Kangaroo 461243E (UDI 20884521742229)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 20884521742229), received between Jul 8, 2019 and May 9, 2023 — classified as 4 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (10 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2023Break; Break

  THE CUSTOMER REPORTED THAT AN ELDERLY FEMALE PATIENT WAS BROUGHT TO THE EMERGENCY DEPARTMENT. IT WAS NOTED THAT THE PATIENT HAD LIKELY LOST 15 KG OF WEIGHT IN THE PAST TWO MONTHS. SHE WAS ADMITTED TO THE UNIT THE NEXT DAY. NINE DAYS LATER, THE PHYSICIAN ORDERED A FEEDING TUBE BE PLACED. AT 1400, THE FEEDING TUBE WITH IRIS TECHNOLOGY WAS PLACED VIA THE LEFT NARE BY A NURSE FROM THE NEUROLOGICAL UNIT. THE FIRST PLACEMENT CONFIRMATION CHEST X-RAY SHOWED THE ¿ENTERIC TUBE COURSES BEYOND THE DIAPHRAGM AND FIELD-OF-VIEW.¿ THE RADIOLOGIST NOTIFIED THE DAYSHIFT RN THAT THE TUBE NEEDED TO BE PULLED BACK. THE NEURO RN CAME BACK TO THE UNIT AND PULLED THE TUBE BACK ABOUT 5 CM. A SECOND-PLACE CONFIRMATION ABDOMINAL X-RAY WAS OBTAINED LATER THAT DAY, SHOWING THE ¿ENTERIC TUBE WITH TIP IN THE DISTRIBUTION OF THE STOMACH.¿ THE PHYSICIAN WROTE THE ¿OKAY TO USE¿ ORDER AFTER THIS. THE FEEDING TUBE WAS DOCUMENTED AS BEING AT 52 CM AND SECURED WITH A NASAL BRIDLE. TUBE FEEDING WAS STARTED THAT NIGHT VIA THE SIDE PORT. TWENTY DAYS POST THE INITIAL ED VISIT, THE FEEDING TUBE WAS NOTICED TO BE BROKEN. AT THE SAME TIME, IT WAS NOTICED THAT THE STYLET WAS STILL WITHIN THE FEEDING TUBE. THE BROKEN TUBE WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16894073 ↗
• MalfunctionApr 14, 2023Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED THAT THE IRIS NASOGASTRIC TUBE CONTINUES TO BREAK AND IS A DEFECTIVE PRODUCT. THE PATIENT CONTINUE TO EXPERIENCE MALFUNCTIONS, LEAKS, BREAKS, AND DEFECTS IN THIS MEDICAL EQUIPMENT. ON THE DAY OF THIS INCIDENT, WHEN ATTEMPTING TO ADMINISTER MEDICATIONS, THE PLASTIC END OF THE NASOGASTRIC TUBE FELL APART IN THE NURSE'S HAND, WITHOUT PRESSURE OR WITHOUT FULLY CONNECTING A SYRINGE TO ANY PORT. THERE WAS NO PATIENT INJURY REPORTED. PER ADDITIONAL INFORMATION RECEIVED, THE DEFECTIVE FEEDING TUBE WAS REMOVED AND A NEW FEEDING TUBE PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16745823 ↗
• MalfunctionMar 15, 2023Break; Break

  THE CUSTOMER REPORTED THAT THE NASAL GASTRIC TUBE (NGT) IS MADE OF PLASTIC THAT IS NOT ROBUST AND IT FELL APART IN THEIR HANDS WHEN ATTEMPTING TO ADMINISTER MEDICATIONS. THE TUBE MUST BE REPLACED AND THEREFORE EXPOSES THE PATIENT TO UNNECESSARY RISK. ALTHOUGH THIS DEVICE REPORTEDLY LOWERS THE RISK OF CAUSING PATIENT HARM DURING INSERTION BY UTILIZING IRIS CAMERA TECHNOLOGY, IT IS NOT ROBUST ENOUGH TO WITHSTAND REPEATED USE AND APPEARS TO HAVE BROKEN. THE DECREASED RISK ASSOCIATED WITH INSERTION OF NG TUBES WITH CAMERAS IS A MOOT POINT IF THE TUBE EASILY BREAKS AND HAS TO BE REINSERTED. THE PROBABILITY OF CAUSING PATIENT HARM INCREASES EXPONENTIALLY IF THE PATIENT MUST UNDERGO REPEATED INSERTIONS DUE TO TUBES BREAKING DUE TO INSUFFICIENT DESIGN. IT IS THE BELIEF OF THIS RN THAT THIS DESIGN IS NOT SUFFICIENT TO WITHSTAND STANDARD OPERATION OVER A DURATION THAT MOST PATIENTS MUST TOLERATE, AND THEREFORE SUBJECTS THE PATIENTS TO INCREASED RISK OF HARM DUE TO TUBES HAVING TO BE REPLACED DUE TO BREAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16545195 ↗
• MalfunctionFeb 23, 2023Break; Structural Problem

  NGT IS MADE OF PLASTIC THAT IS NOT ROBUST AND FELL APART IN THIS RN'S HANDS WHEN ATTEMPTING TO ADMINISTER MEDICATIONS. TUBE MUST BE REPLACED AND THEREFORE EXPOSES PATIENT TO UNNECESSARY RISK RELATED TO REPLACEMENT OF NGT, INCLUDING DISCOMFORT, POSSIBLE TRAUMA, DEATH, PNEUMOTHORAX, LONG LENGTH OF STAY, SEPSIS, PNEUMONIA AND OTHER. ALTHOUGH THIS DEVICE REPORTEDLY LOWERS THE RISK OF CAUSING PATIENT HARM DURING INSERTION BY UTILIZING IRIS CAMERA TECHNOLOGY, IT IS NOT ROBUST ENOUGH TO WITHSTAND REPEATED USE AND APPEARS TO HAVE BROKEN. THE DECREASED RISK ASSOCIATED WITH INSERTION OF NG TUBES WITH CAMERAS IS A MOOT POINT IF THE TUBE EASILY BREAKS AND HAS TO BE REINSERTED. THE PROBABILITY OF CAUSING PATIENT HARM INCREASES EXPONENTIALLY IF THE PATIENT MUST UNDERGO REPEATED INSERTIONS DUE TO TUBES BREAKING DUE TO INSUFFICIENT DESIGN. IT IS THE BELIEF OF THIS RN THAT THIS DESIGN IS NOT SUFFICIENT TO WITHSTAND STANDARD OPERATION OVER A DURATION THAT MOST PATIENTS MUST TOLERATE, AND THEREFORE SUBJECTS PATIENTS TO INCREASED RISK OF HARM DUE TO TUBES HAVING TO BE REPLACED DUE TO BREAKAGE. THERAPY DATES: (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16437516 ↗
• MalfunctionJul 11, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THEY WERE CALLED TO REPLACE DHT DUE TO LEAKING. THEY ARRIVED TO FIND THE TUBE FEED LINE ATTACHED TO THE DHT PORT. THAT PORT WAS CRACKED AWAY FROM THE MAIN TUBE WITH ONLY A SMALL SECTION OF PLASTIC HOLDING IT TOGETHER. THE TUBE FEEDING LINE WAS STUCK IN THE HUB AND THEY WERE UNABLE TO DISCONNECT IT FROM THE DHR. THE OLD DHT AND BRIDLE WAS REMOVED AND A NEW DHT WAS PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14977271 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THE COVIDIEN KANGAROO FEEDING TUBE WITH IRIS TECHNOLOGY ERODED THROUGH THE PATIENT'S STOMACH AND TRANSVERSE COLON CAUSING SEPTIC SHOCK AND NEED FOR EMERGENT SURGERY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Erosion; Septic Shock

  MAUDE report 14702290 ↗
• InjuryMay 16, 2022Migration or Expulsion of Device

  COVIDIEN KANGAROO FEEDING TUBE WITH IRIS TECHNOLOGY ERODED THROUGH PATIENT STOMACH AND TRANSVERSE COLON CAUSING SEPTIC SHOCK AND NEED FOR EMERGENT SURGERY. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Erosion; Septic Shock

  MAUDE report 14416274 ↗
• MalfunctionMar 11, 2022Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER STATED THE IRIS TUBE WAS CLOGGED AT THE DISTAL END ABOVE THE CAMERA AND THEY WERE NOT ABLE TO DISLODGE THE CLOG USING A CLOG ZAPPER ALONG WITH THE GUIDE WIRE. IT ALSO HAS A PIN SIZED HOLE AT THE PURPLE "Y" CONNECTION. THE TUBE WAS REMOVED AND REPLACED WITH ANOTHER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13731962 ↗
• MalfunctionDec 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE IRIS FEEDING TUBE WAS LEAKING AT THE ENDS OF THE MAIN PORT AND THEY SAW A TEAR IN THE PURPLE END OF THE FEEDING TUBE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12960916 ↗
• InjuryAug 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT THEY HAD AN UNFORTUNATE INCIDENT WITH AN NJ TUBE PLACEMENT USING THE KANGAROO IRIS. DURING INSERTION ON THE NIGHT SHIFT, THE PATIENT EXPERIENCED A PNEUMOTHORAX AND REQUIRED A CHEST TUBE PLACEMENT. THE IRIS FEEDING TUBE WAS PROPERLY CONNECTED TO THE CONSOLE AT THE TIME OF PLACEMENT. ACCORDING TO THE CUSTOMER'S RECORDS, THE NURSE WAS NOT PREVIOUSLY TRAINED OR CERTIFIED TO PLACE IRIS TUBES PER THEIR COMPETENCY REQUIREMENTS. THE NURSE DID NOT STOP AT THE 30CM TO VISUALIZE ANY OF THE ANATOMY (TRACHEA, CARINA) BUT DID CONSULT WITH ANOTHER UNIT RN WHO APPARENTLY WAS CHECKED OFF. THE PATIENT WAS ALREADY INTUBATED AT THE TIME OF THE EVENT. IT IS UNKNOWN IF THE PATIENT HAD ANY KNOWN RESPIRATORY ABNORMALITIES. THIS EVENT OCCURRED IN THE (B)(6).

  Patient problems: Pneumothorax

  MAUDE report 12392297 ↗
• MalfunctionJun 21, 2021Break; Break

  THE CUSTOMER REPORTED THAT THE IRIS FEEDING TUBE BROKE AT THE ENFIT PORT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12032917 ↗
• MalfunctionJun 21, 2021Fracture; Fracture

  THE CUSTOMER REPORTED THAT THE NJ TUBE CRACKED AT THE ENFIT PORT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12032631 ↗
• MalfunctionJun 21, 2021Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT THE ENFIT PORT ON THE IRIS FEEDING TUBE DISCONNECTED FROM THE TUBE IN MICU. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12032514 ↗
• MalfunctionJun 21, 2021Material Separation; Obstruction of Flow; Material Separation; Obstruction of Flow

  THE CUSTOMER REPORTED THAT THE IRIS FEEDING TUBE WAS CRACKED AND CLOGGED. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION PROVIDED ON JUNE 16, 2021 STATED THAT IT WAS THE ENFIT Y-PORT THAT CRACKED AND THE HARD PLASTIC OF THE ENFIT THREADS DETACHED FROM THE SOFT RUBBER Y PIECE. TO RESOLVE THE ISSUE THE FEEDING TUBE WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12032321 ↗
• MalfunctionMar 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE TUBE BROKE AT Y JUNCTION. THERE WAS LEAKING OBSERVED WHEN THE FEEDING TUBE FLUSHED AFTER GIVING MEDICATION AND WITH TUBE FEEDING RUNNING. NO PATIENT HARM REPORTED OTHER THAN DISCOMFORT AND INCONVENIENCE OF REPLACING THE FEEDING TUBE EARLIER THAN NECESSARY. THE FEEDING TUBE WAS PLACED ON (B)(6) 2021.

  Patient problems: Discomfort

  MAUDE report 11553396 ↗
• MalfunctionMar 23, 2021Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE FEEDING TUBE BROKE AT THE Y-PORT AND THE PURPLE PORT COMING RIGHT OFF. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER STATED THAT THE TUBE BROKE OFF AT THE PURPLE CAP CONNECTION AND CAN¿T BE RECONNECTED. THERE WAS LEAKING OBSERVED WHEN THE FEEDING TUBE FLUSHED AFTER GIVING MEDICATION AND WITH TUBE FEEDING RUNNING. NO PATIENT HARM REPORTED OTHER THAN DISCOMFORT AND INCONVENIENCE OF REPLACING THE FEEDING TUBE EARLIER THAN NECESSARY. THE FEEDING TUBE WAS PLACED ON (B)(6) 2021.

  Patient problems: Discomfort

  MAUDE report 11553215 ↗
• MalfunctionMar 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE TUBE BROKE AT Y JUNCTION. THERE WAS LEAKING OBSERVED WHEN THE FEEDING TUBE FLUSHED AFTER GIVING MEDICATION AND WITH TUBE FEEDING RUNNING. NO PATIENT HARM REPORTED OTHER THAN DISCOMFORT AND INCONVENIENCE OF REPLACING THE FEEDING TUBE EARLIER THAN NECESSARY. THE FEEDING TUBE WAS PLACED ON (B)(6) 2021.

  Patient problems: Discomfort

  MAUDE report 11552817 ↗
• MalfunctionMar 18, 2021Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT A PORTION OF THE Y-PORT DETACHED DURING USE CAUSING THE FEEDING TUBE TO LEAK AT THE Y-SITE WHICH EFFECTIVELY MADE THAT PORT NON-FUNCTIONAL, MEANING THEY HAD TO REPLACE THE TUBE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11519120 ↗
• MalfunctionFeb 3, 2021Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE FEEDING TUBE WAS STUCK. THE RN TRIED TO GET IT UNSTUCK AND THE PURPLE HUB BROKE, IT EITHER CRACKED OR FULLY DETACHED. THERE WAS SOME LEAKAGE OF EITHER TUBE FEEDINGS OR MEDS. THERE WAS NO HARM DONE TO THE PATIENT BUT THE FEEDING TUBE NEEDED TO BE REINSERTED AND THE PATIENT DID EXPERIENCE DISCOMFORT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort

  MAUDE report 11276783 ↗
• MalfunctionFeb 3, 2021Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE FEEDING TUBE WAS STUCK. THE RN TRIED TO GET IT UNSTUCK AND THE PURPLE HUB BROKE, IT EITHER CRACKED OR FULLY DETACHED. THERE WAS SOME LEAKAGE OF EITHER TUBE FEEDINGS OR MEDS. THERE WAS NO HARM DONE TO THE PATIENT BUT THE FEEDING TUBE NEEDED TO BE REINSERTED AND THE PATIENT DID EXPERIENCE DISCOMFORT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort

  MAUDE report 11276782 ↗
• MalfunctionFeb 3, 2021Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE FEEDING TUBE WAS STUCK. THE RN TRIED TO GET IT UNSTUCK AND THE PURPLE HUB BROKE, IT EITHER CRACKED OR FULLY DETACHED. THERE WAS SOME LEAKAGE OF EITHER TUBE FEEDINGS OR MEDS. THERE WAS NO HARM DONE TO THE PATIENT BUT THE FEEDING TUBE NEEDED TO BE REINSERTED AND THE PATIENT DID EXPERIENCE DISCOMFORT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort

  MAUDE report 11276774 ↗
• MalfunctionDec 13, 2020Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE KANGAROO IRIS FEEDING TUBE ENFIT PORT BROKE AT THE SOFT RUBBER Y PORT HUB BELOW THE THREADS. ENTIRE THREADED PORT WAS REMOVED. THIS CAUSED LEAKING OF ENTERAL NUTRITION AND TUBE REPLACEMENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10998579 ↗
• MalfunctionSep 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE PURPLE HUB ON THE FEEDING PORT BROKE OFF. FOR A FEW DAYS IT WAS LOOSE AND THE CUSTOMER KEPT PUTTING IT BACK ON AS THEY DIDN'T REALIZE IT WASN'T A REMOVABLE PIECE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10541185 ↗
• InjuryJul 8, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTS THE IRIS TUBE WAS INSERTED INTO THE LUNG AND THE PATIENT DEVELOPED A HEMOTHORAX. THE TUBE WAS REMOVED AFTER A CHEST X-RAY AND THE PATIENT REQUIRED THE INSERTION OF A CHEST TUBE.

  Patient problems: Hemothorax

  MAUDE report 8767482 ↗