTHER REPORTED THAT THE PATIENT HAD VERY THICKENED CHORDS CAUSED BY RHEUMATIC DISEASE. IT WAS ALSO REPORTED THAT THE BARREL END OF THE SIZER WAS USED, AND THE REPLICA END WAS NOT. THE VALVE ANNULUS WAS NOT FELT TO BE BETWEEN 2 DIFFERENT SIZES, AND THE BODY SURFACE AREA (BSA) CHART WAS NOT USED. PLEDGETS WERE USED AND THE VALVE WAS RESIZED AFTER PLEDGET PLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 21918442 ↗