Avalus™ 40019Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169983175), received between Dec 18, 2018 and Apr 29, 2026 — classified as 2 deaths, 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryMar 15, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 6 DAYS POST IMPLANT OF THIS 19MM 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 18912705 ↗
• InjuryFeb 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 1 MONTHS POST IMPLANT OF THIS 19MM 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 18649809 ↗
• DeathNov 30, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE COMPLICATIONS FOLLOWING THE OPEN HEART SURGERY WERE CAUSED BY AN AORTIC DISSECTION. IT WAS ALSO REPORTED THAT THE AORTIC DISSECTION WAS CAUSED BY A DIFFERENT MANUFACTURES WIRE WHILE ATTEMPTING TO CROSS THE NATIVE AORTIC VALVE DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). THE TAVR WAS ULTIMATELY EXPLANTED AND REPLACED WITH THE 19MM AORTIC BIOPROSTHETIC VALVE. IT WAS ALSO REPORTED THAT THE PHYSICIAN BELIEVES THE MEDTRONIC PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT DEATH. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 18237511 ↗
• InjuryNov 10, 2023Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 3 YEARS POST IMPLANT OF THIS 19MM AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS AORTIC STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 18113286 ↗
• MalfunctionAug 6, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  MEDTRONIC RECEIVED INFORMATION THAT THIS 19MM BIOPROSTHETIC AORTIC VALVE WAS IMPLANTED 2 MONTHS AND 4 DAYS BEYOND ITS USE-BY DATE. IT WAS REPORTED THAT THIS PRODUCT WAS THE ONLY ONE OF THIS SIZE AND MODEL THE FACILITY HAD IN INVENTORY. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12288454 ↗
• InjuryAug 28, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 DAYS POST IMPLANT OF THIS BIOPROSTHETIC VALVE, THE PATIENT RECEIVED A PERMANENT PACEMAKER DUE TO ATRIO-VENTRICULAR (AV) BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 8940509 ↗
• DeathDec 18, 2018Inadequacy 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 IMMEDIATELY POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A 19MM VALVE OF THE SAME MODEL FOR UNKNOWN REASONS. ONE DAY POST IMPLANT, THE PATIENT DIED. THE CAUSE OF DEATH WAS NOT RECEIVED. THERE WAS NO EVIDENCE TO SUGGEST THAT THE VALVES OR THEIR FUNCTION CONTRIBUTED TO THE PATIENT¿S DEATH. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Death

  MAUDE report 8174623 ↗