Kangaroo 716200Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521011007), received between Aug 1, 2018 and Jun 22, 2023 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Adverse Event Without Identified Device or Use Problem1
- Fluid/Blood Leak1
- Improper or Incorrect Procedure or Method1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Code Available1
- Scar Tissue1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 22, 2023Material Rupture; Material Rupture
CUSTOMER REPORTS: THE TUBE WAS INSERTED ON (B)(6) 2023 AND THE BURST BALLOON WAS FOUND ON (B)(6) 2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17187843 ↗MalfunctionSep 23, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED FLUID IS GUSHING OUT OF THE DEVICE WHEN THE EXTENSION SET IT REMOVED. ADDITIONAL INFORMATION RECEIVED STATED THE VALVE HAS STOPPED WORKING SO WHEN THEY DETACH THE EXTENSION SET, ANYTHING IN THE STOMACH FLOWS OUT. IMMEDIATELY AFTER A FEED THE FORMULA THAT HAS JUST BEEN ADMINISTERED COMES OUT. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12518492 ↗InjuryAug 1, 2018Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THAT THE NUTRIPORT WAS INSERTED ON (B)(6) 2018 AND REMOVED (B)(6) 2018. WHEN THE SECOND DEVICE WAS REMOVED, THE PATIENT DID NOT INFORM HIS PARENTS. THIS CAUSED THE STOMA TO CLOSE UP AS A RESULT OF THE WITHDRAWAL OF THE DEVICE.
Patient problems: No Code Available; Scar Tissue
MAUDE report 7739587 ↗
Other TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices
- Bard® DigniShield® Stool Management System SMS002C. R. Bard, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 deaths525 reports
- 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 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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