NA APU448Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20763000122151), received between May 14, 2026 and May 14, 2026 — classified as 2 malfunctions.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USING TWO 4.8MM APU448 AORTIC PUNCH, IT WAS REPORTED THAT THE SURGEON STATED, "THE PUNCHES WERE CHANGED WITHOUT PHYSICIAN'S KNOWLEDGE OR CONSENT, THESE PUNCHES ARE "ALMOST DANGEROUS", THEY ARE 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 25170128 ↗
• MalfunctionMay 14, 2026Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USING TWO 4.8 MM APU448 AORTIC PUNCH, IT WAS REPORTED THAT THE SURGEON STATED, "THE PUNCHES WERE CHANGED WITHOUT PHYSICIAN'S KNOWLEDGE OR CONSENT, THESE PUNCHES ARE "ALMOST DANGEROUS", THEY ARE 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 25169815 ↗