NA APU540Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20763000122236), received between Sep 29, 2023 and Sep 16, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THESE TWO 4MM AORTIC PUNCHES, IT WAS REPORTED THAT THE PUNCHES DID NOT PUNCH ALL THE WAY THROUGH THE AORTIC TISSUE. AORTIC TISSUE WAS ALSO STUCK IN THE PUNCHES. THE PHYSICIAN USED A BLADE TO CUT THE HOLE INSTEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23066360 ↗
• MalfunctionApr 30, 2025Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO USE OF THIS APU540 AORTIC PUNCH 4 .0MM, THE PACKAGING WAS DAMAGED AND THE PRODUCT WAS REPLACED. IT WAS ALSO REPORTED THAT THE AORTIC PUNCH WAS STORED IN CONVENTIONAL STORAGE AND NO OTHER PRODUCTS STORED IN THIS AREA HAD PACKAGING ISSUES. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934636 ↗
• MalfunctionNov 21, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE USE OF THIS AORTIC PUNCH, IT DID NOT PUNCH AND WAS REPLACED WITH ANOTHER PUNCH OF THE SAME MODEL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20754154 ↗
• MalfunctionJul 4, 2024Packaging Problem; Packaging Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE 6 AORTIC PUNCHES, IT WAS REPORTED THAT THE PACKAGING OF THE AORTIC PUNCHES HAD DEBONDED FROM THE PLASTIC PACKAGING, MAKING THE DEVICES NOT STERILE AS THEY WERE OPEN AND NO LONGER SEALED. IT WAS STATED THAT THE AORTIC PUNCHES WERE AT THE FACILITY FOR ABOUT 20 DAYS AND ONLY THE OUTER BOX PACKAGING WAS CHECKED UPON ARRIVAL AT THE FACILITY. IT WAS REPORTED THAT THE AORTIC PUNCHES WERE STORED AT ROOM TEMPERATURE WITH GOOD VENTILATION AND ALL 6 AORTIC PUNCHES IN THE BOX EXPERIENCED THE SAME DE-BONDING ISSUE. THE DEVICES WERE NOT USED. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19674161 ↗
• InjurySep 29, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE USE OF THIS 4.0MM ACCESSORY DEVICE, IT WAS REPORTED THAT TEARING OF THE PATIENTS AXILLARY ARTERY OCCURRED. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 17847905 ↗