Kangaroo 716150Recalls & 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 10884521010987), received between Feb 9, 2022 and Jan 13, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Fluid/Blood Leak1
- Material Puncture/Hole1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 13, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
THE CUSTOMER REPORTED THE PROBE WAS BEING USED BY A CHILD WHO DETECTED THE LEAKAGE OF FOOD. ADDITIONAL INFORMATION RECEIVED STATED THE LEAK IS LOCATED IN THE TUBE WHERE IT MEETS THE END THAT STAYS OUTSIDE THE BODY. THERE WAS A SMALL CRACK. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16156912 ↗MalfunctionSep 7, 2022Material Rupture; Material Rupture
THE CUSTOMER REPORTED THAT THE BALLOON RUPTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15373935 ↗MalfunctionFeb 9, 2022Material Puncture/Hole; Material Puncture/Hole
THE CUSTOMER REPORTED THAT THE BALLOON DID NOT INFLATE. NO INJURIES OCCURRED. PER ADDITIONAL INFORMATION PROVIDED ON 08-FEB-2022, THE ISSUE OCCURRED DURING PATIENT USE. THERE WERE HOLES/CRACKS OBSERVED IN THE BALLOON. THE PROBLEM WAS RESOLVED BY REMOVING AND REPLACING THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13502029 ↗
Other TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices
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- Bard Tri-Funnel Replacement Gastrostomy Tube 000720Bard Access Systems, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 death170 reports
- 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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