Kangaroo 720250Recalls & reported problems
Cardinal Health, Inc. · Skin Level Balloon Gastrostomy Kit · Class 2 · Implant
- 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 10884521011298), received between Feb 8, 2018 and Sep 14, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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.
Most reported problems
Device problems
- Leak/Splash2
- Fluid/Blood Leak1
Patient problems
- No Consequences Or Impact To Patient2
- Discomfort1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2020Fluid/Blood Leak; Fluid/Blood Leak
MalfunctionFeb 8, 2018Leak/Splash; Leak/Splash
THE CUSTOMER REPORTED THE PEG WAS INSERTED ON (B)(6) 2017 AND LASTED 6 WEEKS BEFORE THE PEG VALVE BROKE DOWN AND BEGAN LEAKING. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7251656 ↗MalfunctionFeb 8, 2018Leak/Splash; Leak/Splash
THE CUSTOMER REPORTED THE PEG WAS INSERTED ON (B)(6) 2017 AND FAILED AFTER 5 WEEKS DUE TO THE PEG VALVE BREAKDOWN AND LEAKING. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7251653 ↗
Other TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices
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- CORTRAK* 2 ENTERAL ACCESS SYSTEM 20-0950Avanos Medical, Inc. · Tubes, gastrointestinal (and accessories)1 recall22 deaths134 reports
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.