AvalusRecalls & reported problems across all models

We found 6 models of Avalus by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 288 adverse event reports in the FDA's MAUDE database, received between Mar 15, 2018 and Sep 29, 2026 — classified as 21 deaths, 218 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (115 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Avalus problems

Avalus models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Avalus™ 40025

  heart-valve, non-allograft tissue
  4 deaths89 reports
• Avalus™ 40023

  heart-valve, non-allograft tissue
  7 deaths83 reports
• Avalus™ 40021

  heart-valve, non-allograft tissue
  4 deaths59 reports
• Avalus™ 40027

  heart-valve, non-allograft tissue
  3 deaths48 reports
• Avalus™ 40019

  heart-valve, non-allograft tissue
  2 deaths8 reports
• Avalus™ 40029

  replacement Heart-valve
  1 death1 report

Recent Avalus adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjurySep 15, 2026Insufficient Device Problem Information

  Medtronic received information that 4 years and 8 months post implant of this 21mm aortic bioprosthetic valve, it was explanted and replaced with a new 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 50768051 ↗
• MalfunctionSep 15, 2026Calcified

  It was reported that 7 years and 2 months post implant of this 21mm aortic bioprosthetic valve, the patient is being evaluated for a transcatheter valve-in-valve replacement. The reason for evaluation was not reported. Evidence of calcification was seen in the Left Ventricular Outflow Tract (LVOT) under the right coronary Cusp (RCC), sino-tubular junction (STJ), and anterior calcification in the the right femoral artery (RFA) and left femoral artery (LFA). No intervention or adverse patient effects were reported.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 50767831 ↗
• InjuryAug 8, 2026Device Stenosis

  Medtronic received information that 6 years and 10 months post implant of this 25mm Avalus aortic bioprosthetic valve, the patient is being evaluated for a transcatheter valve-in-valve replacement. The reason for evaluation was reported as aortic stenosis (AS). Intervention is required. No additional adverse patient effects were reported.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 50187218 ↗
• 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 11, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT 2 YEARS AND 11 MONTHS POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS REGURGITATION. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 25468676 ↗
• 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 ↗
• 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 ↗
• MalfunctionMay 13, 2026Device Stenosis

  IT WAS REPORTED THAT 7 YEARS AND 10 MONTHS POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS VALVE STENOSIS. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 25160189 ↗
• InjuryApr 29, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 4 YEARS AND 11 MONTHS POST IMPLANT OF THIS 19MM AORTIC BIOPROSTHETIC VALVE AND 27MM MITRAL BIOPROSTHETIC 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 25026547 ↗
• 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 ↗
• MalfunctionMar 17, 2026Packaging Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, THE VALVE JAR WAS BROKEN UPON OPENING THE PRODUCT PACKAGING. IT WAS FURTHER NOTED THAT THE VALVE WAS NOT USED. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619719 ↗

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