Kangaroo E5FDRRecalls & reported problems
Cardinal Health 200, LLC · Kangaroo Omni ENtelliSet Thick Formula 500mL · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885380177415), received between Oct 9, 2024 and Oct 9, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Air/Gas in Device” (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.
Reports received per month
Most reported problems
Device problems
- Air/Gas in Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 9, 2024Air/Gas in Device; Air/Gas in Device
THE CUSTOMER REPORTED THAT A HEALTH CARE PROFESSIONAL (HCP) AT THE RESOURCE EXCHANGE IN COLORADO SPRINGS, CO WHO SEES PEDIATRIC OUTPATIENTS ON HOME ENTERAL NUTRITION WAS TOLD BY AN UNKNOWN SOURCE TO USE IDDSI LEVEL 1 WITH THE KANGAROO OMNI ENTERAL FEEDING PUMP THICK FORMULA FEEDING SETS SO SHE WAS ADVISING A COUPLE OF FAMILIES TO DILUTE COMMERCIAL BLENDERIZED TUBE FEEDING (BTF) FORMULAS DOWN TO IDDSI 1 WITH WATER AND IN DOING SO, THE FAMILIES EXPERIENCED OMNI PUMP ALARMS. THEY ARE NOT SURE WHAT TYPE OF ALARM, BUT IT WAS REPORTED TO THEM AS EITHER "CLOGGED FEEDING TUBE" OR "AIR BUBBLES¿. THEY ARE NOT SURE WHAT SPECIFIC FORMULA THEY USED OR IF MODULARS WERE USED, OR IF THE FORMULA WAS HOMOGENOUS WITHOUT LUMPS OR CHUNKS BUT WHEN THEY TRIED A LEVEL 2, THE THICK FORMULA FEEDING SETS WORKED FINE AS THE PUMP AND THICK FEEDING SETS WERE DESIGNED TO DO. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED STATING THE KANGAROO OMNI PUMP WITH THICK FORMULA FEEDING SETS HAD TROUBLE WITH IDDSI LEVEL 1 SHOWING THE ALARM ¿PATIENT TUBE BLOCK¿ BUT WHEN THE FORMULA WAS SWITCHED TO A LEVEL 2 IDDSI FORMULA ¿ THE SAME PUMP WORKED FINE. AIR BUBBLES WERE OBSERVED, ESPECIALLY WITH THINNER MIXTUR
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20406579 ↗
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- Kangaroo 383400Cardinal Health, Inc. · Pump, Infusion, Enteral1 death659 reports
- Infinity Enteral Feeding Pump INFKIT2Zevex International, Inc. · Pump, Infusion, Enteral2 deaths407 reports
- Infinity Enteral Feeding Pump INFP01Zevex International, Inc. · Pump, Infusion, Enteral1 death207 reports
- Perfusor® 8713030UB. Braun Medical Inc. · Pump, infusion, enteral2 recalls3 deaths76 reports
- Kangaroo 775659Cardinal Health, Inc. · PUMP, INFUSION, ENTERAL1 death139 reports
- Perfusor® 8713031UB. Braun Medical Inc. · PUMP, INFUSION, ENTERAL1 recall21 deaths87 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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