Kangaroo 8884721252ERecalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 10884521583030), received between Jun 7, 2017 and Dec 1, 2025 — classified as 7 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (26 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 68 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2025Break; Break

  THE CUSTOMER REPORTED A HOLE/BREAKAGE IN THE TUBING. PER ADDITIONAL INFORMATION PROVIDED ON 30NOV2025, THE ISSUE WAS DISCOVERED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23687278 ↗
• MalfunctionNov 3, 2025Difficult to Remove; Difficult to Remove

  THE CUSTOMER REPORTED PRIOR TO INSERTING THE NG TUBE, THEY FLUSHED THE TUBE WITH WATER. AFTER THE TUBE WAS IN THE CORRECT PLACE, INSIDE THE STOMACH/DUODENUM, THEY ATTEMPTED TO REMOVE THE WIRE. AT THIS POINT, IT WAS STUCK AND WOULD NOT COME OUT. WHEN THE RADIOLOGIST TRIED AGAIN THE PURPLE CAP ON TOP OF THE WIRE POPPED OFF AND THE WIRE CUT THROUGH HIS GLOVE AND LACERATED HIS RIGHT THUMB. THE THUMB WAS CLEANED WITH ALCOHOL AND A BAND-AID WAS APPLIED. AN OCC HEALTH VISIT MAY BE REQUIRED. PER ADDITIONAL INFORMATION PROVIDED BY THE REPORTER ON 03NOV2025, THIS INCIDENT OCCURRED SOME TIME AGO, BUT TO THE BEST OF THEIR RECOLLECTION THEY APPLIED A BANDAGE TO THE RADIOLOGIST'S THUMB AND COMPLETED A HOSPITAL INCIDENT REPORT. THE RADIOLOGIST SUBSEQUENTLY SCHEDULED AN OCCUPATIONAL HEALTH APPOINTMENT, DURING WHICH HE WAS INSTRUCTED TO UNDERGO BLOODWORK. THAT WAS THE FULL EXTENT OF THE CARE AND FOLLOW UP HE RECEIVED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 23453285 ↗
• MalfunctionNov 3, 2025Difficult to Remove; Difficult to Remove

  THE CUSTOMER REPORTED WHEN THE TUBE WAS POSITIONED IN THE ESOPHAGUS, THEY TRIED TO PULL OUT THE WIRE AND IT WAS STUCK. THIS WAS EVEN AFTER FLUSHING THE TUBE AT THE BEGINNING OF THE CASE. WHEN ATTEMPTING TO PULL OUT THE WIRE A TINY BIT THE PURPLE END CAP CAME OFF EXPOSING THE WIRE UNDERNEATH WHICH RIPPED THE GLOVE OF THE RADIOLOGIST. THEY THEN HAD TO USE A KELLY CLAMP TO TRY AND PULL THE WIRE OUT SAFELY AND AVOID FINGER INJURIES. THEY HAD TO SWITCH TO A NEW TUBE AS THEY HAD NOT GOTTEN THE TUBE IN THE STOMACH YET. THE PATIENT DID RECEIVE EXTRA RADIATION THAT THEY OTHERWISE DID NOT NEED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23450572 ↗
• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT A DOBHOFF TUBE WAS INSERTED. THE PATIENT COMPLAINED OF DIFFICULTY BREATHING AND CHEST PAIN. OXYGEN SATURATION DROPPED ACUTELY DESPITE OXYGEN THERAPY; PATIENT WAS TRANSFERRED TO THE NEUROCRITICAL CARE UNIT FOR STABILIZATION. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT AS FOR THE TIMING OF THE PNEUMONIA, THE PATIENT HAD A CHEST X-RAY SHOWING NO PNEUMONIA AT 17:00 ON (B)(6) 2024. AT 13:26 ON (B)(6) AFTER THE TUBE WAS REMOVED, THE X-RAY SHOWED NEW PNEUMONIA IN THE LEFT LOWER LOBE, WHERE THE DOBHOFF HAD BEEN RECENTLY REMOVED. A CT CHEST DONE AT 20:00 ON THE 25TH ADDITIONALLY SHOWED A SMALL HYDROPNEUMOTHORAX IN THE LEFT LOWER LOBE AND NEEDED TO BE TRANSFERRED TO THEIR ICU FOR STABILIZATION. THE PATIENT WAS DISCHARGED AND HAS MISSED AN AMBULATORY APPOINTMENT, SO THE CUSTOMER HAS NO NEWS ON THE CURRENT STATUS OF THE PATIENT INVOLVED.

  Patient problems: Chest Pain; Dyspnea; Low Oxygen Saturation; Pneumonia; Pneumothorax

  MAUDE report 22198908 ↗
• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT AFTER A FAILED ATTEMPT TO INSERT A NASO-GASTRIC (NG) FEEDING TUBE, A NASO-ENTERIC TUBE (NE, DOBHOFF) WAS INSERTED. AFTER 30-MINUTES, THE PATIENT COMPLAINED OF DIFFICULTY BREATHING ABOVE HER BASELINE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE PATIENT WAS RADIOLOGICALLY CONFIRMED PNEUMOTHORAX SHORTLY AFTER THE ATTEMPTED INSERTION AND NEEDED TO BE TRANSFERRED TO THEIR ICU FOR STABILIZATION. THE PATIENT IS ALIVE BUT DISABLED ON (B)(6) 2024, AND HAS NOT HAD A FOLLOW-UP IN THE MUHC SINCE. PER THE CUSTOMER, THERE IS NO FURTHER INFORMATION REGARDING PATIENT'S DISABILITY AND CORRELATION WITH THE DOBHOFF TUBE IN THE MEDICAL DOCUMENTATION FROM THAT APPOINTMENT.

  Patient problems: Dyspnea; Pneumothorax

  MAUDE report 22197827 ↗
• MalfunctionSep 23, 2024Material Separation; Material Separation

  THE CUSTOMER REPORTED THE PATIENT PULLED OUT THE NG TUBE. THE RADIOPAQUE TIP WAS MISSING WHEN REMOVED. A NEW NG TUBE WAS INSERTED. X-RAY CONFIRMED AND NOTED TO HAVE TWO RADIOPAQUE ENDS. AN OGD (OESOPHAGO-GASTRO-DUODENOSCOPY) WITH PROCEDURAL SEDATION WAS DONE AND THE BROKEN TIP WAS RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20281652 ↗
• InjuryAug 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED WHEN THE DOBHOFF TUBE WAS REMOVED FROM THE PATIENT, THE METAL END TIP DISCONNECTED FROM THE TUBE AND REMAINED INSIDE THE PATIENT'S STOMACH. THE TIP OF THE TUBE WAS REMOVED VIA AND EGD (ESOPHAGOGASTRODUODENOSCOPY).

  Patient problems: Foreign Body In Patient

  MAUDE report 20031002 ↗
• InjuryJan 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED WHEN THE PROBE WAS INSERTED, THE WEIGHTED TIP CAME LOOSE. THE TIP REMAINED IN THE PATIENT'S SINUS WITH NO POSSIBILITY OF REMOVAL AT THE TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 18484211 ↗
• MalfunctionAug 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE DOCTOR WAS INSERTING THE NASOGASTRIC TUBE AND WHEN HE WENT TO REMOVE THE STYLET THE PURPLE END CAME OFF AND THE WIRE STRUCK THE DOCTOR IN THE FINGER PIERCING THE GLOVE. THE DOCTOR WAS OK, NO INJURY OCCURRED. ADDITIONAL INFORMATION RECEIVED ON 21AUG2023 STATED THAT THE NASOGASTRIC TUBE WAS NOT FLUSHED WITH WATER PRIOR TO STYLET REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17627861 ↗
• MalfunctionJul 6, 2023Material Separation; Material Separation

  THE CUSTOMER REPORTED WHEN OPENING OF THE PACKAGE, THE RADIOPAQUE TIP OF THE DEVICE DETACHED FROM THE PROBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17265935 ↗
• MalfunctionJun 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THEY HAVE EXPERIENCED QUALITY ISSUES WITH THE PRODUCT, AS THE PRODUCT BROKE. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE PURPLE TIP WHERE THE SYRINGE SCREWS IN, BROKE OFF. THIS HAS HAPPENED TWICE. THE PATIENT WAS VERY DIFFICULT TO PLACE AND HAD TO GO TO RADIOLOGY TWICE TO GET IT REPLACED CAUSING EXTRA EXPOSURE TO RADIATION. THE CUSTOMER FURTHER STATED THAT THIS HAS HAPPENED WITH THE SAME PATIENT ON NIGHT SHIFT BUT BY TWO DIFFERENT STAFF MEMBERS. THE PATIENT HAD NASOGASTRIC (NG) TUBE PLACED BY RADIOLOGY. PER CUSTOMER, FIRST ONE BROKE DURING NIGHT SHIFT, PATIENT WENT BACK TO RADIOLOGY TO HAVE ANOTHER ONE REPLACED. THE SECOND ONE BROKE ON NIGHT SHIFT ON (B)(6)2023. THE PATIENT WENT TO RADIOLOGY FOR 3RD TIME TO HAVE ANOTHER ONE PLACED AND NO MORE HAVE BROKEN SINCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17090645 ↗
• MalfunctionMay 10, 2023Difficult to Remove; Difficult to Remove

  CUSTOMER REPORTS: THEY ARE UNABLE TO REMOVE THE GUIDE FROM THE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16907254 ↗
• MalfunctionApr 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE ENFIT CONNECTION PART DISCONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16752530 ↗
• MalfunctionMar 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE ENFIT LUER LOCK END FELL OUT. PRESENTLY HELD WITH LUER LOCK FROM BAXTER IV TUBING. FEEDING TUBE WILL BE CHANGED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16645055 ↗
• MalfunctionFeb 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE ENTRIFLEX CONNECTOR WAS STRIPPED AND CAME APART (WHEN TRYING TO DISCONNECT THE FEEDING SET FROM THE FEEDING TUBE). THIS REQUIRED REPLACEMENT OF THE FEEDING TUBE. THE CONNECTOR DID NOT BREAK, RATHER IT SEEMED LIKE AN ADHESIVE FAILED POSSIBLY. WHEN THEY IMPLEMENTED THESE TUBES, A KEY PIECE OF EDUCATION WAS NOT TO OVERTIGHTEN AND THE STAFF WERE AWARE OF THIS. PER ADDITIONAL INFORMATION RECEIVED, THE PLASTIC TIP OF THE ENTRIFLEX TUBE CAME APART (I.E., STRIPPED) FROM THE ENTRIFLEX CONNECTOR RENDERING THE TUBE UNUSABLE. THERE WAS NO MEDICAL INTERVENTION REQUIRED BESIDES TUBE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16278323 ↗
• MalfunctionJan 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTS: THE ENTRIFLEX CONNECTOR WAS STRIPPED AND CAME APART WHEN TRYING TO DISCONNECT THE FEEDING SET FROM THE FEEDING TUBE WHICH REQUIRED REPLACEMENT OF THE FEEDING TUBE. THE CONNECTOR DID NOT BREAK, RATHER IT SEEMED LIKE THE ADHESIVE FAILED. WHEN WE IMPLEMENTED THESE TUBES, A KEY PIECE OF EDUCATION WAS NOT TO OVERTIGHTEN AND OUR STAFF ARE AWARE OF THIS. PER ADDITIONAL INFORMATION RECEIVED ON 1/20/23 THE TUBING DETACHED AND THE PLASTIC TIP OF THE ENTRIFLEX TUBE CAME APART I.E., STRIPPED FROM THE ENTRIFLEX CONNECTOR RENDERING THE TUBE UNUSABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16229533 ↗
• InjuryJan 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE DISTAL END OF THE CATHETER HAS BECOME DETACHED. THIS TUBE WAS INSERTED IN AN ANAESTHETIZED PATIENT (IN INTENSIVE CARE). THE INTUBATION PROBE WAS POSITIONED IN THE TRACHEA INSTEAD OF THE ESOPHAGUS. FOLLOWING THE OBSERVATION OF THE POSITIONING, DURING REMOVAL, THE DISTAL END OF THE PROBE WAS NO LONGER PRESENT VIA IMAGING CHECK. AFTER OBSERVATION (SYRINGE TEST) AND DURING REMOVAL, THE DISTAL END WAS "PINCHED" BETWEEN THE BALLOON OF THE INTUBATION PROBE AND THE TRACHEAL WALL. THE DISCONNECT OCCURRED AT THIS TIME. THE DISTAL END MIGRATED TOWARD THE STEM BRONCHUS OF THE LOWER LOBE OF THE LEFT LUNG AND WAS REMOVED VIA FIBROSCOPY. THERE WERE NO CLINICAL CONSEQUENCES FOR THIS PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16163309 ↗
• MalfunctionOct 20, 2022Separation Failure; Separation Failure

  THE CUSTOMER REPORTED IT WAS DIFFICULT, EVEN IMPOSSIBLE TO REMOVE THE GUIDE, EVEN AFTER LUBRICATING THE TUBE AND INSERTION. THE PRODUCT WAS CHECKED BEFORE USE AND IT WAS ADEQUATE. THEY TRIED ANOTHER TUBE AND HAD THE SAME PROBLEM. THERE WAS TRAUMA FOR THE BENEFICIARY. PER ADDITIONAL INFORMATION PROVIDED ON OCTOBER 19, 2022 THERE WAS NO PHYSICAL TRAUMA BUT RATHER PSYCHOLOGICAL TRAUMA RELATED TO THE REPEATED ATTEMPTS TO WITHDRAW THE GUIDE WIRE FROM THE TUBE AS WELL AS THE BACK AND FORTH MOVEMENTS OF THE TUBE IN THE NASAL WALL, THE THROAT, AND IN THE ESOPHAGUS DURING ATTEMPTS TO WITHDRAW THE GUIDE WITH THE ASSOCIATED RISKS . THE TUBE WAS FINALLY REMOVED AND ANOTHER TUBE WAS INSTALLED WITH THE SAME DIFFICULTIES. TO THEIR KNOWLEDGE THERE HAS BEEN NO MEDICAL TREATMENT/INTERVENTION.

  Patient problems: Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 15639687 ↗
• MalfunctionOct 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE PURPLE CAP/END OF THE GUIDEWIRE/STYLET CAME OFF WHEN REMOVING IT FROM THE TUBE. THEY FLUSHED WITH 10ML OF WATER PRIOR TO REMOVING THE STYLET. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15545029 ↗
• InjuryOct 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE PROBE TIP CONTAINING A 5G LOAD BROKE AWAY FROM THE KANGAROO FEEDING TUBE WHILE BEING PULLED FROM THE PATIENT. AN OPERATION WAS NECESSARY TO REMOVE THE DETACHED ELEMENT FROM THE INTESTINE. THE PATIENT WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15533449 ↗
• MalfunctionAug 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE CAP FROM GUIDEWIRE POPPED OFF ON IT'S OWN. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15285584 ↗
• MalfunctionAug 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE CAP USED TO PULL GUIDEWIRE DETACHED WHILE GUIDE WIRE BEING PULLED, THE EXPOSED WIRE WAS HOOK SHAPED AND SHARP. WHEN THE CAP CAME OFF, IT SLICED THROUGH THE REGISTERED NURSE¿S GLOVE AND SCRATCHED FINGER, DID NOT CUT FINGER OPEN BUT COULD HAVE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THERE WAS NO MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE SCRATCH.

  Patient problems: Abrasion

  MAUDE report 15285362 ↗
• MalfunctionJun 21, 2022Difficult to Remove; Difficult to Remove

  THE CUSTOMER REPORTED THEY INSERTED A NASOGASTRIC TUBE AT 3:00 AM. THE FEEDING TUBE WAS CHECKED AT 6:00 AM. MANDRIN (GUIDEWIRE/STYLET) REMOVAL IMPOSSIBLE. THE FEEDING TUBE HAD TO BE REMOVED AND A NEW FEEDING TUBE WAS PLACED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14755046 ↗
• MalfunctionMay 31, 2022Material Puncture/Hole; Difficult to Remove; Material Puncture/Hole; Difficult to Remove

  CUSTOMER REPORTS: WHEN INSERTING A NASOGASTRIC TUBE, IT WAS IMPOSSIBLE TO REMOVE THE GUIDEWIRE. THEY HAD TO TAKE A CLAMP AND PULL VERY HARD TO REMOVE IT. BY CARRYING OUT THE CONTROL OF THE CORRECT POSITIONING WITH AN AIR SYRINGE, IMPOSSIBILITY OF PUSHING THE AIR INTO THE PROBE. SO WITHDRAWAL OF A PROBE AND INSTALLATION OF A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14548229 ↗
• MalfunctionMay 5, 2022Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE TUBE WAS POSITIONED IN THE STOMACH AND WHEN PULLING OUT THE WIRE, THE PURPLE CAP POPPED OFF REVEALING THE "FISH HOOK" WIRE UNDERNEATH. THIS WAS EVEN AFTER FLUSHING THE TUBE AT THE BEGINNING OF THE CASE. OFTEN A KELLY CLAMP IS USED TO TRY AND PULL THE WIRE OUT ONCE THE TUBE IS IN PLACE. THE CUSTOMER ALSO REPORTED THAT THESE TUBES LEAK AT THE TOP AND THE "Y" JUNCTIONS CRACKS ALL THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14286554 ↗