Kangaroo 77100FDRecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10884521190825), received between Oct 4, 2017 and Mar 3, 2025 — classified as 35 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (21 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

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2025Failure to Prime; Air/Gas in Device; Failure to Prime; Air/Gas in Device

  THE CUSTOMER STATED THE PATIENT REPORTED APPROXIMATELY 8-12 KANGAROO CONNECT PUMP FEEDING SETS, ALL FROM THE SAME LOT NUMBER, WILL NOT PRIME DESPITE TROUBLESHOOTING AND SUGGESTIONS FROM THE HOME ENTERAL NUTRITION NURSES. WHEN THE PATIENT ATTEMPTED TO PRIME FORMULA THROUGH THE FEEDING SET, THE FORMULA STOPPED APPROXIMATELY 2-3 INCHES INTO THE TUBING FROM THE BAG, AND AFTER A FEW SECONDS, THE FORMULA IS PULSING IN THE TUBING, AND THE PUMP ALARMS "CAUTION FEED BAG EMPTY" AS IT IS DRAWING AIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21504053 ↗
• MalfunctionDec 6, 2024Air/Gas in Device; Air/Gas in Device

  THE CUSTOMER REPORTED THE PUMP STARTED RINGING, STOPPED, AND SIGNALED A BLOCKAGE. THE CUSTOMER DIDN'T SEE ANY OBSTRUCTIONS IN THE DISPOSABLE FEEDING SET. THEY NOTICED THAT MANY TINY AIR BUBBLES WERE FORMING IN THE LIQUID IN THE TUBE AT THE PUMP "IMPELLERS" THAT MOVE THE LIQUID THROUGH THE CASSETTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20863799 ↗
• MalfunctionDec 6, 2024Air/Gas in Device; Air/Gas in Device

  THE CUSTOMER REPORTED THE PUMP SEEMED TO BE WORKING FINE FOR THE FIRST 10 MINUTES AND THEN IT STARTED RINGING, STOPPED, AND SIGNALED A BLOCKAGE. THE CUSTOMER DIDN'T SEE ANY OBSTRUCTIONS IN THE DISPOSABLE FEEDING SET. THEY NOTICED THAT MANY TINY AIR BUBBLES WERE FORMING IN THE LIQUID IN THE TUBE AT THE PUMP "IMPELLERS" THAT MOVE THE LIQUID THROUGH THE CASSETTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20863730 ↗
• MalfunctionMay 25, 2023Air/Gas in Device; Air/Gas in Device

  THE CUSTOMER REPORTED THE RN ENTERED THE PATIENT'S ROOM AND FOUND THE FEEDING TUBE LEAKING AND WITH AIR IN THE TUBING (FEED WAS COMPLETE). THERE WAS APPROXIMATELY 20ML OF FORMULA ON THE GROUND. RN LOOKED CLOSER AT THE SET AND NOTICED THE CONNECTION BETWEEN THE TUBING FROM THE BAG AND THE CONNECTION TO THE PUMP WAS NOT SEALED AND DISCONNECTED COMPLETELY AS SHE WAS INSPECTING IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17001758 ↗
• MalfunctionMay 1, 2023Air/Gas in Device; Air/Gas in Device

  THE CUSTOMER REPORTED AFTER STARTING THE SCHEDULED 11PM NG FEED, THE RN NOTICED THAT THE TUBING HAD QUITE A BIT OF AIR IN IT DESPITE APPROPRIATE PRIMING. UPON CLOSER INSPECTION, FORMULA WAS NOTED TO BE DRIPPING FROM THE BOTTOM OF THE PUMP. THE TUBING AT THE TOP OF THE CASSETTE ALSO BECAME DETACHED. THE PUMP AND FEEDING BAG WERE REPLACED AND THE FEED RESTARTED SO THERE WAS NO IMPACT TO THE PATIENT. THE OFF GOING RN REPORTED PROBLEMS WITH THE FEEDING BAG (WHICH SHE REPLACED) BUT SHE DID NOT SPECIFY WHAT THE ISSUE WAS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16846161 ↗
• MalfunctionApr 14, 2023Detachment of Device or Device Component; Air/Gas in Device; Detachment of Device or Device Component; Air/Gas in Device

  CUSTOMER REPORTS: I ENTERED THE PATIENT'S ROOM AND FOUND THE FEEDING TUBE LEAKING AND WITH AIR IN THE TUBING (FEED WAS COMPLETE). THERE WAS APPROXIMATELY 20ML OF FORMULA ON THE GROUND. I LOOKED CLOSER AT THE SET AND NOTICED THE CONNECTION BETWEEN THE TUBING FROM THE BAG AND THE CONNECTION TO THE PUMP WAS NOT SEALED AND DISCONNECTED COMPLETELY AS I WAS INSPECTING IT. THIS IS AT LEAST THE THIRD INSTANCE OF A KANGAROO CONNECT FEEDING SET LEAKING LIKE THIS THAT I HAVE HEARD ABOUT. I NOTIFIED THE CHARGE NURSE, BAGGED THE ITEM, AND LEFT IT ON THE DESK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16746701 ↗
• MalfunctionMar 28, 2023Air/Gas in Device; Air/Gas in Device

  THE CUSTOMER REPORTED THAT IN THE EVENING THEY CONNECTED AN ENTERAL FEEDING BAG TO THE PUMP, HIT AUTO PRIME AND CAME BACK TO THE PUMP TO FIND THAT ALL FORMULA PAST THE CASSETTE HAD LEAKED ONTO THE FLOOR LEAVING THE TUBING FULL OF AIR. THEY THEN HELD TO PRIME AND PLACED THE CAP ON THE END OF THE TUBING. WHEN THEY CAME BACK TO THE FEEDING PUMP THE FEED HAD AGAIN EXITED THE TUBING. ASSUMING THIS WAS OPERATOR ERROR, THEY HELD TO PRIME AGAIN TO CLEAR THE AIR AND IMMEDIATELY CONNECTED THE PRIMED TUBING TO THE PATIENT'S J-TUBE. WHILE ATTACHED (PRIOR TO STARTING THE FEEDS) THE FEED BEGAN GRAVITY FEEDING INTO THE PATIENT LEAVING AIR IN THE TUBING BETWEEN THE CASSETTE AND THE PATIENT. THE CUSTOMER STATED THAT THEY THEN GAVE UP, SEQUESTERED THE BAG AND RE-PRIMED A DIFFERENT BAG (THE OLD STYLE WITH THE ADAPTER ON THE END). ZERO ISSUES OCCURRED WITH THE NEW BAG, WHICH MAKES THEM BELIEVE IT WAS A BAG ERROR AND NOT A PUMP/OPERATOR ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16629119 ↗
• MalfunctionMar 6, 2023Air/Gas in Device; Air/Gas in Device

  PER CUSTOMER, A 6-YEAR-OLD FEMALE PATIENT WAS HOOKED UP TO CONTINUOUS FEEDS ALL NIGHT. THE PATIENT WAS BEING TREATED FOR FEVER. DURING MORNING BEDSIDE REPORT, IT WAS NOTICED THAT THE FEEDING BAG WAS LEAKING FORMULA AND LETTING AIR INTO THE TUBING. IT SEEMS LIKE THERE WAS A LITTLE HOLE WHERE THE TUBING MEETS THE PLASTIC CASSETTE THAT ATTACHES TO THE PUMP. THE CUSTOMER REPLACED IT WITH ANOTHER BAG AND THERE WAS NO LEAKING WITH THAT BAG. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16490615 ↗
• MalfunctionFeb 27, 2023Air/Gas in Device; Air/Gas in Device

  THE CUSTOMER REPORTED THAT THE NURSE (RN) NOTICED A LARGE AIR BUBBLE COMING FROM THE CANNISTER, WHICH MEASURED 99CM (26 INCHES) AND A SECOND AIR BUBBLE AT THE BASE OF THE TUBE TOWARDS THE PATIENT, WHICH MEASURED 12 CM (4 3/4 INCHES). THE RN STOPPED THE FEEDING PUMP, OBTAINED NEW EQUIPMENT AND FEEDING BAG, AND STARTED THE SET UP WITH NEW EQUIPMENT. THIS RN UPDATED THE LEAVING EVENING RN ABOUT DEFECT FOUND IN AIR BAG. SHE MENTIONED THAT SHE NOTICED AN AIR BUBBLE EARLIER AND REPRIMED THE LINE. THE RN TOLD HER OF PREVIOUS EXPERIENCE AND THE STEPS TO BE TAKEN IF SHE ENCOUNTER THIS SITUATION AGAIN. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16443594 ↗
• MalfunctionFeb 21, 2023Air/Gas in Device; Air/Gas in Device

  THE CUSTOMER REPORTED THAT THE REGISTERED NURSE (RN) WENT INTO THE ROOM AFTER THE SHIFT REPORT TO CHECK ON A PATIENT AND FEEDING PUMP CONNECTIONS. THE RN NOTICED A LARGE AIR BUBBLE COMING FROM CANNISTER, WHICH MEASURED 99 CM (26 INCHES) AND A SECOND AIR BUBBLE AT THE BASE OF THE TUBE TOWARDS PATIENT, WHICH MEASURED 12 CM (4 3/4 INCHES). THE RN STOPPED THE FEEDING PUMP, OBTAINED A NEW EQUIPMENT AND FEEDING BAG AND STARTED SET-UP WITH NEW EQUIPMENT. THE RN UPDATED THE LEAVING EVENING RN ABOUT THE ISSUE FOUND IN BAG AND SHE DID MENTION THAT SHE NOTICED AN AIR BUBBLE EARLIER AND RE-PRIMED THE LINE AND TOLD THE EVENING RN OF THE STEPS TO BE TAKEN IF ENCOUNTERS THE SITUATION AGAIN. THE ORIGINAL INTENDED PROCEDURE FOR THIS PATIENT WAS FEEDING. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16410264 ↗
• MalfunctionFeb 7, 2023Air/Gas in Device; Air/Gas in Device

  CUSTOMER REPORTS: THE RN WENT INTO THE ROOM TO CHECK ON THE PATIENT. THE PATIENT IS ON CONTINUOUS FEEDS VIA J-TUBE, INFUSING AT 75 ML/HR. THIS RN WAS GOING TO REFILL BAG WHEN SHE NOTICED THAT THERE WAS AN AIR POCKET IN THE TUBING THAT WAS ABOVE THE CARTRIDGE AND ABOUT 8" BELOW CARTRIDGE. THE RN DISCOVERED THAT THE FORMULA WAS LEAKING OUT OF THE TUBE ONTO THE FLOOR. NO AIR APPEARED TO HAVE BEEN INFUSED INTO THE PATIENT AS THERE WAS FORMULA PRESENT IN THE DISTAL TUBE ATTACHED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16312171 ↗
• MalfunctionAug 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE FEEDING TUBE OF KANGAROO CONNECT PUMP FEEDING BAG WAS DETACHED FROM CARTRIDGE. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 10-AUG-2021 STATED THAT LEAKING OCCURRED DURING THE INCIDENT DUE TO THE DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12353985 ↗
• MalfunctionAug 18, 2021Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTS: WHEN THE FEED BAG OF THE FEEDING SET WAS FILLED WITH FORMULA AND THE PUMP WAS ABOUT TO START PRIMING, THE FORMULA LEAKED FROM THE CASSETTE FIT WITH THE PUMP. UPON CHECKING THE PRODUCT IN QUESTION, IT WAS FOUND THAT THE UPSTREAM TUBE WAS NOT FIT IN PLACE, THUS UNUSABLE. THE DURATION OF USE WAS 1 DAY.

  Patient problems: Insufficient Information

  MAUDE report 12337378 ↗
• MalfunctionMay 11, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT A NURSE STATED THAT THE TUBING CAME OUT OF THE CASSETTE ON A SATURDAY DAY SHIFT AND WAS DRIPPING ONTO THE FLOOR.

  Patient problems: Insufficient Information

  MAUDE report 11806438 ↗
• MalfunctionApr 14, 2021Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THEY FOUND THE FEEDING SET TUBING ON THE FLOOR. THE SET CAME APART FROM THE WELDED CONNECTION THAT GOES INTO THE CASSETTE CAUSING LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11666880 ↗
• MalfunctionMar 16, 2021Air/Gas in Device; Air/Gas in Device

  PER CUSTOMER, A MOTHER COMPLAINED THERE WAS AIR IN THE TUBING OF THE BAGS. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11496270 ↗
• MalfunctionFeb 19, 2021Air/Gas in Device; Air/Gas in Device

  THE CUSTOMER REPORTED THAT DURING THE MORNING ASSESSMENT THE RN NOTED A SIGNIFICANT AMOUNT OF AIR IN THE TUBING. THE RN REPRIMED THE TUBING AND RECONNECTED IT TO THE PATIENT. ABOUT AN HOUR LATER IT HAD SUCKED AIR IN THROUGH THE LINE AGAIN. THEY REPLACED THE BAG AND TUBING AND EXAMINED THE OLD CLIP AND TUBING TO SEE IF THERE WAS A TEAR OR HOLE AND WHEN THEY DID THAT, THE TUBING CAME DISCONNECTED COMPLETELY FROM THE CLIP MECHANISM. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11348817 ↗
• MalfunctionAug 27, 2020Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTS: THE TUBING IS LEAKING AT THE LOCATION OF THE ADAPTER CONNECTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10462720 ↗
• MalfunctionJul 9, 2020Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  THE CUSTOMER STATED THE PATIENT'S MOTHER CALLED REGARDING THE KANGAROO CONNECT FEEDING SET. THE TUBING THAT EXITS THE PUMP BENDS AND BREAKS EASILY CAUSING THE FEED TO LEAK. THERE WAS AN ACTUAL DETACHMENT FROM THE PLASTIC CASSETTE ITSELF. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10250615 ↗
• MalfunctionApr 22, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE SET WAS LEAKING. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9987809 ↗
• MalfunctionApr 20, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE FEEDING SET LEAKED WHILE OPERATING. THE FEED LEAKED ALL OVER THE PUMP AND FLOOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9978107 ↗
• MalfunctionFeb 11, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT NOT LONG AFTER STARTING THE FEED IT BEGAN LEAKING FROM THE CARTRIDGE INSERTED INTO THE PUMP. THERE WERE NO PATIENT OR STAFF CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9693600 ↗
• MalfunctionFeb 3, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE SET HAD A BROKEN BAG AND BROKEN TUBE AT THE CASSETTE SITE. THE MILK SPILLED ON THE FLOOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9661298 ↗
• MalfunctionJan 7, 2020Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE FEEDING BAG BROKE AT THE JOINT WHERE THE TUBE GOES INTO THE CARTRIDGE AND LEAKING OCCURRED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9557691 ↗
• MalfunctionJan 6, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THE FEEDING SETS WERE LEAKING DURING FEEDING WHICH CAUSED AN UNKNOWN VOLUME OF FEED (BREAST MILK) TO BE LOST.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9555203 ↗