Avalus Ultra™ 400U23Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00763000647049), received between Mar 20, 2025 and Jun 3, 2026 — classified as 2 deaths, 12 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 23MM BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC DEVICE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS PATIENT ANATOMY. IT WAS REPORTED THAT THE SURGEON OVERSIZED THE VALVE AND THE PRODUCT DID NOT MALFUNCTION. IT WAS STATED THAT BOTH THE BARREL END AND REPLICA END OF THE AVALUS SIZERS AND A BODY SURFACE AREA (BSA) CHART WERE USED FOR VALVE SIZING. THE BSA CHART DID NOT INDICATE A LARGER VALVE WAS NEEDED THAN WHAT WAS SIZED FOR THIS PATIENT AND THE ANNULUS WAS NOT FELT TO BE BETWEEN TWO DIFFERENT VALVE SIZES. IT WAS REPORTED THAT PLEDGETS WERE USED AND THE VALVE WAS RE-SIZED FOLLOWING THE PLEDGET PLACEMENT. IT WAS STATED THAT THE SURGEON WAS NEW WITH THE AVALUS VALVE AND SIZERS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25375984 ↗
• InjuryMar 6, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT AN UNKNOWN DURATION POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED V ALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24529885 ↗
• InjuryMar 4, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 21MM AORTIC BI OPROSTHETIC VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS THE 23MM AORTIC BIOPROSTHETIC VALVE WAS TOO BIG AND A 21MM AORTIC BIOPROSTHETIC VALVE WAS SELECTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24504944 ↗
• DeathFeb 19, 2026Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT REPORTED THE PATIENT PRESENTED TO THE FACILITY IN SALVAGE CRITICAL CONDITION, AS THEY HAD SEVERE AORTIC VALVE ENDOCARDITIS. A POSITIVE BLOOD CULTURE WAS CONFIRMED FOR THE SAME ORGANISM FOUND IN A URINE CULTURE WEEKS PRIOR. IT WAS ALSO REPORTED THAT A VEGETATION COULD BE SEEN ON THE PATIENTS NATIVE RIGHT AND NON-CORONARY CUSP. THE PATIENT ALSO HAD SYMPTOMS OF SHORTNESS OF BREATH. RE-INSPECTION OF THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) REVEALED ADDITIONAL ABSCESS AND TISSUE DESTRUCTION, REQUIRING FURTHER DEBRIDEMENT AND PATCH RECONSTRUCTION. THE 23MM AORTIC BIOPROSTHETIC VALVE WAS IMPLANTED AFTER DEBRIDEMENT WAS COMPLETED. IT WAS FURTHER NOTED THAT SUBSEQUENTLY, 1 DAY LATER, THE PATIENT DIED. THE CAUSE OF DEATH WAS NOT RECEIVED. THEREFORE, RELATEDNESS OF THE DEATH TO THE VALVE COULD NOT BE EXCLUDED. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 24394442 ↗
• DeathJan 28, 2026Insufficient Device Problem Information; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE CAUSE OF DEATH AS UNKNOWN. IT WAS FURTHER NOTED THAT THE PATIENT DEATH WAS DETERMINED AS NOT RELATED TO THE DEVICE, BUT WAS RELATED TO THE IMPLANT PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Hypoxia; Insufficient Information

  MAUDE report 24197969 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE 23MM AORTIC BIOPROSTHETIC VALVE WAS EXPLANTED AND REPLACED WITH A 23MM VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. IT WAS FURTHER REPORTED THAT THE PATIENT HAD SEVERE AORTIC VALVE ENDOCARDITIS, AS THEY HAD A POSITIVE BLOOD CULTURE FOR THE SAME ORGANISM FOUND IN A URINE CULTURE WEEKS PRIOR. IT WAS ALSO REPORTED THAT A VEGETATION COULD BE SEEN ON THE PATIENTS NATIVE RIGHT AND NON-CORONARY CUSP. THE PATIENT ALSO HAD SYMPTOMS OF SHORTNESS OF BREATH. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23973109 ↗
• InjuryNov 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 1 MONTH POST IMPLANT OF THIS AVALUS ULTRA BIOPROSTHESIS 23MM VALVE, THE PATIENT REPORTED REDNESS AND INTERMITTENT PAIN AT THE STERNAL INCISION SITE AND WAS FOUND TO HAVE STERNAL WOUND DEHISCENCE. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR STERNAL WOUND MONITORING, AND ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED TO PREVENT PERMANENT INJURY OR IMPAIRMENT. IT WAS FURTHER NOTED THAT 3 STERNAL WASHOUTS WERE PERFORMED, ALONG WITH THE PLACEMENT OF JACKSON-PRATT (JP) DRAINS. IT WAS REPORTED THAT THE STERNAL WOUND GREW PROTEUS AND ANTIBIOTICS WERE GIVEN. IT WAS STATED THAT THE PATIENT HAD MULTIPLE DRAINS. IT WAS REPORTED THAT THE EVENT WAS POSSIBLY RELATED TO THE INDEX PROCEDURE AND NOT THE DEVICE. ON (B)(6) 2025, THE PATIENT WAS REPORTED TO BE HEMODYNAMICALLY STABLE AND WAS DISCHARGED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pain; Unspecified Infection; Wound Dehiscence

  MAUDE report 23523173 ↗
• InjurySep 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE GI BLEEDING WAS ANTICOAGULANT MEDICATION. IT WAS REPORTED THAT THE EVENT WAS NOT RELATED TO THE VALVE AND PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23034112 ↗
• InjuryJul 28, 2025Intravalvular regurgitation; Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED REPORTED THE REASON FOR INTERVENTION AS MILD AORTIC INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22639447 ↗
• InjuryJun 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 21MM VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22366185 ↗
• InjuryJun 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT POST IMPLANT OF THIS 23MM AVALUS VALVE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THIS LED TO A SERIOUS DETERIORATION IN HEALTH AND PROLONGED HOSPITALIZATION. IT WAS STATED THAT ON (B)(6) 2025, THE EVENT RESOLVED AND THE PATIENT RECOVERED. IT WAS REPORTED THAT THE PHYSICIAN DOES NOT BELIEVE THE HEART VALVE CAUSED OR CONTRIBUTED TO THE EVENT. NO ADDITIONAL ADVERSE EVENTS WERE REPORTED.

  Patient problems: Pneumothorax

  MAUDE report 22211479 ↗
• InjuryApr 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE OF THE SAME SIZE AND MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21915190 ↗
• InjuryApr 22, 2025Perivalvular Leak; Perivalvular Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 23MM VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS MODERATE PARAVALVULAR LEAK (PVL) BY THE NON-CORONARY. IT WAS REPORTED THAT THE AVALUS ULTRA SIZER WAS USED FOR VALVE SIZING, BOTH BARREL AND REPLICA END OF THE SIZER WERE USED AND THE REPLICA END OF THE SIZER WAS USED TO SELECT THE SIZE OF THE IMPLANTED VALVE. A BODY SURFACE AREA (BSA) CHART WAS USED FOR VALVE SIZING; THE ANNULUS WAS NOT FELT TO BE BETWEEN TWO DIFFERENT VALVE SIZES AND PLEDGETS WERE USED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 21882638 ↗
• InjuryMar 20, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT POST IMPLANT OF THIS 23MM AVALUS AORTIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 29MM AVALUS AORTIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21651221 ↗