Kangaroo 714100Recalls & reported problems
Cardinal Health, Inc. · Skin Level Balloon Gastrostomy Kit · Class 2 · Implant
All models of Kangaroo (145)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521010628), received between Apr 1, 2022 and Jan 9, 2024 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Unintended Deflation” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Unintended Deflation5
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 9, 2024Unintended Deflation; Unintended Deflation
CUSTOMER REPORTS: THE DEVICE HAD TO BE REPLACED DUE TO A BALLOON LEAK (POSSIBLY RUPTURE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18480244 ↗MalfunctionJun 23, 2023Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT THE DEVICE HAD TO BE REPLACED DUE TO A BALLOON LEAK (POSSIBLY RUPTURE). NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17191869 ↗MalfunctionApr 7, 2023Material Rupture; Material Rupture
THE CUSTOMER REPORTED THAT DUE TO A LEAKING BALLOON (PROBABLY A RUPTURE), THE BALLOON HAD TO BE REPLACED. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS NO PINHOLE NOTICED IN THE BALLOON. PER CUSTOMER, IT WAS FOUND THAT THERE WAS NO PROPER SEALING OF THE PROBE. THEREFORE, THE BALLOON WAS REPLACED. DURING DEVICE REPLACEMENT, THERE WAS NO PART OF THE PROBE (E.G, A PIECE OF BALLOON) COULD REMAIN IN THE PATIENT¿S BODY WAS FOUND. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16704198 ↗MalfunctionJul 19, 2022Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT THE PATIENT NOTICED A BROKEN BALLOON FIVE DAYS AFTER THE INSERTION OF THE PROBE. THE PROBE HAS BEEN REPLACED WITH A NEW ONE. PER ADDITIONAL INFORMATION PROVIDED ON JULY 13, 2022, THE BREAK WAS A CLEAN TEAR, THERE WERE NO FRAGMENTED PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15052475 ↗MalfunctionJul 13, 2022Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT THE PATIENT NOTICED A BROKEN BALLOON FIVE DAYS AFTER THE INSERTION OF THE PROBE. THE PROBE HAS BEEN REPLACED WITH A NEW ONE. PER ADDITIONAL INFORMATION PROVIDED ON JULY 13, 2022, THE BREAK WAS A CLEAN TEAR, THERE WERE NO FRAGMENTED PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15006821 ↗MalfunctionApr 1, 2022Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT THE PROBE HAD A HOLE IN THE BALLOON ON THE FIRST DAY OF USE. PER ADDITIONAL INFORMATION RECEIVED ON 11MAR2022, THERE WAS NO MEDICAL INTERVENTION REQUIRED. THEY WERE NOT INFORMED IF THE DEVICE WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13977942 ↗
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- 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
- NutraGlide Nasal Feeding Tube ENFT-06055-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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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