Kangaroo 724200Recalls & reported problems
Cardinal Health, Inc. · Skin Level Balloon Gastrostomy Kit · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521011410), received between Jun 29, 2020 and Oct 24, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak2
- Unintended Deflation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 24, 2024Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THE DEVICE WAS PLACED ON JUNE 22, 2023 AND EXTERNALIZATION OCCURRED DUE TO A MICRO-HOLE IN THE CUFF ON JULY 12, 2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20524301 ↗MalfunctionSep 16, 2021Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTS: LEAKS IN THE INNER BALLOON. IT WAS THE FIRST TIME OF USE AND IT DID NOT INTERVENE WITH THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12482118 ↗MalfunctionJun 29, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE PATIENT WAS IN DECUBITUS DORSAL POSITION, INFUSING ARTISANAL DIET AS USUAL AND THE PARENT NOTICED INTENSE LEAKAGE, WHEN HE LOOKED AT THE BALLOON, IT WAS ALREADY SLIGHTLY EXTERNALIZED. THE NURSING TECHNICIAN ON DUTY ALSO SAW IT AND WHEN THEY PICKED UP THE BALLOON, THEY SAW IT WAS LEAKING DUE TO SPONTANEOUS RUPTURE OF THE CUFF. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THAT THE PROBE WAS LOOSE, ALLOWING THE LEAK OF THE DIET THROUGH THE OSTOMY. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10206297 ↗
Other TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices
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- EndoVive Safety PEG Kit M00566470Boston Scientific Corporation · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall1 death111 reports
- Kangaroo 8884711253Cardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)152 reports
- Kangaroo 8884711253ECardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)100 reports
- NutraGlide Nasal Feeding Tube ENFT-05055-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-06090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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