Kangaroo 60ENY (UDI 10884521212091)Recalls & reported problems
Cardinal Health, Inc. · Bifurcated Extension Set · Class 2
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 10884521212091), received between Jun 8, 2020 and Jul 14, 2021 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Complete Blockage” (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.
Most reported problems
Device problems
- Complete Blockage5
- Obstruction of Flow1
Patient problems
- No Consequences Or Impact To Patient5
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 14, 2021Obstruction of Flow; Obstruction of Flow
THE CUSTOMER REPORTED THAT THEY ARE HAVING AIRLOCK TROUBLE WITH THESE EXTENSION TUBING SETS. THEY HAVE PULLED THE ENTIRE LOT AND THEY SEEM TO BE FINE NOW. ADDITIONAL INFORMATION PROVIDED STATED THAT THERE WAS EITHER AIR OR A LEAK IN THE TUBING THAT DID NOT ALLOW THE TUBING TO PRIME AND HAVE FEED FLOW CORRECTLY AT A NORMAL RATE. THE TUBING DID NOT LEAK ANY FEED OUT OF IT. THERE WERE NO PATIENT INJURIES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12165696 ↗MalfunctionJun 17, 2020Complete Blockage; Complete Blockage
THE CUSTOMER REPORTED THAT THE NURSE COULD NOT FLUSH FEEDING THROUGH EXTENSION TUBING. THERE WAS NO PATIENT HARM REPORTED. THE EXTENSION TUBING WAS REPLACED. THE NASOGASTRIC (NG) TUBE DID NOT REQUIRE A REPLACEMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10165644 ↗MalfunctionJun 12, 2020Complete Blockage; Complete Blockage
THE CUSTOMER REPORTED THAT THE END USER CAN'T FLUSH OR ADMINISTER ANYTHING THROUGH THE Y CONNECTOR ON THE EXTENSION SET.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10148711 ↗MalfunctionJun 9, 2020Complete Blockage; Complete Blockage
THE CUSTOMER REPORTED THAT WHEN THEY ATTACHED THE SYRINGE TO THE TUBING AND WENT TO FLUSH IT WITH THE MILK THAT IT WOULD NOT FLUSH. THEY HAD TO CHANGE TO ANOTHER TUBING THAT DID WORK. THIS WAS NOT A SITUATION WHERE THE TUBING WAS ALREADY INFUSING. THEY ALSO HAVE FOUND THAT IT DID NOT MATTER WHETHER THEY WERE USING BREASTMILK OR FORMULA, THEY CAN NOT FLUSH ANYTHING THROUGH THE TUBING. THIS IS BEFORE THEY ATTACHED IT TO THE FEEDING TUBING. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10136289 ↗MalfunctionJun 9, 2020Complete Blockage; Complete Blockage
THE CUSTOMER REPORTED THAT THE NURSE STATED THAT THE DEVICE WAS UNABLE TO FLUSH EXPRESSED BREAST MILK THROUGH THE EXTENSION LINE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10132686 ↗MalfunctionJun 8, 2020Complete Blockage; Complete Blockage
THE CUSTOMER REPORTED THAT THE NURSE COULD NOT FLUSH ANYTHING THROUGH THE TUBING. THE PATIENT DID NOT SUFFER ANY INJURY. THE EXTENSION TUBING WAS REPLACED. THE NG TUBE DID NOT NEED REPLACEMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10130899 ↗
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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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