Kangaroo E10FDRRecalls & reported problems
Cardinal Health 200, LLC · Kangaroo Omni ENtelliSet Thick Formula 1000mL · Class 2
- 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 10885380177392), received between Oct 8, 2024 and May 6, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (3 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.
Reports received per month
Most reported problems
Device problems
- Air/Gas in Device3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2026Air/Gas in Device
THE CUSTOMER REPORTED THE TEAM HAS BEEN REPORTING AN INCREASE IN "CASSETTE SLIPPED" AND "CASSETTE ERROR" ALARMS. STAFF ARE NOTICING INCREASED AIR IN THE LINE, DESCRIBED AS THE FORMULA RUNNING DOWN ONE SIDE OF THE TUBING INSTEAD OF FULLY OCCUPYING THE LINE, WITH THE FORMULA FILING ONLY PART OF THE TUBING RATHER THAT THE ENTIRE LUMEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25093546 ↗MalfunctionJan 24, 2025Air/Gas in Device; Air/Gas in Device
THE CUSTOMER REPORTED THEY NEEDED TO PULL ON THE BAG TO HOLD IT STRAIGHT DURING PRIMING OTHERWISE THERE WAS A GAP OF AIR THAT OCCURS AND DOESN'T READILY MOVE THROUGH THE TUBING. THE BOTTOM WHERE THE TUBING MEETS THE BAG WASN'T TWISTED WHEN SHE CHANGED THE BAG SATURDAY VS THE BAG, SHE HAD USED PRIOR. IT DID TEND TO BUNCH UP A BIT BUT DID NOT CAUSE ANY ALARMS. SHE DIDN'T ATTEMPT TO PUT THE BAG IN A BACKPACK AS THAT SEEMS TO CAUSE THE PUMP TO ALARM. ADDITIONAL INFORMATION RECEIVED STATED THE AIR GAP WAS NOT IN THE BAG. THE FORMULA DID PRIME THROUGH THE TUBE BUT THERE WAS A GAP OF AIR, AND THE FORMULA PRIMED AROUND IT. THE BOTTOM OF THE BAG IS TWISTING AND BUNCHING UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21228829 ↗MalfunctionOct 8, 2024Air/Gas in Device; Air/Gas in Device
THE CUSTOMER REPORTED WHEN USING STANDARD FORMULA IN A THICK FORMULA SET, AIR BUBBLES FREQUENTLY FORM IN THE LINE CREATING POCKETS OF AIR. THE PUMP IS PAUSED AND REPRIMED WHICH EXPELS SOME FORMULA WHEN TRYING TO GET THE BUBBLES OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20400659 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.