NA APU440Recalls & reported problems
Medtronic, Inc. · AORTIC PUNCH SH 440 SUA · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20763000122137), received between Sep 2, 2025 and Sep 2, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Dull, Blunt” (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
- Dull, Blunt1
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.
MalfunctionSep 2, 2025Dull, Blunt; Dull, Blunt
MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS 4.0MM AORTIC PUNCH IN A SINGLE VESSEL CORONARY ARTERY BYPASS PROCEDURE, IT WAS REPORTED THAT WHEN MAKING THE SECOND CUT, THE AORTIC PUNCH WAS DAMAGING THE TISSUE AND NOT CUTTING IT. A NEW AORTIC PUNCH WAS USED INSTEAD. NO INTERVENTION TO REPAIR TISSUE OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 22946332 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.