Kangaroo 60ENS (UDI 10884521212084)Recalls & reported problems
Cardinal Health, Inc. · Extension Set · 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 10884521212084), received between Oct 23, 2020 and Feb 27, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Puncture/Hole” (2 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
- Material Puncture/Hole2
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2023Material Puncture/Hole; Material Puncture/Hole
THE CUSTOMER REPORTED THE KANGAROO EXTENSION TUBING SET WAS FOUND TO BE LEAKING FROM THE TUBING AND NOT FROM THE CONNECTION. NO PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED ON 23FEB2023 STATED THAT THE DEVICE LEAKED FROM THE TUBING NEAR THE PORT OF THE EXTENSION SET THROUGH A PERFORATION IN THE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16443927 ↗MalfunctionFeb 27, 2023Material Puncture/Hole; Material Puncture/Hole
THE CUSTOMER REPORTED THE KANGAROO EXTENSION TUBING SET WAS FOUND TO BE LEAKING FROM THE TUBING AND NOT FROM THE CONNECTION. NO PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED ON 23FEB2023 STATED THAT THE DEVICE LEAKED FROM THE TUBING NEAR THE PORT OF THE EXTENSION SET THROUGH A PERFORATION IN THE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16443918 ↗MalfunctionOct 23, 2020Obstruction of Flow; Obstruction of Flow
THE CUSTOMER REPORTED THEY WENT TO USE THE EXTENSION TUBE AND COULD NOT PUSH AIR THRU THE TUBE, THE TUBE WAS BLOCKED. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10727814 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.