NA APU548Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20763000122250), received between Jun 19, 2024 and Jun 19, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Packaging Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionJun 19, 2024Unsealed Device Packaging; Packaging Problem; Unsealed Device Packaging; Packaging Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THREE ACCESSORY DEVICES, IT WAS REPORTED THAT PACKAGING DEFECTS WERE OBSERVED. IT WAS STATED THAT THE PACKAGE SEALS WERE BROKEN AND WERE OPEN AND IT WAS NOTED THAT IT LOOKED LIKE THE PLASTIC WAS MELTED ON ONE SIDE. THE DEVICES WERE NOT USED. IT WAS ALSO REPORTED THAT THE FACILITY HAD THESE DEVICES IN STORAGE FOR THREE MONTHS PRIOR TO NOTICING THE PACKAGE DEFECT. THE DEVICES WERE STORED IN A BIN ON A SHELF IN A HALLWAY. NO OTHER DEVICES STORED HERE HAD PACKAGING ISSUES. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19570619 ↗
• MalfunctionJun 19, 2024Unsealed Device Packaging; Packaging Problem; Unsealed Device Packaging; Packaging Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THREE ACCESSORY DEVICES, IT WAS REPORTED THAT PACKAGING DEFECTS WERE OBSERVED. IT WAS STATED THAT THE PACKAGE SEALS WERE BROKEN AND WERE OPEN AND IT WAS NOTED THAT IT LOOKED LIKE THE PLASTIC WAS MELTED ON ONE SIDE. THE DEVICES WERE NOT USED. IT WAS ALSO REPORTED THAT THE FACILITY HAD THESE DEVICES IN STORAGE FOR THREE MONTHS PRIOR TO NOTICING THE PACKAGE DEFECT. THE DEVICES WERE STORED IN A BIN ON A SHELF IN A HALLWAY. NO OTHER DEVICES STORED HERE HAD PACKAGING ISSUES. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19570565 ↗
• MalfunctionJun 19, 2024Unsealed Device Packaging; Packaging Problem; Unsealed Device Packaging; Packaging Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THREE ACCESSORY DEVICES, IT WAS REPORTED THAT PACKAGING DEFECTS WERE OBSERVED. IT WAS STATED THAT THE PACKAGE SEALS WERE BROKEN AND WERE OPEN AND IT WAS NOTED THAT IT LOOKED LIKE THE PLASTIC WAS MELTED ON ONE SIDE. THE DEVICES WERE NOT USED. IT WAS ALSO REPORTED THAT THE FACILITY HAD THESE DEVICES IN STORAGE FOR THREE MONTHS PRIOR TO NOTICING THE PACKAGE DEFECT. THE DEVICES WERE STORED IN A BIN ON A SHELF IN A HALLWAY. NO OTHER DEVICES STORED HERE HAD PACKAGING ISSUES. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19570561 ↗