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Kangaroo 8884720189Recalls & reported problems

Cardinal Health, Inc. · Gastrostomy Feeding Tube with Y-Ports,20 mL · Class 2 · Implant

Adverse event reports
5
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521007284), received between Aug 5, 2022 and Oct 17, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Rupture3
  • Break1
  • Deflation Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions5

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 17, 2022Material Rupture; Material Rupture

    THE CUSTOMER REPORTED THAT THE CUFF BURST. THE PROCEDURE WAS PERFORMED BY A DOCTOR.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15616047 ↗
  • MalfunctionOct 17, 2022Material Rupture; Material Rupture

    THE CUSTOMER REPORTED THAT THE CUFF BURST.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15616019 ↗
  • MalfunctionOct 5, 2022Break; Break

    THE CUSTOMER STATED THE BALLOON WAS BROKEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15543047 ↗
  • MalfunctionAug 25, 2022Deflation Problem; Deflation Problem

    THE CUSTOMER REPORTED THERE WAS A HOLE IN THE BALLOON. DURING USE THEY REALIZED THE BALLOON WAS EMPTYING. THE FEEDING TUBE WAS REPLACED AND THE SECOND FEEDING TUBE ALSO HAD A HOLE IN THE BALLOON AND WAS REPLACED. THERE WAS NO INJURY TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15293183 ↗
  • MalfunctionAug 5, 2022Material Rupture; Material Rupture

    THE CUSTOMER REPORTED THAT THE PROBE BALLOON BREAKS AND MUST BE CHANGED BY THREE DIFFERENT OCCASIONS FOR THE SAME REASON. THEY APPARENTLY HAVE A DEFECT IN THE BATCH USED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15178249 ↗

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.