Kangaroo 8884720247 (UDI 10884521007352)Recalls & reported problems
Cardinal Health, Inc. · Gastrostomy Feeding Tube with Y-Ports,20 mL · Class 2 · Implant
Quick summary
This Cardinal Health Kangaroo gastrostomy feeding tube is used to deliver nutrition through the stomach. Most of the 30 reports describe the balloon or cuff losing air, rupturing, or developing holes, sometimes discovered during surgery even in sealed packaging, and tubes leaking fluid. One injury was reported and no deaths. There are no recalls naming this device, and no reports in the past 12 months compared with 3 in the prior 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10884521007352), received between Jan 11, 2021 and Jul 7, 2025 — classified as 1 injury, 29 malfunctions.
The most frequently reported specific device problem is “Unintended Deflation” (12 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.
Reports received per month
Most reported problems
Device problems
- Unintended Deflation12
- Fluid/Blood Leak7
- Material Rupture6
- Material Puncture/Hole2
- Break1
- Deflation Problem1
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- Abdominal Distention1
- Abdominal Pain1
- Localized Skin Lesion1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 7, 2025Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT DURING THE PROCEDURE, THE SURGEON IDENTIFIED A HOLE IN THE GASTROSTOMY TUBE BALLOON. THE MATERIAL WAS STORED IN PRIMARY PACKAGING SEALED BY THE MANUFACTURER BEFORE THE EVENT WAS IDENTIFIED. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22423543 ↗MalfunctionFeb 21, 2025Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THE PROBE WAS LEAKING, THE BALLOON RUPTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21437251 ↗MalfunctionDec 30, 2024Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT DURING THE PROCEDURE, THE SURGEON IDENTIFIED A HOLE IN THE BALLOON OF THE GASTROSTOMY TUBE. PER CUSTOMER, THE MATERIAL WAS STORED IN PRIMARY PACKAGING SEALED BY THE MANUFACTURER BEFORE THE EVENT WAS IDENTIFIED. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21034615 ↗MalfunctionJul 9, 2024Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT AFTER 5 DAYS OF USING THE PROBE, IT BURST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19705657 ↗MalfunctionMar 6, 2024Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT A PATIENT USING A GASTRIC TUBE THAT WAS INSERTED ON (B)(6) 2023 WAS EXTERNALIZED DUE TO RUPTURE OF THE FIXATION CUFF ON (B)(6) 2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18849801 ↗MalfunctionJul 12, 2023Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THE PATIENT EXCHANGED THE DEVICE ON (B)(6), 2023 AND OBSERVED THAT THE BALLOON WAS PUNCTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17305717 ↗MalfunctionJun 30, 2023Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT A PATIENT WITH A KANGAROO GASTROSTOMY TUBE WHICH, WHEN VERIFYING ITS INTEGRITY, DISPLACEMENT WAS FOUND. THE DEVICE WAS REVIEWED TOGETHER WITH THE DOCTOR ON DUTY AND AN AIR LEAK WAS FOUND IN THE SAFETY BALLOON. THE GASTROSTOMY TUBE WAS REPLACED AND THE GASTROENTEROLOGIST ON DUTY WAS INFORMED, WHO SUGGESTS CHANGING IT TO A NEW NUMBER 24 REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17238688 ↗MalfunctionApr 3, 2023Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT ONE OF THEIR CLIENTS USING A 24 FR KANGAROO PROBE REPORTED THAT IT (THE BALLOON) IS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16663096 ↗MalfunctionMar 20, 2023Material Rupture; Material Rupture
CUSTOMER REPORTS: ON 03/02/2023, THE DOCTOR PERFORMED AN EXCHANGE, PLACING THE KANGAROO BRAND PROBE. ON (B)(6) 2023, IT WAS OBSERVED THAT A REPLACEMENT WAS REQUIRED AS THE BALLOON HAD RUPTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16575779 ↗MalfunctionMar 20, 2023Material Rupture; Material Rupture
CUSTOMER REPORTS: ON (B)(6) 2023, THE DOCTOR PERFORMED AN EXCHANGE, PLACING THE KANGAROO BRAND PROBE FOR THE FIRST TIME. ON 03/02/2023, IT WAS OBSERVED THAT A REPLACEMENT WAS REQUIRED AS THE BALLOON HAD RUPTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16575454 ↗MalfunctionJan 18, 2023Deflation Problem; Deflation Problem
THE CUSTOMER REPORTED THAT WHEN OPENING THE PACKAGE AND CARRYING OUT THE TEST WITH INFLATION OF THE CUFF, IT WAS PIERCED, MAKING IT IMPOSSIBLE TO USE THE PROBE. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16194918 ↗MalfunctionOct 27, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE PATIENT'S RELATIVE REPORTS THAT ONE OF THE LUMEN LIDS DOES NOT CLOSE PROPERLY AND THAT IS WHY THE FOOD SPILLS OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15679876 ↗MalfunctionOct 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE PROBE WAS LEAKING. NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15638427 ↗MalfunctionOct 6, 2022Material Rupture; Material Rupture
CUSTOMER REPORTS: AFTER ONE MONTHS USE, THERE WAS RUPTURE OF THE 24FR COVIDIEN PROBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15552212 ↗MalfunctionOct 5, 2022Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT THEY PURCHASED THE DEVICE ON (B)(6) 2022 AND ON (B)(6) 2022, THE INSERTION PROCEDURE WAS CARRIED OUT. ON (B)(6) 2022, THE PROBE CAME OUT AND THE HOSPITAL PLACED A PROVISIONAL ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15544589 ↗MalfunctionOct 5, 2022Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT THEY PURCHASED THE DEVICE ON (B)(6) 2022 AND ON (B)(6) 2022, THE INSERTION PROCEDURE WAS CARRIED OUT. ON (B)(6) 2022, THE PROBE CAME OUT AND THE PATIENT HAD BEEN TAKEN BACK TO THE HOSPITAL FOR THE EXCHANGE. THE DOCTOR STATED THAT ALL THE LIQUID FROM THE PROBE BALLOON LEAKED. THE PROBE WAS REPLACED AGAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15544576 ↗MalfunctionOct 1, 2022Material Rupture; Material Rupture
THE CUSTOMER REPORTED THAT THE BALLOON WAS BROKEN. NO INJURY REPORTED. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15523003 ↗MalfunctionSep 23, 2022Material Rupture; Material Rupture
THE CUSTOMER REPORTED THAT WHEN MAKING THE CHANGE OF THE ENTERAL NUTRITION TEAM, A RUPTURE IN THE FEEDING ROUTE AND LEAKING OF NUTRITION WAS OBSERVED. THE DEVICE WAS REPLACED WITH ANOTHER DEVICE WITH THE SAME CHARACTERISTICS. THERE WAS NO MEDICAL INTERVENTION REQUIRED AND NO INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15471870 ↗MalfunctionJul 15, 2022Obstruction of Flow; Obstruction of Flow
THE CUSTOMER REPORTED THAT THE ITEM IS OBSTRUCTED AND ANOTHER PROBE WAS PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15031951 ↗MalfunctionJun 21, 2022Material Puncture/Hole; Material Puncture/Hole
THE CUSTOMER REPORTED THAT THE BALLOON WAS PUNCTURED. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14759418 ↗MalfunctionJun 21, 2022Material Puncture/Hole; Material Puncture/Hole
THE CUSTOMER REPORTED THAT THE BALLOON WAS PUNCTURED. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14756321 ↗MalfunctionMay 7, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FISSURE IN THE COVER OF THE GASTROSTOMY TUBE WITH PORT "Y", THROUGH WHICH THE FOOD FILTERS WHEN IT RISES. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE PURPLE Y-PORT WAS CRACKED ALONG WITH USE, BECAUSE AT THE BEGINNING THE PORT WAS INTACT. PER CUSTOMER, THE MEAL SOLUTION WAS LEAKING THROUGH THE CRACK. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14316345 ↗MalfunctionMay 7, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE PURPLE Y-PORT WAS CRACKED ALONG WITH USE, BECAUSE AT THE BEGINNING THE PORT WAS INTACT. PER CUSTOMER, THE MEAL SOLUTION WAS LEAKING THROUGH THE CRACK. THERE WAS NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14316053 ↗MalfunctionApr 19, 2022Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT THE BALLOON IS DEFLATING FREQUENTLY. THE BALLOON IS ASYMMETRICAL AND IT DEFLATED WITHIN 6 DAYS. THE BALLOON WAS INFLATED WITH 20 ML STERILE AND 20 ML STERILE WATER AS PER THE RECOMMENDATION OF THE MANUFACTURER. THE EXPERIMENT WAS STARTED ON (B)(6) AFTER CONSULTING A GASTROENTEROLOGIST. ON (B)(6), THE KANGAROO TUBE DEFLATED BY 0,4 CM AND CONTINUED DEFLATING ON (B)(6) BY A TOTAL OF 1.2 CM. USUALLY, GASTROSTOMY TUBES SHOULD STAY TILL AROUND 3-6 MONTHS. PER ADDITIONAL INFORMATION RECEIVED ON 15-APR-2022, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. THE EXPERIMENT WAS DONE IN VITRO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14141233 ↗MalfunctionApr 19, 2022Material Rupture; Material Rupture
THE CUSTOMER REPORTED THAT THEY HAVE HAD INCIDENTS OF BREACH IN PATIENT SAFETY IN LESS THAN 2 WEEKS BECAUSE OF A BALLOON DETACHMENT USING THIS PRODUCT. THEY DIDN'T HAVE ANY PROBLEM WITH THE OLD BRAND OF THE KANGAROO PRODUCTS BUT ACCORDING TO THEIR EVALUATION OF THIS NEW ONE, IT HAD A DEFECT SINCE THEY TRIED INFLATING THE BALLOON TO MONITOR IT FOR 24 HOURS AND AFTER 3 HOURS, THEY FOUND THAT THE BALLOON DEFLATED BY 50%. THE NURSES COMPLAINED THAT THE Y-PORT (UPPER PART WHERE THE FEEDING TUBE IS ATTACHED) WAS GETTING LOOSE AFTER USING IT FOR SOME TIME. PER ADDITIONAL INFORMATION RECEIVED ON 03APR2022, THE CUSTOMER STATED THAT THE BALLOON BURST. PER ADDITIONAL INFORMATION RECEIVED ON 15APR2022, AN INDWELLING CATHETER WAS INSERTED AS A REPLACEMENT IN SOME OF THE PATIENTS. IN TWO OF THE PATIENTS, THE STOMA WAS STILL IMMATURE DUE THE DISLODGEMENT OF THE DEVICE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14141225 ↗
Other TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices
- Bard® DigniShield® Stool Management System SMS002C. R. Bard, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 deaths525 reports
- CORTRAK* 2 ENTERAL ACCESS SYSTEM 20-0950Avanos Medical, Inc. · Tubes, gastrointestinal (and accessories)1 recall22 deaths134 reports
- Bard Tri-Funnel Replacement Gastrostomy Tube 000720Bard Access Systems, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 death170 reports
- EndoVive Safety PEG Kit M00566470Boston Scientific Corporation · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall1 death111 reports
- Kangaroo 8884711253Cardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)152 reports
- Kangaroo 8884711253ECardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)100 reports
- NutraGlide Nasal Feeding Tube ENFT-05055-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-06090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.