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Kangaroo 724350Recalls & reported problems

Cardinal Health, Inc. · Skin Level Balloon Gastrostomy Kit · Class 2 · Implant

All models of Kangaroo (145)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521011465), received between Feb 10, 2022 and Feb 23, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Material Puncture/Hole1
  • Unintended Deflation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

  • MalfunctionFeb 23, 2022Unintended Deflation; Unintended Deflation

    THE CUSTOMER REPORTED THAT AFTER TWO DAYS OF USING THE PROBE, IT DISLODGED BECAUSE THE BALLOON WAS NOT HOLDING INFLATION. PER ADDITIONAL INFORMATION RECEIVED, THE DOCTOR HAD TO GO TO THE PATIENT'S HOME TO PERFORM THE REPLACEMENT. THE DEVICE WAS REPLACED BY ANOTHER NUTRIPORT TUBE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13585746 ↗
  • MalfunctionFeb 10, 2022Material Puncture/Hole; Material Puncture/Hole

    THE CUSTOMER REPORTED THAT WHEN INTRODUCING THE BUTTON, THE DOCTOR IDENTIFIED THAT THE BALLOON WAS STUCK, AND IT WAS NECESSARY TO CHANGE THE PROBE. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS A HOLE OBSERVED IN THE BALLOON.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13506942 ↗

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Sources and updates

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