Avalus™ 40027Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00643169983212), received between Apr 23, 2019 and Sep 29, 2026 — classified as 3 deaths, 40 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (20 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 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Patient Device Interaction Problem

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 50929046 ↗
• InjuryJun 2, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 3 YEARS AND 8 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 27MM AORTIC BIOPROSTHETIC VALVE OF A DIFFERENT MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 25358754 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 3 YEARS AND 3 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 27MM AORTIC BIOPROSTHETIC VALVE OF A NEW MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25300459 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 7 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 29MM 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 24857946 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE REASON FOR REPLACEMENT AS INFECTION. THE TYPE OF INFECTION OR ORGANISM CULTURED WAS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 24506288 ↗
• InjuryFeb 16, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT 6 YEARS AND 6 MONTHS POST IMPLANT OF THIS 27MM 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 ON (B)(6) 2026 THE PATIENT SUCCESSFULLY HAD A 29MMM AORTIC TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24344881 ↗
• InjuryJan 26, 2026Calcified; Device Stenosis

  IT WAS REPORTED THAT 3 YEARS AND 5 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS VALVE STENOSIS. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALISED. EVIDENCE OF CALCIFICATION WAS IN THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) UNDER THE LEFT CORONARY CUSP (LCC), RIGHT CORONARY CUSP (RCC), NON CORONARY CUSP (NCC) AND IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). SUBSEQUENTLY ON (B)(6) 2026, THE PATIENT SUCCESSFULLY HAD A 29MM AORTIC TRANSCATHETER VALVE IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Calcium Deposits/Calcification

  MAUDE report 24176319 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 2 YEARS AND 8 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23875600 ↗
• InjuryDec 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 7 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS INCOMPLETE ATRIOVENTRICULAR BLOCK (AVB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 23776440 ↗
• DeathDec 4, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 2 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT DIED. THE CAUSE OF DEATH WAS RECEIVED AS METHICILLIN-RESISTANT STAPHYLOCOCCUS AEREUS (MRSA) BACTEREMIA SEPSIS. IT WAS ALSO NOTED THAT ENDOCARDITIS WAS DISCOVERED AND ACTIVE THE DAY OF IMPLANT. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis

  MAUDE report 23717686 ↗
• InjuryNov 4, 2025Gradient Increase; Device Stenosis; Gradient Increase; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 10 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 NOT REPORTED. IT WAS REPORTED THAT CALCIFICATION COULD BE SEEN IN THE RIGHT INNOMINATE ARTERY (RCIA). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 1 MONTH LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS AORTIC STENOSIS AND A HIGH MEAN GRADIENT OF 115MMHG. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 23466221 ↗
• InjurySep 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 5 MONTHS POST IMPLANT OF THIS AVALUS VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS BRADY/TACHY SYNDROME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia; Tachycardia

  MAUDE report 23010037 ↗
• InjuryJul 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 DAY POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 22462142 ↗
• InjuryJul 3, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 10 MONTHS POST IMPLANT OF THIS 27MM AVALUS VALVE, IT WAS EXPLANTED AND REPLACED WITH A 29MM FREESTYLE VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 22392843 ↗
• InjuryJul 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 11 MONTHS POST IMPLANT OF THIS 27MM AVALUS VALVE, IT WAS EXPLANTED AND REPLACED WITH A 25MM HANCOCK VALVED CONDUIT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22370762 ↗
• InjuryJan 30, 2025Gradient Increase; Patient Device Interaction Problem; Device Stenosis; Gradient Increase; Patient Device Interaction Problem; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD SYMPTOMS OF HEART FAILURE PRIOR TO THE TRANSCATHETER VALVE BEING IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 21274747 ↗
• MalfunctionJan 9, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE JAR IN WHICH AN AVALUS VALVE WAS CONTAINED IN WAS FOUND TO BE LEAKING. THE DEVICE WAS NEVER IMPLANTED. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112727 ↗
• MalfunctionJan 9, 2025Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A AVALUS VALVE HAS A HIGHER THAN EXPECTED GRADIENT AS SEEN ON A FOLLOW-UP TRANSTHORACIC ECHOCARDIOGRAM, WITH THE MEAN GRADIENT IN THE 20'S. IT WAS STATED THAT THE PHYSICIAN SUGGESTED A POSSIBLE SUBVALVULAR IMPACT TO THE GRADIENT DUE TO THE PATIENT'S ANATOMY. IT WAS INDICATED THAT THE AT THE TIME OF VALVE IMPLANT, THE PATIENT HAD A BICUSPID AORTIC VALVE (BAV) AND AN ANEURYSMAL AORTA WHICH REQUIRED A GRAFT TO FIX. IT WAS ALSO NOTED THAT THE PATIENT HAD A THICK HEART AND THE NATIVE BAV WAS MODERATELY STENOSED. THE VALVE REMAINS IMPLANTED WITH THE HIGHER THAN EXPECTED GRADIENT.

  Patient problems: Insufficient Information

  MAUDE report 21109680 ↗
• InjuryDec 12, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 MONTH POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR IMPLANT WAS REPORTED AS CARDIOMYOPATHY. IT WAS REPORTED THAT THE PATIENT WAS CLASSIFIED AS (B)(6) CLASS II. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiomyopathy

  MAUDE report 20914666 ↗
• InjuryNov 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 8 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20586360 ↗
• InjuryOct 11, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURERS VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS AORTIC INSUFFICIENCY (AI). IT WAS STATED THAT A HIGH DEGREE OF CENTRAL JET WAS NOTED AND THE LEAFLETS OF THE VALVE WERE CHECKED BUT THE VALVE APPEARED TO BE IN GOOD SHAPE. IT WAS STATED THAT NO OBVIOUS CAUSE OF THE CENTRAL LEAK COULD BE FOUND. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 20425882 ↗
• InjurySep 19, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 1 MONTH POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A DEVICE OF A DIFFERENT MANUFACTURER. THE REASON FOR THE REPLACEMENT WAS REPORTED AS INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 20255166 ↗
• MalfunctionAug 23, 2024Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A DEVICE OF A DIFFERENT MANUFACTURER. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20046074 ↗
• InjuryApr 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEARS AND 11 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 29MM BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. CONCOMITANTLY THE PATIENT HAD A MITRAL BIOPROSTHETIC VALVE IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19091230 ↗
• InjuryApr 3, 2024Incomplete Coaptation; Intravalvular regurgitation; Incomplete Coaptation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THERE WAS POOR COAPTATION OF THE VALVE LEAFLETS. IT WAS STATED THAT SEVERE AORTIC INSUFFICIENCY (AI) WAS PRESENT FOR ABOUT 5-10 MINUTES POST IMPLANT AFTER HAVING SEATED THE VALVE IN AND THEN CLOSED THE INCISION. IT WAS FURTHER STATED THAT THE PATIENT WAS PUT ON A PUMP AND THE ISSUE RESOLVED INSTANTLY WITH THE LEAFLETS RETURNING BACK TO NORMAL AND NO CENTRAL JET OBSERVED. CENTRAL JET APPEARED THEN RESOLVED ON ITS OWN. IT WAS NOTED THAT THE DEVICE HAD BEEN INSPECTED PRIOR TO USE. IT WAS MENTIONED THAT THE PATIENT WAS DISCHARGED AND IS DOING WELL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 19031926 ↗