Avalus™ 40023Recalls & reported problems

Summary

The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 00643169983199), received between May 10, 2018 and Aug 4, 2026 — classified as 7 deaths, 60 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (35 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 83 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2026Insufficient Device Problem Information; Patient Device Interaction Problem

  Medtronic received information that 1 year and 11 months post implant of this 23mm Avalus bioprosthetic valve, it was explanted and replaced with a 23mm Avalus Ultra heart valve. The reason for the replacement was not reported. No additional adverse patient effects were reported.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 50135288 ↗
• InjuryJun 16, 2026Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 10 MONTHS POST IMPLANT OF THIS 23MM AVALUS AORTIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME (SSS). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 25515790 ↗
• InjuryJun 15, 2026Patient Device Interaction Problem; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 5 MONTHS POST IMPLANT OF THIS 23MM AVALUS AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS HEART FAILURE/HEMODYNAMIC INSTABILITY. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Heart Failure/Congestive Heart Failure

  MAUDE report 25500503 ↗
• InjuryJun 2, 2026Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 10 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 25MM AORTIC BIOPROSTHETIC VALVE OF A DIFFERENT MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25358800 ↗
• InjuryMar 4, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT 7 YEARS AND 7 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS SEVERE AORTIC CENTRAL REGURGITATION. SUBSEQUENTLY IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT SUCCESSFULLY HAD A 26MM AORTIC TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24512801 ↗
• InjuryJan 19, 2026Calcified; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE PATIENT ALSO HAD A 34MM MITRAL ANNULOPLASTY BAND. THE REASON FOR AORTIC VALVE REPLACEMENT WAS REPORTED AS CALCIFICATION, MILD AORTIC INSUFFICIENCY AND SEVERE AORTIC STENOSIS DUE TO AORTIC VALVE ENDOCARDITIS INFECTION. THE PATIENT HAD BEEN PREVIOUSLY HOSPITALIZED ONE MONTH PRIOR, AS THEY ALSO HAD AN ACTIVE ENDOCARDITIS INFECTION OF THEIR MITRAL VALVE. THE PATIENT HAD BEEN TAKING ANTIBIOTIC MEDICATION FOR THE INFECTIVE ENDOCARDITIS. IT WAS FURTHER NOTED THAT THE PATIENT WAS THEN ADMITTED TO THE EMERGENCY DEPARTMENT (ED) DUE TO SWELLING IN BOTH OF THEIR LEGS UP TO THEIR WAIST, AND EXACERBATION OF THEIR EXISTING CONGESTIVE HEART FAILURE (CHF). A TRANSTHORACIC ECHOCARDIOGRAM (TTE) DISCOVERED AN EJECTION FRACTION OF 25%, AND A POSITRON EMISSION TOMOGRAPHY¿COMPUTED TOMOGRAPHY (PET-CT) ALSO DISCOVERED AORTIC VALVE ENDOCARDITIS. A CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE AND MITRAL VALVE REPAIR WITH CHORDAL RECONSTRUCTION DUE TO MILD MITRAL REGURGITATION IN THE SETTING OF INFECTIVE ENDOCARDITIS WAS ALSO PERFORMED CONCOMITANTLY DURING THIS AORTIC VALVE REPLACEMENT. VEGETATION WAS PRESENT ON THE MITRAL VALVE. THE MITRAL ANNULOPLASTY B

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Calcium Deposits/Calcification; Endocarditis; Heart Failure/Congestive Heart Failure; Insufficient Information; Swelling/ Edema

  MAUDE report 24108895 ↗
• InjuryJan 12, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 1 MONTH POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, A DEFIBRILLATOR WAS IMPLANTED.  THE REASON FOR THE DEFIBRILLATOR WAS REPORTED AS SECONDARY PREVENTION (PATIENT SHOCKED PREVIOUSLY). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24035475 ↗
• InjuryOct 22, 2025Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS NOT REPORTED. IT WAS REPORTED THAT ON EVALUATION, CALCIFICATION WAS SEEN IN THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) AND UNDER THE RIGHT CORONARY CUSP (RCC), LEFT CORONARY CUSP (LCC) AND NON-CORONARY CUSP (NCC). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 1 DAY LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification; Insufficient Information

  MAUDE report 23359417 ↗
• InjuryJul 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AN OLD AORTIC TISSUE VALVE WAS EXPLANTED AND REPLACED WITH A NEW AORTIC TISSUE VALVE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22468168 ↗
• InjuryMay 1, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 9 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS SEVERE AORTIC REGURGITATION. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 21942404 ↗
• DeathMar 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT HAD A TISSUE VALVE IMPLANTED IN THE AORTIC POSITION ON (B)(6) 2024. THE PATIENT WAS DECEASED ON (B)(6) 2024. THE CAUSE OF DEATH WAS NOT RECEIVED. THEREFORE, RELATEDNESS OF THE DEATH TO THE PRODUCT COULD NOT BE EXCLUDED. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 21559848 ↗
• InjuryMar 3, 2025Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  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 NOT REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21502316 ↗
• InjuryJan 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED. THE REASON FOR THE EXPLANT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21123973 ↗
• InjuryJan 2, 2025Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  IT WAS REPORTED THAT A AVALUS AORTIC VALVE WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 21056117 ↗
• MalfunctionDec 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WAS BEING EVALUATED FOR A TRANSCATHETER AORTIC VALVE REPLACEMENT INVOLVING A AVALUS AORTIC VALVE. THE REASON FOR EVALUATION IS UNKNOWN. THE DEVICE WAS NOTED TO BE IMPLANTED AND REMAINS IN SERVICE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20877568 ↗
• InjuryNov 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 MONTHS POST 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 20585572 ↗
• InjuryOct 17, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 23MM BIOPROSTHETIC VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS SIGNIFICANT OR SEVERE AORTIC REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 20471322 ↗
• MalfunctionOct 1, 2024Calcified; Calcified

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 2 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT OR A REDO SURGICAL AORTIC VALVE REPLACEMENT. THE REASON FOR EVALUATION WASNOT REPORTED. IT WAS STATED THAT THE PATIENT APPEARS TO HAVE A RADIOPAQUE SUTURE DEVICE NEAR THE SURGICAL AORTIC VALVE, CALCIUM SEEN UNDER THE LEFT CORONARY CUSP (LCC) IN THE THE LEFT VENTRICULAR OUTFLOW TRACT, BEND SEEN IN THE ASCENDING AORTA AND THE DESCENDING THORACIC AORTA APPEARS TORTUOUS. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 20341967 ↗
• InjuryOct 1, 2024Insufficient 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 AORTIC BIOPROSTHETIC 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 20341721 ↗
• InjuryJun 28, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 25MM VALVE OF A DIFFERENT MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS THE VALVE WAS INFECTED WITH BACTERIA. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Abscess; Dyspnea; Endocarditis; Fever; Hypoxia; Low Blood Pressure/ Hypotension; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 19631391 ↗
• InjuryJun 20, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 8 DAYS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT COMPLAINING OF IRREGULAR HEARTBEAT. IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED A NEW ONSET OF ATRIAL FIBRILLATION (AFIB) WITH RIGHT VENTRICULAR RESPONSE (RVR). AN ELECTROCARDIOGRAM (ECG) ALSO SHOWED A HEART RATE OF 124 WITH NONSPECIFIC ST AND T-WAVES. IT WAS ALSO NOTED THAT THE PATIENT WAS MILDLY HYPOTENSIVE. THE PATIENT WAS ADMINISTERED A CALCIUM CHANNEL BLOCKER MEDICATION AND SALINE AND WAS SUBSEQUENTLY STARTED ON A ANTIARRHYTHMIC INFUSION AND WAS ADMINISTERED ANTICOAGULATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes

  MAUDE report 19574303 ↗
• InjuryJun 18, 2024Perivalvular Leak; Patient Device Interaction Problem; Perivalvular Leak; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 4 MONTHS POST 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 ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED WHICH STATED THAT THE REASON FOR THE REPLACEMENT WAS SEPSIS WITH SEPTIC SHOCK, ENDOCARDITIS, AORTIC INSUFFICIENCY (AI), AND ANNULAR DEHISCENCE WITH A PEAK GRADIENT OF 29MMHG. IT WAS STATED THAT THE ORGANISM CULTURED WAS STAPHYLOCOCCUS AUREUS BACTEREMIA. IT WAS REPORTED THAT A MOBILE ECHO DENSITY WAS OBSERVED ON THE AORTIC SURFACE OF THE VALVE ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE PRESENCE OF VEGETATION WAS ALSO REPORTED. ANTIBIOTICS WERE ADMINISTERED. IT WAS REPORTED THAT IMMEDIATELY AFTER VALVE REPLACEMENT, THE PATIENT WAS IN A MIXED SHOCK STATE CONCERNING FOR CARDIOGENIC AS WELL AS SEPTIC SHOCK. MEDICATION WAS ADMINISTERED TO TREAT THE HEMODYNAMIC INSTABILITY. THE PATIENT WAS ADMINISTERED PRESSOR MEDICATIONS AND WAS ON MECHANICAL VENTILATION SUPPORT POST VALVE REPLACEMENT PROCEDURE. IT WAS ALSO STATED THAT A TRIVIAL PARAVALVULAR LEAK WAS NOTED ON TRANSESOPH

  Patient problems: Cardiogenic Shock; Pleural Effusion; Septic Shock; Valvular Insufficiency/ Regurgitation

  MAUDE report 19558046 ↗
• DeathJun 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION FROM A PATIENT REPRESENTATIVE THAT 6 DAYS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT DIED. THE CAUSE OF DEATH WAS RECEIVED AS COMPLICATIONS OF KIDNEY AND LIVER FAILURE POST SURGERY. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Liver Failure; Renal Impairment

  MAUDE report 19448618 ↗
• InjuryMay 15, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE REASONS FOR THE PERMANENT PACEMAKER WERE ALSO RIGHT BUNDLE BRANCH BLOCK (RBBB), SINUS BRADYCARDIA AND INTERMITTENT COMPLETE HEART BLOCK (CHB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia; Heart Block; Non specific EKG/ECG Changes

  MAUDE report 19321318 ↗
• InjuryMay 8, 2024Gradient Increase; Insufficient Device Problem Information; Patient Device Interaction Problem; Intravalvular regurgitation; Gradient Increase; Insufficient Device Problem Information; Patient Device Interaction Problem; Intravalvular regurgitation

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION WHICH STATED THAT THE REASON FOR THE REPLACEMENT WAS SEPSIS WITH SEPTIC SHOCK, ENDOCARDITIS, AORTIC INSUFFICIENCY (AI), AND ANNULAR DEHISCENCE WITH A PEAK GRADIENT OF 29MMHG. IT WAS STATED THAT THE ORGANISM CULTURED WAS STAPHYLOCOCCUS AUREUS BACTEREMIA. IT WAS REPORTED THAT A MOBILE ECHO DENSITY WAS OBSERVED ON THE AORTIC SURFACE OF THE VALVE ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE PRESENCE OF VEGETATION WAS ALSO REPORTED. ANTIBIOTICS WERE ADMINISTERED. IT WAS REPORTED THAT IMMEDIATELY AFTER VALVE REPLACEMENT, THE PATIENT WAS IN A MIXED SHOCK STATE CONCERNING FOR CARDIOGENIC AS WELL AS SEPTIC SHOCK. MEDICATION WAS ADMINISTERED TO TREAT THE HEMODYNAMIC INSTABILITY. THE PATIENT WAS ADMINISTERED PRESSOR MEDICATIONS AND WAS ON MECHANICAL VENTILATION SUPPORT POST VALVE REPLACEMENT PROCEDURE. IT WAS ALSO STATED THAT A TRIVIAL PARAVALVULAR LEAK WAS NOTED ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) POST PROCEDURE. IT WAS FURTHER NOTED THAT A SMALL LEFT PLEURAL EFFUSION HAD ALSO BEEN OBSERVED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Endocarditis; Insufficient Information; Sepsis; Septic Shock

  MAUDE report 19268571 ↗