Avalus Ultra™ 400U27Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00763000647063), received between Jan 6, 2025 and Sep 17, 2026 — classified as 17 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (13 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Insufficient Device Problem Information

  Medtronic received information that 1 year 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 50798994 ↗
• InjuryMar 13, 2026Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT AN UNKNOWN DURATION POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE PATIENT HAD ENDOCARDITIS. THE ORGANISM CULTURED WAS ESCHERICHIA COLI (E.COLI). MEDICATION WAS ADMINISTERED. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis

  MAUDE report 24590423 ↗
• InjuryJan 27, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 13 DAYS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS ATRIAL ARRYTHMIAS (ATRIAL TACHYCARDIA (AT), ATRIAL FIBRILLATION (AF), AND ATRIAL FLUTTER (A-FL)). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Atrial Flutter; Bradycardia; Non specific EKG/ECG Changes; Tachycardia

  MAUDE report 24187130 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN MEDTRONIC VALVE PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS DURING IMPLANT, THE VALVE SUTURES LOOKED TO BE MISPLACED, OR POSSIBLY GOING INTO THE LEAFLETS. IT WAS FURTHER NOTED THAT THE VALVE AREA WHERE THE LEAFLETS MEET THE CUFF WAS CRIMPED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24069313 ↗
• InjuryDec 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 5 DAYS 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 (CHB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 23814784 ↗
• InjuryNov 17, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT POST IMPLANT OF THIS 27MM AVALUS ULTRA VALVE, THE PATIENT ENDED UP BECOMING HYPERTENSIVE ONCE SEDATION WAS OFF REQUIRING INTRAVENOUS (IV) MEDICATION. IT WAS REPORTED THAT THE PATIENT REMAINED HEMODYNAMICALLY STABLE AND WAS DISCHARGED HOME ON (B)(6) 2025. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 23577368 ↗
• InjuryOct 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 MONTH POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE PATIENT HAD SYMPTOMS OF DYSPNEA AT REST AND WITH EXERTION. IT WAS FURTHER REPORTED THAT THE PATIENT ALSO HAD LOWER EXTREMITY EDEMA AND ORTHOPNEA. THE PATIENT WAS THEN ADMITTED TO THE EMERGENCY DEPARTMENT, AND A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) OF THE CHEST DISCOVERED MODERATE BILATERAL PLEURAL EFFUSIONS AND MILD PULMONARY EDEMA. INTRAVENOUS (IV) MEDICATION WAS ADMINISTERED. SUBSEQUENTLY, 2 DAYS LATER, REPEATED DIAGNOSTIC TESTED SHOWED SMALL BILATERAL PLEURAL EFFUSIONS WITH MILD BIBASILAR ATELECTASIS AND PULMONARY EDEMA. THE PATIENT WAS THEN DISCHARGED HOME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dyspnea; Pleural Effusion; Pulmonary Edema; Swelling/ Edema

  MAUDE report 23358230 ↗
• InjuryOct 21, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

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

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 23349020 ↗
• MalfunctionOct 15, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 27MM AORTIC AVALUS ULTRA VALVE, IT EXHIBITED POOR COAPTATION OF THE VALVE LEAFLETS. THE DEVICE WAS INSPECTED PRIOR TO USE AND THE PROCEDURE WAS NOT DELAYED. AN ECHOCARDIOGRAM WAS CONDUCTED, WHICH SHOWED FAVORABLE RESULTS, AND THE PATIENT WAS REPORTED TO BE DOING WELL. IT WAS STATED THAT THE SURGEON WAS NOT CONCERNED ABOUT THE VALVE BASED ON THESE FINDINGS. NO TREATMENT OR INTERVENTION HAS BEEN PROVIDED OR PLANNED.

  Patient problems: Insufficient Information

  MAUDE report 23301379 ↗
• InjurySep 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 5 DAYS 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 23049333 ↗
• InjurySep 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS TREATED WITH AN ANTICOAGULANT MEDICATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22938999 ↗
• InjuryAug 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT POST IMPLANT OF THIS 27MM AVALUS VALVE, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION REQUIRING PERICARDIOCENTESIS. THIS RESULTED IN PROLONGED HOSPILIZATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pericardial Effusion

  MAUDE report 22874405 ↗
• InjuryAug 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT POST IMPLANT OF THIS 27MM AVALUS VALVE, THE PATIENT EXPERIENCED ATRIAL FLUTTER THAT REQUIRED INTRAVENOUS ADMINISTRATION OF AMIODARONE AND DIRECT CURRENT CARDIOVERSION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Flutter

  MAUDE report 22873413 ↗
• InjuryAug 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT POST IMPLANT OF THIS 27MM AVALUS VALVE, THE PATIENT EXPERIENCED ACUTE KIDNEY INJURY WHICH PROLONGED HOSPITALIZATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Kidney injury

  MAUDE report 22873120 ↗
• InjuryAug 19, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 2 DAYS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE PATIENT'S HOSPITALIZATION WAS PROLONGED DUE TO CARDIAC TAMPONADE. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND DISCOVERED A NEW LARGE VOLUME HEMOPERICARDIUM. A PERICARDIAL WINDOW WAS PERFORMED AND MEDICATION WAS ADMINISTERED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiac Tamponade

  MAUDE report 22841866 ↗
• InjuryJul 3, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 3 MONTHS POST IMPLANT OF THIS 27MM AVALUS VALVE, IT WAS EXPLANTED AND REPLACED WITH A VALVE OF THE SAME SIZE AND MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 22392832 ↗
• InjuryJun 2, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT POST IMPLANT OF THIS 27MM AVALUS VALVE, IT WAS REPORTED THAT THERE WAS "SOME REGURGITATION". NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22127832 ↗
• InjuryMay 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS AVALUS VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK (CHB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 22112998 ↗
• MalfunctionMar 6, 2025Unsealed Device Packaging; Unsealed Device Packaging

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE VALVE WAS STORED ON THE SHELF STORAGE WITH OTHER VALVES. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21534279 ↗
• MalfunctionJan 9, 2025Incomplete Coaptation; Intravalvular regurgitation; Incomplete Coaptation; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE PATIENT ALSO HAD MILD AORTIC INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 21113705 ↗
• MalfunctionJan 9, 2025Incomplete Coaptation; Intravalvular regurgitation; Incomplete Coaptation; Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT POST IMPLANT THE LEAFLET WAS NOT MOVING AS WELL AS THE OTHER TWO LEAFLETS. IT WAS REPORTED THAT POST IMPLANT NORMAL VALVE GRADIENT WAS NOTED WITH A MEAN GRADIENT OF 7MM HG. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 21112817 ↗
• MalfunctionJan 6, 2025Device Markings/Labelling Problem; Packaging Problem; Device Markings/Labelling Problem; Packaging Problem

  IT WAS REPORTED THAT THE BLUE SERIAL NUMBER WAS DETACHED FROM AN AVALUS VALVE HOLDER AND FLOATING FREELY IN JAR. THE ISSUE WAS RESOLVED BY REMOVING THE TAG FROM THE JAR FOR VERIFICATION. IT WAS STATED THAT THE SERIAL NUMBER ON THE TAG DID NOT MATCH THE SERIAL NUMBER ON STICKERS AND LABEL. THE VALVE WAS IMPLANTED IN THE PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21077687 ↗