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Kangaroo 718400Recalls & reported problems

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

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521011205), received between May 31, 2022 and May 31, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deflation 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

Device problems

  • Deflation Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 31, 2022Deflation Problem; Deflation Problem

    THE CUSTOMER REPORTED THERE WAS A PINHOLE IN THE BALLOON AND IT DEFLATED. THERE WAS NO MEDICAL INTERVENTION REQUIRED AND NO INJURY TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14546992 ↗

Other TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices

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