NA APU535Recalls & reported problems
Medtronic, Inc. · AORTIC PUNCH LH 535 SUA · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20763000122229), received between Apr 22, 2026 and Aug 3, 2026 — classified as 3 malfunctions.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information3
Patient problems
- Insufficient Information3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 3, 2026Insufficient Device Problem Information
Patient problems: Insufficient Information
MAUDE report 50117230 ↗MalfunctionMay 4, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT DURING USE OF THIS AORTIC PUNCH TO CREATE AN OPENING IN THE PATIENT¿S AORTA, THE PUNCH BECAME JAMMED AND COULD NOT BE USED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 25068813 ↗MalfunctionApr 22, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT DURING USE OF THIS AORTIC PUNCH FOR A PROXIMAL VESSEL ANASTOMOSIS PROCEDURE, THE AORTIC PUNCH WAS JAMMED AND COULD NOT BE USED. THE DEVICE WAS REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 24953727 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.