Kangaroo 8884721252Recalls & reported problems

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 10884521518919), received between Nov 9, 2017 and Aug 15, 2025 — classified as 11 injuries, 69 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (39 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 80 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2025Break; Break

  THE CUSTOMER REPORTED THAT WHEN OPENING THE STERILE PACKAGE, IT WAS OBSERVED THAT THE MATERIAL WAS TORN, OPENING A NEW MATERIAL. THIS EVENT WAS REPORTED BY ANVISA. NO CUSTOMER INFORMATION WAS PROVIDED THEREFORE ADDITIONAL INFORMATION CANNOT BE REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22816852 ↗
• InjuryAug 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE FEEDING TUBE WAS BROKEN DURING DSA PROCEDURE. UPON REMOVAL OF GUIDEWIRE, THE PLASTIC COATED METALLIC TIP OF ENTRIFLEX TUBE WAS FOUND TO BE DISLODGED FROM THE REST OF THE CATHETER. PER ADDITIONAL INFORMATION PROVIDED ON 01SEP2025, THE PATIENT WAS ADMITTED AND SENT TO HAVE AN URGENT GASTROINTESTINAL ENDOSCOPY TO REMOVE THE FOREIGN BODY.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 22815303 ↗
• InjuryAug 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT A NASOGASTRIC TUBE WAS INSERTED ON SEPTEMBER 24TH AND RELEASED FOR USE AFTER CONFIRMATION BY THE PHYSICIAN VIA X-RAY. ON A FOLLOW-UP X-RAY ON SEPTEMBER 26TH, THE PHYSICIAN VISUALIZED THE TIP OF THE TUBE IN THE ESOPHAGUS AND ORDERED AN ENDOSCOPY. ENTERAL NUTRITION WAS DISCONTINUED AND THE PATIENT WAS AWAITING ENDOSCOPY. AN ENDOSCOPY WAS PERFORMED ON SEPTEMBER 26TH, AND THE RADIOPAQUE METAL TIP WAS VISUALIZED, DETACHED FROM THE ENTERAL TUBE BODY, IN THE PATIENT'S STOMACH. ALL IMAGES ARE AVAILABLE IN THE ELECTRONIC MEDICAL RECORD. THIS EVENT WAS REPORTED BY ANVISA. NO CUSTOMER INFORMATION WAS PROVIDED THEREFORE ADDITIONAL INFORMATION CANNOT BE REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22723505 ↗
• MalfunctionAug 5, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE NASOGASTRIC TUBE RUPTURED NEAR THE BIFURCATION, REQUIRING REMOVAL AND A NEW INSERTION. A NEW INSERTION OCCURRED IN THE OPPOSITE NOSTRIL WITHOUT ANY RESISTANCE. UPON REMOVING THE RUPTURED TUBE, SHE OBSERVED THAT IT WAS NOT COMPLETELY REMOVED AND THAT THE METAL TIP WAS NOT IN A DEVICE, APPEARING TO HAVE "BURST." WHEN QUESTIONED ABOUT AN ATTEMPT TO UNBLOCK THE TUBE, SHE STATED THAT IT DID NOT OCCUR DURING HER SHIFT AND THAT THE REPLACEMENT WAS SOLELY DUE TO AN EXTERNAL RUPTURE. THEY ADVISED CONTACTING THE PRIMARY CARE TEAM TO REPORT THE INCIDENT, REQUEST AN X-RAY TO CONFIRM THE NEW TUBE INSERTION, AND ATTEMPT TO IDENTIFY THE "LOST" TIP. DR. E, FROM CLINICAL ONCOLOGY, ADVISES THAT SHE WILL REQUEST AN EVALUATION AND OPINION FROM THE ABDOMINAL SURGERY TEAM. THE PATIENT REMAINS COMFORTABLE WITH NO SIGNS OF DISCOMFORT OR AGITATION AND IS CURRENTLY UNATTENDED. NO OTHER INFORMATION IS ABLE TO BE OBTAINED AS THE EVENT WAS REPORTED ANONYMOUSLY TO ANVISA IN BRAZIL.

  Patient problems: Foreign Body In Patient

  MAUDE report 22723397 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT ENTRIFLEX PROBE MIGRATED TO THE LUNG SOON AFTER THE PROCEDURE, EVOLVING TO PNEUMOTHORAX AND IT WAS CONFIRMED THROUGH AN X-RAY IMAGE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT APPROPRIATE INTERVENTIONS FOR THE PNEUMOTHORAX WERE PERFORMED. PER CUSTOMER, IT WAS NECESSARY TO PLACE A CHEST DRAIN WITH A WATER SEAL AND RECEIVE INTENSIVE CARE TO RESOLVE THE CLINICAL CONDITION. THE TREATMENTS WERE CARRIED OUT WITH GOOD RECOVERY.

  Patient problems: Pneumothorax

  MAUDE report 22386752 ↗
• InjuryJan 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED IN AN ATTEMPT TO INSTALL THE 12FR ENTERAL FEEDING TUBE IN THE PATIENT, WHEN REMOVING THE GUIDE WIRE, THE NURSE SHOWED THAT THE GUIDE WIRE HAD POSITIONED THE PROBE, REQUIRING REMOVAL AND A NEW ATTEMPT TO PASS IT. WHEN REMOVING THE PROBE, IT WAS OBSERVED THAT THE TIP RADIOPAQUE PART OF THE DEVICE DETACHED, BECOMING LODGED IN THE PATIENT'S LUNG. AN IMAGING EXAM WAS PERFORMED TO CONFIRM POSITIONING.

  Patient problems: Foreign Body In Patient

  MAUDE report 21114800 ↗
• MalfunctionAug 6, 2024Material Rupture; Material Rupture

  THE CUSTOMER REPORTED SNE RUPTURE NEAR THE BIFURCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19923817 ↗
• MalfunctionJun 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE TUBE WAS INSERTED INTO THE PATIENT AND THE STYLET WIRE WAS DISCARDED. THE WIRE PUNCTURED THE DOCTOR'S THUMB DURING REMOVAL. ADDITIONAL INFORMATION RECEIVED STATED THE GREEN CAP COVERING THE END OF THE WIRE FELL OFF AND THE WIRE PUNCTURED THE DOCTOR'S THUMB. THE DOCTOR LEFT THE CASE, WASHED HIS HANDS, AND APPLIED A BAND AID.

  Patient problems: Needle Stick/Puncture

  MAUDE report 17078245 ↗
• MalfunctionFeb 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE TIP OF THE MANDREL (GUIDE WIRE) CAME OFF AND PIERCED AN EMPLOYEE'S FINGER. IT IS THE THIRD OCCURRENCE WITH THE SAME BATCH OF THIS SNE. THE MATERIAL WAS USED ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS, BUT THE PROBLEM CONTINUES TO OCCUR.

  Patient problems: Needle Stick/Puncture

  MAUDE report 16382295 ↗
• MalfunctionJan 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE FEEDING TUBE INSERTION PROCEEDED ON (B)(6) AT 8:00 AM AND ADDITIONAL SEGREGATION AT THE END OF THE FEEDING TUBE WAS FOUND DURING THE REGULAR X-RAY EXAMINATION ON (B)(6) AT 6:30 AM. AFTER NOTIFYING THE MEDICAL DEPARTMENT, THE FEEDING TUBE WAS REMOVED TO CONFIRM THE ACTUAL SEPARATION. PER CUSTOMER, IT WILL BE REMOVED WITH AN ENDOSCOPE LATER. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE WEIGHTED TIP WAS DETACHED. PER CUSTOMER, THE HOSPITAL HAS DELIVERED THE CURRENT SITUATION TO THE PATIENT AND PATIENT CAREGIVERS WITHOUT PROCEEDING FURTHER MEDICAL INTERVENTION/PROCEDURE TO REMOVE THE END OF THE FEEDING TUBE. THROUGH X-RAY DIAGNOSIS, IT WAS CONFIRMED THAT ONE TUNGSTEN IS IN THE STOMACH AND THREE IN THE SMALL INTESTINE. THE PATIENT WAS FASTING UNTIL (B)(6) 2023 AND WILL EAT FROM (B)(6) 2023, SO THE HOSPITAL WILL SEE IF IT CAN BE REMOVED WITH FECES FOR NOW. THE CUSTOMER FURTHER STATED THAT THE PATIENT HAS BEEN MOVED FROM THE INTENSIVE CARE UNIT TO THE GENERAL WARD ON (B)(6) 2023, AND NO SERIOUS PROBLEMS HAVE BEEN REPORTED DUE TO THE FEEDING TUBE. FURTHER ADDITIONAL INFORMATION IS NOT AVAILABLE DUE TO PATIENT PRIVACY PROTECTION FROM THE HOSPITAL. A

  Patient problems: Foreign Body In Patient

  MAUDE report 16117705 ↗
• MalfunctionJan 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE NURSE FOUND THAT THE WEIGHTED TIP WAS SEPARATED DURING THE PRODUCT VERIFICATION PROCESS. THE PRODUCT WAS NOT USED ON PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16113658 ↗
• MalfunctionOct 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DOCTOR DID NOT REQUIRE ANY MEDICAL INTERVENTION, JUST A BAND AID.

  Patient problems: Needle Stick/Puncture

  MAUDE report 15543434 ↗
• MalfunctionOct 5, 2022Difficult to Remove; Detachment of Device or Device Component; Material Twisted/Bent; Difficult to Remove; Detachment of Device or Device Component; Material Twisted/Bent

  THE CUSTOMER REPORTED THEY INSERTED THE TUBE AND AN X-RAY CONFIRMED THAT IT WAS FIT FOR USE. WHEN INFUSING MEDICATION, THERE WAS RESISTANCE. THEY VERIFIED BENDING OF THE MATERIAL DURING ITS PASSAGE AND REMOVAL OF THE MANDREL (GUIDE WIRE). THE MANDREL HAD EXTREME RESISTANCE WHEN BEING REMOVED AND THE GREEN CONNECTOR DISCONNECTED FROM THE WIRE, HURTING HANDS AND CUTTING GLOVES.

  Patient problems: Laceration(s)

  MAUDE report 15542528 ↗
• MalfunctionSep 30, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE GUIDE WIRE GETS "STUCK" AND WILL NOT COME OUT UNLESS FORCE IS USED. IT WAS CONFIRMED THAT THEY INSERTED PER THE INSTRUCTIONS AND ALSO FLUSHED THE TUBE WITH WATER TO HELP IT SLIDE OUT AS RECOMMENDED. ALSO, THE CAP IS COMING OFF THE GUIDEWIRE AND POKING STAFF. ADDITIONAL INFORMATION RECEIVED STATED THE CUSTOMER KNOWS OF AT LEAST TWO TIMES THAT A STAFF MEMBER GOT STUCK FROM THE GUIDEWIRE. NO MEDICAL INTERVENTION WAS REQUIRED. SEVERAL STAFF MEMBERS HAVE REPORTED THE GUIDE WIRE GOT STUCK AND THE CAP CAME OFF BUT THEY DIDN'T REPORT IT AT THE TIME. THEY DON'T KNOW THE LOT NUMBER BECAUSE THESE WERE ALL IN THE PAST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15519545 ↗
• MalfunctionSep 9, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  CUSTOMER REPORTS: THE PROFESSIONAL WAS REMOVING THE METAL GUIDE FROM THE SNE THAT HAD ALREADY PASSED ON THE PATIENT WHEN THE PLASTIC TIP LOOSENED AND THE METAL PART (WHICH LOOKS LIKE A HOOK) ENTERING AND PIERCING THE FINGER. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022, THERE WAS A LOT OF RESISTANCE TO RELEASE THE GUIDEWIRE AND THE TIP RELEASED FROM THE GUIDE WIRE. CURATIVE INTERVENTION WAS REQUIRED AS A RESULT OF THE PUNCTURE TO THE NURSE.

  Patient problems: Laceration(s)

  MAUDE report 15396842 ↗
• MalfunctionSep 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED WHEN THEY WENT TO REMOVE THE METAL GUIDE OF THE SNE (NASO TUBE) THAT HAD ALREADY BEEN PLACED IN THE PATIENT, THE PLASTIC TIP CAME LOOSE AND THE METAL PART (WHICH LOOKS LIKE A HOOK) ENTERED THEIR FINGER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15369493 ↗
• MalfunctionSep 6, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  THE CUSTOMER REPORTED THAT IT WAS EXTREMELY DIFFICULT TO REMOVE THE CHUCK FROM THE PROBE. PER ADDITIONAL INFORMATION PROVIDED ON SEPTEMBER 01, 2022, IT WAS THE GUIDEWIRE THAT WAS EXTREMELY DIFFICULT TO REMOVE. NO INJURIES OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15363932 ↗
• MalfunctionSep 6, 2022Detachment of Device or Device Component; Difficult or Delayed Separation; Detachment of Device or Device Component; Difficult or Delayed Separation

  THE CUSTOMER REPORTED THAT THERE WAS EXTREME DIFFICULTY REMOVING THE CHUCK FROM THE PROBE. WHEN PULLING ON THE SUPPORT TO REMOVE THE CHUCK, IN ADDITION TO IT BEING VERY STRONG, THE PART LEFT AND THE WIRE FINISHED IN THEIR FINGER. PER ADDITIONAL INFORMATION PROVIDED ON SEPTEMBER 01, 2022, IT WAS THE GUIDEWIRE THAT WAS DIFFICULT TO REMOVE FROM THE TUBE AND THE GUIDEWIRE COVER CAME OFF. THE GUIDEWIRE SNAKED THEIR FINGER. A DRESSING WAS USED TO STOP THE BLEEDING.

  Patient problems: Laceration(s)

  MAUDE report 15363507 ↗
• MalfunctionAug 9, 2022Use of Device Problem; Use of Device Problem

  CUSTOMER REPORTS: THERE WAS A PROBLEM WITH THE GREEN DEVICE ON THE PROBE BECAUSE IT DID NOT AFFIX WELL TO THE GUIDE WIRE. WHEN IT WAS RELEASED IT PERFORATED THE NURSE TECHNICIAN.

  Patient problems: Needle Stick/Puncture

  MAUDE report 15195701 ↗
• MalfunctionFeb 9, 2022Fluid/Blood Leak; Difficult to Remove; Material Integrity Problem; Fluid/Blood Leak; Difficult to Remove; Material Integrity Problem

  CUSTOMER REPORTS; THE PROBE WAS WARPED AND WHEN PASSED ONTO THE PATIENT IT FOLDS NOT ALLOWING THE PASSAGE OF DIET, MEDICATIONS, WATER, ETC. THE DEVICE OVERFLOWED (LEAKED) BUT THE TUBING IS NOT KINKED. THE STYLET GOT STUCK MAKING IT DIFFICULT TO REMOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13500563 ↗
• MalfunctionFeb 9, 2022Fluid/Blood Leak; Difficult to Remove; Material Integrity Problem; Fluid/Blood Leak; Difficult to Remove; Material Integrity Problem

  CUSTOMER REPORTS; THE PROBE WAS WARPED AND WHEN PASSED ONTO THE PATIENT IT FOLDS NOT ALLOWING THE PASSAGE OF DIET, MEDICATIONS, WATER, ETC. THE DEVICE OVERFLOWED (LEAKED) BUT THE TUBING IS NOT KINKED. THE STYLET GOT STUCK MAKING IT DIFFICULT TO REMOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13500374 ↗
• MalfunctionJan 28, 2022Fluid/Blood Leak; Difficult to Remove; Material Integrity Problem; Fluid/Blood Leak; Difficult to Remove; Material Integrity Problem

  CUSTOMER REPORTS; THE DEVICE MEMORY IS WARPED, THE CLAMP WAS NOT CLOSING AND THERE WAS AN OVERFLOW. IT WAS DIFFICULT TO REMOVE THE GUIDE WIRE AS IT WAS SHORT AND DID NOT REACH THE END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13386867 ↗
• MalfunctionDec 28, 2021Material Twisted/Bent; Material Twisted/Bent

  THE CUSTOMER REPORTED THE TUBE WAS BENDING AT THE TIME OF PASSAGE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13101145 ↗
• MalfunctionOct 13, 2021Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE FEEDING TUBE WAS INSERTED TO THE PATIENT AND NOTED DIFFICULTY PULLING OUT THE GUIDEWIRE OUT. THE END OF THE GUIDEWIRE WITH THE GREEN CAP CAME APART AND POKED WRITER¿S LEFT THUMB. THE FEEDING TUBE WAS FLUSHED WITH STERILE WATER AND ABLE TO PULL OUT THE GUIDEWIRE. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS NO MEDICAL INTERVENTION OR TREATMENT REQUIRED TO THE STAFF INVOLVED AND THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 12623525 ↗
• MalfunctionOct 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE STYLET TIP COMES OFF OF THE STYLET AS IT IS BEING REMOVED FROM THE DOBBHOFF TUBE. THIS HAS OCCURRED SEVERAL TIMES IN MORE THAN ONE UNIT OF THE HOSPITAL AND A COUPLE NURSES WERE PUNCTURED. THE PROBLEM DOES NOT HAPPEN WITH EVERY FEEDING TUBE. INDIVIDUAL INCIDENT INFORMATION IS NOT AVAILABLE AND NO ADDITIONAL INFORMATION IS KNOWN.

  Patient problems: Needle Stick/Puncture

  MAUDE report 12584461 ↗