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Kangaroo 712120Recalls & reported problems

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

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 10884521010499), received between Jun 25, 2021 and Jul 15, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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

Device problems

  • Fluid/Blood Leak1
  • 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.

  • MalfunctionJul 15, 2022Unintended Deflation; Unintended Deflation

    THE CUSTOMER REPORTED THAT THE GASTROSTOMY FEEDING TUBE WAS REMOVED DUE TO A "HOLE" IN THE BALLOON. A TEST WAS PERFORMED AND THE LEAK WAS IDENTIFIED. THE PROCEDURE WAS PERFORMED ON (B)(6) 2022 AND THE MATERIAL WAS REMOVED ON (B)(6) 2022.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15031909 ↗
  • MalfunctionJun 25, 2021Fluid/Blood Leak; Fluid/Blood Leak

    CUSTOMER REPORTS: DURING TESTING, THE GASTROSTOMY BUTTON, THE BALLOON LEAKED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12067130 ↗

Other TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices

All TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.