Kangaroo 8884773006Recalls & reported problems

Cardinal Health, Inc. · Pump Set,Ice Pouch · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 20
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10884521028388), received between Aug 8, 2017 and Jan 14, 2019 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (17 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/Splash17
Detachment of Device or Device Component3

Patient problems

No Consequences Or Impact To Patient8
No Known Impact Or Consequence To Patient5
No Patient Involvement4
No Information3

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

MalfunctionJan 14, 2019Leak/Splash; Leak/Splash
THE CUSTOMER STATES THAT AFTER USING A FEW MINUTES, THE TUBE STARTED TO LEAK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8244701 ↗
MalfunctionJan 11, 2019Leak/Splash; Leak/Splash
THE CUSTOMER STATES THAT AFTER USING FOR A FEW MINUTES, THE TUBE STARTED TO LEAK.
Patient problems: No Information
MAUDE report 8240236 ↗
MalfunctionJan 10, 2019Leak/Splash; Leak/Splash
THE CUSTOMER STATES THAT AFTER A FEW MINUTES, THE TUBE STARTS TO LEAK.
Patient problems: No Information
MAUDE report 8237651 ↗
MalfunctionJan 10, 2019Leak/Splash; Leak/Splash
THE CUSTOMER STATES THAT AFTER USING A FEW MINUTES, THE TUBE STARTED TO LEAK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8233282 ↗
MalfunctionMay 18, 2018Leak/Splash; Leak/Splash
THE CUSTOMER STATED THAT AFTER USING A FEW MINUTES, THE TUBE STARTED LEAKING AND IT WAS NOTICED WHILE USING ON THE PATIENT. NO PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7527847 ↗
MalfunctionFeb 14, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER STATES THAT WHEN USING FOR A FEW MINUTES, THE DROPPER IS SEPARATED FROM THE FEEDING TUBE. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7270723 ↗
MalfunctionDec 7, 2017Leak/Splash; Leak/Splash
THE CUSTOMER STATES THAT AFTER USING FOR A FEW MINUTES, THE TUBE STARTED TO LEAK.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7096302 ↗
MalfunctionDec 6, 2017Leak/Splash; Leak/Splash
THE CUSTOMER STATES THAT AFTER USING FOR A FEW MINUTES, THE TUBE STARTED TO LEAK. NO PATIENT HARM WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7087397 ↗
MalfunctionDec 5, 2017Leak/Splash; Leak/Splash
THE CUSTOMER STATES THAT AFTER A FEW MINUTES OF USE, THE TUBE STARTED TO LEAK.
Patient problems: No Information
MAUDE report 7084372 ↗
MalfunctionDec 5, 2017Leak/Splash; Leak/Splash
THE CUSTOMER STATES THAT AFTER USING THE FEEDING SET FOR A FEW MINUTES, THE TUBE STARTED TO LEAK. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7082522 ↗
MalfunctionDec 4, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER STATES THAT THE DROPPER IS SEPARATED FROM THE FEEDING TUBE. NO KNOWN PATIENT INJURY WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7080968 ↗
MalfunctionDec 4, 2017Leak/Splash; Leak/Splash
THE CUSTOMER STATES THAT AFTER USING A FEW MINUTES, THE ENTERAL FEEDING SET TUBE STARTED TO LEAK.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7080641 ↗
MalfunctionDec 4, 2017Leak/Splash; Leak/Splash
THE CUSTOMER STATES THAT AFTER USING A FEW MINUTES, THE TUBE STARTED TO LEAK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7079913 ↗
MalfunctionOct 10, 2017Leak/Splash; Leak/Splash
THE CUSTOMER STATES THAT DURING THE PROCEDURE, THERE ENTERAL FEEDING PUMP SET WAS LEAKING AT THE BOTTOM PRIOR TO PRIMING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 6935293 ↗
MalfunctionSep 27, 2017Leak/Splash; Leak/Splash
ACCORDING TO THE REPORTER, THE PUMP SET WAS LEAKING FROM THE BOTTOM OF THE BAG.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6898997 ↗
MalfunctionSep 27, 2017Leak/Splash; Leak/Splash
THE CUSTOMER REPORTED THAT THE PUMP SET BAG WAS LEAKING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6898741 ↗
MalfunctionSep 27, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PRIOR TO PRIMING, THE DROPPER SEPARATED FROM THE FEEDING TUBE.
Patient problems: No Patient Involvement
MAUDE report 6897677 ↗
MalfunctionSep 26, 2017Leak/Splash; Leak/Splash
ACCORDING TO THE REPORTER, ON (B)(6) 2017, THE ENTERAL PUMP SET LEAK SET PRIOR TO PRIMING.
Patient problems: No Patient Involvement
MAUDE report 6895008 ↗
MalfunctionSep 26, 2017Leak/Splash; Leak/Splash
ACCORDING TO THE REPORTER, THE DEVICE HAD A LEAKAGE WHILE USING ON PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6894534 ↗
MalfunctionAug 8, 2017Leak/Splash; Leak/Splash
THE CUSTOMER REPORTS THAT WHEN FILLING THE BAG WITH THE FEED PRIOR TO USE, A LEAK WAS DETECTED.
Patient problems: No Patient Involvement
MAUDE report 6773309 ↗

Device details

UDI-DI	`10884521028388`
Brand	Kangaroo
Model	8884773006
Company	Cardinal Health, Inc.
Product code	KNT · TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Dec 31, 2025

Device type (GMDN): Enteral feeding noninvasive-component set

A collection of devices such as tubing, connectors, chambers, clamps, and bags/bottles intended to be used to create the noninvasive (i.e., fully external) portion of an enteral feeding device assembly; it is not intended for intravenous (IV) administration. This is a single-use device.

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All TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices →

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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