Avalus Ultra™ 400U21Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000647032), received between Oct 1, 2024 and Dec 22, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS WHEN LOWERING THE VALVE INTO THE ANNULUS, THE SURGEON NOTICED THE VALVE NOT SLIDING WELL INTO THE ANNULUS AND NOTICED THE SUTURES HAD BEEN TWISTED WHEN PLACED IN THE SEWING CUFF. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23865640 ↗
• MalfunctionAug 13, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE JAR APPEARED TO BE DAMAGED AND A FLUID LEAK WAS APPARENT ON THE EXTERIOR BOX OF AN AVALUS DEVICE. THE DEVICE WAS INSPECTED BEFORE USE AND WAS NEVER IMPLANTED. ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE, AND THERE WAS NO DELAY IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22791916 ↗
• InjuryJun 23, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT POST IMPLANT OF THIS AVALUS VALVE, THE PATIENT SUFFERED FROM UNSTABLE HEMODYNAMICS (1000 ML/HR) AND RECEIVED 3 UNITS OF BLOOD. THE PATIENT WAS ADMITTED TO THE OPERATING ROOM FOR RE-EXPLORATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22306127 ↗
• InjuryOct 1, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 11 DAYS POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR IMPLANT WAS REPORTED AS CARDIOMYOPATHY AND NEW YORK HEART ASSOCIATION (NYHA) CLASS IV. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiomyopathy

  MAUDE report 20345684 ↗