Avalus™ 40029Recalls & reported problems
Medtronic, Inc. · VALVE 40029 AVALUS AOR MMX U30 US · Class 3 · Implant
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169983229), received between Sep 16, 2025 and Sep 16, 2025 — classified as 1 death.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathSep 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT AN UNKNOWN DURATION POST IMPLANT OF THESE AVALUS ULTRA VALVES, THE PATIENT DIED. THE CAUSE OF DEATH WAS NOT RECEIVED. THEREFORE, RELATEDNESS OF THE DEATH TO THE AVALUS ULTRA DEVICES COULD NOT BE EXCLUDED. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.
Patient problems: Insufficient Information
MAUDE report 23062884 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.