Kangaroo 714150Recalls & 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 10884521010642), received between Feb 3, 2022 and Feb 24, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (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. 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
- Material Rupture2
- Unintended Deflation2
- Leak/Splash1
- Material Puncture/Hole1
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.
MalfunctionFeb 24, 2025Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THE BUTTON LEAKED AFTER JUST 8 DAYS OF USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21445089 ↗MalfunctionJan 22, 2024Leak/Splash; Leak/Splash
THE CUSTOMER REPORTED THAT THE PROBE LEAKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18560201 ↗MalfunctionNov 13, 2023Material Rupture; Material Rupture
CUSTOMER REPORTS: THE BALLOON ON THE SLD BURST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18124864 ↗MalfunctionNov 13, 2023Material Rupture; Material Rupture
CUSTOMER REPORTS: THE BALLOON BURST ON THE SLD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18123801 ↗MalfunctionApr 20, 2023Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT THE DOCTOR INFORMED THAT HE TESTED THE PROBE BEFORE PUTTING IT IN THE PATIENT, CHECKING THE INTEGRITY OF THE MATERIAL, BUT THREE DAYS LATER HE IDENTIFIED A HOLE IN THE BALLOON, MAKING IT IMPOSSIBLE TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16780272 ↗MalfunctionFeb 3, 2022Material Puncture/Hole; Material Puncture/Hole
THE CUSTOMER REPORTED A HOLE IN THE BALLOON. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13446393 ↗
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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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