NA APU444Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20763000122144), received between Mar 19, 2025 and Aug 31, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Insufficient Device Problem Information

  Additional information received reported that the device was used during a coronary bypass procedure. No additional adverse patient effects were reported.

  Patient problems: Insufficient Information

  MAUDE report 50523470 ↗
• MalfunctionMay 18, 2026Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USING THIS 4.4MM APU444 AORTIC PUNCH, IT WAS REPORTED THAT THE SURGEON STATED "THE PUNCH WAS CHANGED WITHOUT PHYSICIAN'S KNOWLEDGE OR CONSENT, THE PUNCH IS "ALMOST DANGEROUS", IT IS BLUNT, ROUGH GOING IN, TEAR THE AORTA, TOO SHORT, AND LIKELY TO CAUSE MICRO-DISSECTIONS. NOT A SUITABLE PRODUCT.". NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25200892 ↗
• MalfunctionMar 19, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TRAY CARDIOVASCULAR PACK PUT TOGETHER BY THE FACILITY, CONTAINING THIS 4.4MM AORTIC PUNCH ACCESSORY DEVICE, IT WAS OBSERVED ON PRODUCT PACKAGING THAT THE DEVICE HAD AN EXPIRATION DATE OF JANUARY 2025. THE CUSTOM TRAY WAS LABELED WITH AN EXPIRATION DATE OF MAY 2025 ALONG WITH OTHER SIMILAR AORTIC PUNCH ACCESSORY DEVICES. IT WAS STATED THAT TWO DEVICES OF THIS LOT WITH AN EXPIRATION DATE OF MAY 2025 ARE STILL IN STOCK. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21642364 ↗