Avalus Ultra™ 400U19Recalls & reported problems
Medtronic, Inc. · AVALUSTM ULTRA 400U19 19MM VALVE SIZE · Class 3 · Implant
All models of Avalus Ultra (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000647025), received between Sep 4, 2024 and Jan 29, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Device Markings/Labelling Problem1
- Packaging Problem1
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 29, 2025Unsealed Device Packaging; Packaging Problem; Unsealed Device Packaging; Packaging Problem
ADDITIONAL INFORMATION WAS RECEIVED THAT THE VALVE WAS STORED A REGULAR SECURE VALVE CLOSET AND THE JAR WAS FOUND TO HAVE A LEAK AFTER BEING IN STORAGE FOR A WHILE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21262122 ↗MalfunctionSep 4, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE OF THIS 19MM AORTIC BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE PATIENT STICKER HAD AN INCORRECT MODEL NUMBER. THE PATIENT STICKER WAS MISSING A "U" CHARACTER IN THE MODEL NUMBER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20133115 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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