Kangaroo 8884705008E (UDI 30884521657612)Recalls & reported problems
Cardinal Health, Inc. · Y-Site Extension with ENFit Connection, 6" (15.2 cm) · Class 2
All models of Kangaroo (145)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 30884521657612), received between Sep 29, 2020 and Feb 12, 2026 — classified as 1 injury, 6 malfunctions.
The most frequently reported specific device problem is “Break” (4 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.
Reports received per month
Most reported problems
Device problems
- Break4
- Fluid/Blood Leak3
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient2
- Hypoglycemia1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 12, 2026Break
THE CUSTOMER REPORTED FIVE OF THE TEN UNITS WERE USED, AND SEVERAL EITHER LEAKED OR SEPARATED AT THE TOP WHERE THE SYRINGE CONNECTS. LEAKING WAS OCCURRING FROM THE Y-SECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24322163 ↗MalfunctionAug 19, 2025Break; Break
THE CUSTOMER REPORTED THAT ONCE THEY BEGAN TO USE EACH EXTENSION SET, THEY WOULD EXPERIENCE LEAKAGE FROM THE Y-PORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22843792 ↗MalfunctionMar 14, 2025Break; Break
THE CUSTOMER REPORTED THE PORT CONNECTED TO THE KANGAROO FEEDING SETUP BROKE OFF DURING USE. ONCE BROKEN OFF OF EXTENSION, FEEDING WAS NOT ABLE TO BE DELIVERED UNTIL THE Y-CONNECTOR EXTENSION COULD BE REPLACED. THIS ALSO IMPACTED MEDICATION ADMINISTRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21605949 ↗InjuryJun 3, 2024Break; Break
CUSTOMER REPORTS: THE Y-SITE CONNECTOR WITH ENFIT CONNECTION FOR THE G/J TUBE BROKE. THE ENFIT CONNECTOR FELL OUT OF THE Y-SITE. THE CONNECTOR IS SUPPOSED TO BE SECURED IN PLACE WITH GLUE FROM MANUFACTURER. THE PATIENT RECEIVES TOTAL ENTERAL NUTRITION (TEN) OVERNIGHT WITH INSULIN COVERAGE PRIOR. THE INSULIN COVERAGE ADMINISTERED PER ORDER AND THE TEN STARTED AND LATER IT WAS OBSERVED THAT THE TEN WAS LEAKING FROM THE Y-SITE. THE PATIENT WITH SYMPTOMATIC HYPOGLYCEMIA TO 30'S (DIAPHORETIC). D50 WAS ADMINISTERED AND THE Y-SITE REPLACED, AND TEN RESTARTED. THE PROVIDER WAS MADE AWARE. THE BLOOD GLUCOSE RECOVERED; NO FURTHER INTERVENTION WAS REQUIRED. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2024 THE PATIENT¿S 30¿S BLOOD GLUCOSE LEVEL AND SUBSEQUENT TREATMENT OF ADMINISTERING THE D50 WAS A RESULT OF THE LEAKING/DISCONNECTED ENFIT CONNECTOR. THE PATIENT IS DIABETIC.
Patient problems: Hypoglycemia
MAUDE report 19454706 ↗MalfunctionMay 8, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED LEAKING AT PROXIMAL END OF CONNECT SITE; BROKEN SETS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16888604 ↗MalfunctionOct 28, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE EXTENSION SET TUBING IT IS LEAKING. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10750257 ↗MalfunctionSep 29, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT FEED WAS LEAKING FROM THE EXTENSION SET TUBING. THE ISSUE WAS DISCOVERED WHEN THE EXTENSION SET WAS DONNED BEFORE GOING TO THE PATIENT'S ROOM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10602732 ↗
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- Kangaroo 383400Cardinal Health, Inc. · Pump, Infusion, Enteral1 death659 reports
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- 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 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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