NA APU544Recalls & reported problems
Medtronic, Inc. · AORTIC PUNCH LH 544 SUA · Class 1
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20763000122243), received between Jul 29, 2026 and Jul 29, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Packaging Problem” (5 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Packaging Problem5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 29, 2026Packaging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50073683 ↗MalfunctionJul 29, 2026Packaging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50073677 ↗MalfunctionJul 29, 2026Packaging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50073663 ↗MalfunctionJul 29, 2026Packaging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50073661 ↗MalfunctionJul 29, 2026Packaging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50073647 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.