Kangaroo 60ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 20884521143910), received between Oct 19, 2017 and Jan 26, 2022 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2022Obstruction of Flow; Obstruction of Flow

  CUSTOMER REPORTS: NURSING ATTEMPTED TO PRIME THE EXTENSION SET BUT COULD NOT. THE TUBING IS OCCLUDED NEAR THE STEP CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13359071 ↗
• MalfunctionApr 5, 2021Complete Blockage; Complete Blockage

  THE CUSTOMER REPORTED THAT THE TUBING HAS A BLOCKAGE AT THE MALE ADAPTOR SIDE AND WILL NOT LET THE FORMULA/MILK PASS THROUGH INTO FEEING TUBE. THE CUSTOMER ALSO STATED THAT THE CONNECTION TO THE FEEDING TUBE HAS BEEN DIFFICULT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11616455 ↗
• MalfunctionMar 26, 2021Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE PEDIATRIC FEEDING EXTENSION SET PORT (60ES) DISCONNECTED FROM THE EXTENSION TUBING, LEAVING IT UNUSABLE. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 26-MAR-2021 STATED THAT THE ENTIRE PORT CAME OFF AND THERE WAS LEAKING. THE DEVICE NEEDED TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11576631 ↗
• MalfunctionAug 28, 2020Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTS: THE EXTENSION SETS ARE LEAKING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10465574 ↗
• MalfunctionAug 28, 2020Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTS: THE EXTENSION SET IS LEAKING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10465332 ↗
• MalfunctionMay 12, 2020Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT THE INFANT WAS BEING PLACED BACK IN ISOLETTE AFTER DOING SKIN TO SKIN WITH THE INFANT ON THE MATTRESS AND THE PURPLE CAPPED TIP OF THE MICROBORE EXTENSION SET SEPARATED. THE EXTENSION SET WAS PROMPTLY DISCONNECTED AND REPLACED. THERE WERE NO ADDITIONAL TREATMENTS REQUIRED OTHER THAN REPLACING THE EXTENSION SET. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10049182 ↗
• MalfunctionApr 20, 2020Complete Blockage; Complete Blockage

  THE CUSTOMER REPORTED THAT THE TUBING WAS MELTED AND WELDED SHUT. IT DID NOT ALLOW ANY FLOW THROUGH THE TUBE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9977440 ↗
• MalfunctionApr 2, 2020Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT WHEN THE PACKAGING OF THE EXTENSION KIT WAS OPENED, THE TUBING WAS FOUND TO BE CUT IN SEVERAL PIECES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9916426 ↗
• MalfunctionFeb 28, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE DEVICE WAS LEAKING BETWEEN THE TUBING AND THE CONNECTOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9771024 ↗
• MalfunctionJul 31, 2019Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THE MICROBORE EXTENSION SET WOULD NOT WORK. THE FEED WAS NOT RECEIVED FOR THE PATIENT WHEN IT WAS ATTACHED TO THE PUMP OR WHEN BEING MANUALLY PUSHED WITH A SYRINGE. THE PATIENT WAS EITHER FED USING A DIFFERENT EXTENSION SET OR SYRINGE FED THROUGH THE FEEDING TUBE. THERE WAS NO OTHER MEDICAL INTERVENTION NEEDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8845805 ↗
• MalfunctionJul 30, 2019Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THE MICROBORE EXTENSION SET WOULD NOT WORK. THE FEED WAS NOT RECEIVED FOR THE PATIENT WHEN IT WAS ATTACHED TO THE PUMP OR WHEN BEING MANUALLY PUSHED WITH A SYRINGE. THE PATIENT WAS EITHER FED USING A DIFFERENT EXTENSION SET OR SYRINGE FED THROUGH THE FEEDING TUBE. THERE WAS NO OTHER MEDICAL INTERVENTION NEEDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8843222 ↗
• MalfunctionJul 24, 2019Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THE EXTENSION SET WAS OCCLUDED. WHEN THE DEVICE WAS ATTACHED TO THE SYRINGE PUMP IT WOULD NOT RECEIVE THE FEEDING. THERE WAS NO HARM TO THE PATIENT; A NEW SET WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8821818 ↗
• MalfunctionMay 23, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE FEEDING WAS NOTED TO BE DRIPPING OUT OF THE FEEDING TUBE EXTENSION SET, LEAKING INTO THE BED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8638128 ↗
• MalfunctionMay 20, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED AFTER PRIMING, THE FEEDING TUBE WAS LEAKING BETWEEN THE TUBING AND THE CONNECTOR. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8625239 ↗
• MalfunctionOct 19, 2017Obstruction of Flow; Obstruction of Flow

  ACCORDING THE REPORTER, ON( B)(6) 2017, DURING PROCEDURE, THE LINE OF THE PRODUCT WAS BLOCKED. PATIENT OUTCOME WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6963455 ↗