Kangaroo 8884720205 (UDI 10884521007291)Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10884521007291), received between Jul 25, 2019 and Jun 19, 2025 — classified as 36 malfunctions.

The most frequently reported specific device problem is “Unintended Deflation” (17 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2025Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT THE BROKEN BLADDER CAUSED INTERNALLY LEAKAGE. PER CUSTOMER, EVERYTHING WORKS NORMALLY UNTIL THE "BLADDER" BREAKS, FORCING THEM TO GET THE NURSE BACK TO CHANGE THE TUBE. THE PATIENT HAS A NURSE WHO PLACES THEM AND CHANGES THEM, AND SHE IS SPECIALIZED IN TUBE FEED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT "BLADDER BREAKS" REFERS TO BALLOON SPLITS/BREAKS. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292921 ↗
• MalfunctionJun 12, 2025Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT THE BALLOON LASTED 19 DAYS AND LOST ITS VOLUME AND FILLED WITH SOME MEDICATION THAT HAD JUST BEEN ADMINISTERED. THE MEDICATION WAS YELLOW, AND THE CONTENTS OF THE BALLOON WAS ALSO YELLOW. PER CUSTOMER, NO FOOD HAD BEEN ADMINISTERED PRIOR TO THIS. THE DEVICE WAS INSERTED ON (B)(6) 2025 BY A NURSE WHO SPECIALIZES IN TUBE FEED AND FAILED ON (B)(6) 2025. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22198895 ↗
• MalfunctionJun 12, 2025Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT THE BROKEN BLADDER CAUSED INTERNALLY LEAKAGE. PER CUSTOMER, EVERYTHING WORKS NORMALLY UNTIL THE "BLADDER" BREAKS, FORCING THEM TO GET THE NURSE BACK TO CHANGE THE TUBE. THE PATIENT HAS A NURSE WHO PLACES THEM AND CHANGES THEM, AND SHE IS SPECIALIZED IN TUBE FEED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT "BLADDER BREAKS" REFERS TO BALLOON SPLITS/BREAKS. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22196392 ↗
• MalfunctionJun 12, 2025Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT THE BROKEN BLADDER CAUSED INTERNALLY LEAKAGE. PER CUSTOMER, EVERYTHING WORKS NORMALLY UNTIL THE "BLADDER" BREAKS, FORCING THEM TO GET THE NURSE BACK TO CHANGE THE TUBE. THE PATIENT HAS A NURSE WHO PLACES THEM AND CHANGES THEM, AND SHE IS SPECIALIZED IN TUBE FEED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT "BLADDER BREAKS" REFERS TO BALLOON SPLITS/BREAKS. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22196349 ↗
• MalfunctionJun 12, 2025Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT THE BROKEN BLADDER CAUSED INTERNALLY LEAKAGE. PER CUSTOMER, EVERYTHING WORKS NORMALLY UNTIL THE "BLADDER" BREAKS, FORCING THEM TO GET THE NURSE BACK TO CHANGE THE TUBE. THE PATIENT HAS A NURSE WHO PLACES THEM AND CHANGES THEM, AND SHE IS SPECIALIZED IN TUBE FEED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT "BLADDER BREAKS" REFERS TO BALLOON SPLITS/BREAKS. PER CUSTOMER, THE ONE THE PATIENT IS CURRENTLY USING IS FINE SO FAR BUT HAS ONLY BEEN IN PLACE FOR 16 DAYS. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22196320 ↗
• MalfunctionNov 12, 2024Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED A PUNCTURED/BURST CUFF (BALLOON).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20663293 ↗
• MalfunctionNov 4, 2024Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THE CUFF BURST/RUPTURED 4 DAYS AFTER INSTALLING THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20598912 ↗
• MalfunctionOct 3, 2024Unintended Deflation; Unintended Deflation

  CUSTOMER REPORTS: THE DEVICE DEVELOPED LEAKS AND WAS EXTERNALIZED ON THE PATIENT. THE NURSE REPORTED THAT THE INSTALLATION OF THE DEVICE FOLLOWED ALL RECOMMENDATIONS FOR USE. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2024, THE LEAK OCCURRED AT THE INFLATION BALLOON AND WAS REPLACED. THE PATIENT DID NOT REQUIRED MEDICAL INTERVENTION AND THE DEVICE WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20359113 ↗
• MalfunctionSep 25, 2024Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT BALLOON LEAKED AND DEVICE EXTERNALIZED. PER CUSTOMER, THE NURSE STATED THAT THE INSTALLATION OF THE DEVICE FOLLOWED ALL RECOMMENDATIONS FOR USE. THE BALLOON WAS INFLATED WITH 15ML OF DISTILLED WATER. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305866 ↗
• MalfunctionJun 3, 2024Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT WITHIN 6HRS, THE BULB DEFLATED ON ITS OWN. THEY JUST INSERTED ONE AS WELL WITH NO ISSUES TO DATE FROM THE SAME ORDER. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT DEVELOPED PERITONITIS TO THE ABDOMEN AFTER THE GASTRIC ACIDS AND STOMACH CONTENTS ENDED UP IN THE ABDOMEN CAUSING AN INFECTION (FEVER AND REDNESS TO ABD). HIS LEVEL OF CONSCIOUSNESS DECREASED AND HE STOPPED EATING FOR A FEW DAYS. THIS EVENTUALLY IMPROVED AS HE WAS GIVEN A TRIAL PERIOD OF ANTIBIOTICS. THE STATUS OF THE PATIENT IS POST STROKE, ACP C (PRE THIS EVENT).

  Patient problems: Peritonitis

  MAUDE report 19454219 ↗
• MalfunctionJan 12, 2024Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED BALLOON RUPTURED AFTER THE THIRD DAY OF INSTALLATION IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509282 ↗
• MalfunctionJan 9, 2024Unintended Deflation; Unintended Deflation

  IT WAS REPORTED TO ANVISA ANONYMOUSLY THAT THE CUFF IS MUCH LARGER IN SIZE THAN OTHER TUBES. IN ONE SPECIFIC CASE WITH GENERAL ATROPHY, IT GENERATED VOMITING DUE TO HIGH VOLUME OF WATER FROM THE CUFF (20ML) WITH MIGRATION FROM THE CUFF TO THE DUODENUM. FREQUENT CUFF RUPTURE WITH PROBE IN LESS THAN 60 DAYS OF USE. DIFFICULT CONNECTION WITH DIET EQUIPMENT. FREQUENT SKIN REACTION WITH THE OSTIO. BAD SEAL ON THE PROBE COVERS. HOST LEAK. NO ADDITIONAL INFORMATION CAN BE REQUESTED AS THE INITIAL REPORTER IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation; Vomiting

  MAUDE report 18481033 ↗
• MalfunctionOct 19, 2023Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT DURING THE ENDOSCOPY PROCEDURE THEY NOTICED THAT THE RETENTION BALLOON WAS PUNCTURED. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON HAD A MALFUNCTION, THE BALLOON FOUND PIERCED AND LEAKED WATER. THE CUSTOMER FURTHER CLARIFIED THAT THE BALLOON WAS NOT PUNCTURED BY THE OPERATOR DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17970094 ↗
• MalfunctionAug 10, 2023Unintended Deflation; Unintended Deflation

  CUSTOMER REPORTS: THE PROBE DISPLACEMENT WAS DETECTED BY THE PUNCTURED BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17503105 ↗
• MalfunctionJan 30, 2023Break; Break

  THE CUSTOMER REPORTED THAT THE DEVICE WAS PUT IN ON (B)(6) 2022 AND ON (B)(6) 2022 IT WAS LOST DUE TO THE DEVICE HAVING A BREAKAGE IN THE BALLOON. NO OTHER INFORMATION IS ABLE TO BE OBTAINED AS THE EVENT WAS REPORTED ANONYMOUSLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16264338 ↗
• MalfunctionJan 3, 2023Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THEY HAD A PATIENT WITH AN OBSTRUCTED GASTROSTOMY TUBE. AT THE TIME OF WASHING, IT IS OBSERVED THAT ONE OF THE ADAPTERS IS LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16085900 ↗
• MalfunctionOct 3, 2022Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT AT THE TIME OF HOME CARE TRAINING FOR THE PATIENT WITH A GASTROSTOMY TUBE (PRACTICAL PART), A DEMONSTRATION WAS MADE OF HOW THE DEVICE IS WASHED AND WATER LEAKAGE WAS OBSERVED IN THE MIDDLE PART OF THE FEEDING AND MEDICATION LINES. WHEN TRYING TO DISCONNECT THE NUTRITION EQUIPMENT, IT WAS NOT POSSIBLE AND THE LINE WAS COMPLETELY BROKEN. 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 15528947 ↗
• MalfunctionSep 30, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT VIA A GASTROSTOMY, WHEN ATTEMPTING TO DISCONNECT, THE ENTERAL NUTRITION SET BREAKS THE DELIVERY LINE FROM THE TUBE ADAPTER. 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 15512188 ↗
• MalfunctionAug 31, 2022Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE PORT POPPING OUT OF GASTROSTOMY TUBE ITSELF. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE Y-PORT WAS POPPING OUT OF G -TUBE AND CAUSED MEDICATION AND FEED LOSS. THE G-TUBE WAS REPLACED. PER CUSTOMER, IT WAS UNKNOWN HOW MUCH MEDICATION AND FEED WERE LOST. THERE WAS NO PATIENT HARM AND NO MEDICATION INTERVENTION OR TREATMENT REQUIRED. THE PATIENT IS A 38-YEAR-OLD MALE, AND HE IS IN TOTAL CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15331186 ↗
• MalfunctionAug 31, 2022Material Rupture; Material Rupture

  THE CUSTOMER REPORTED A BROKEN BULLET. PER ADDITIONAL INFORMATION PROVIDED ON AUGUST 24, 2022, THE BALLOON DRILLED. THERE WERE NO FRAGMENTED PIECES. THE DEVICE WAS PLACED ON (B)(6) 2022. THERE WAS NO PATIENT INJURY. PER ADDITIONAL INFORMATION PROVIDED ON AUGUST 30, 2022, WHEN THEY CUSTOMER SAYS THE "BALLOON DRILLED", THEY MEAN THE BALLOON BURST. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15329187 ↗
• MalfunctionAug 31, 2022Material Rupture; Material Rupture

  THE CUSTOMER REPORTED A BROKEN BULLET. PER ADDITIONAL INFORMATION PROVIDED ON AUGUST 24, 2022, THE BALLOON DRILLED. THERE WERE NO FRAGMENTED PIECES. THE DEVICE WAS PLACED ON (B)(6) 2022. THERE WAS NO PATIENT INJURY. PER ADDITIONAL INFORMATION PROVIDED ON AUGUST 30, 2022, WHEN THEY CUSTOMER SAYS THE "BALLOON DRILLED", THEY MEAN THE BALLOON BURST. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15329145 ↗
• MalfunctionAug 31, 2022Material Rupture; Material Rupture

  THE CUSTOMER REPORTED A BROKEN BULLET. PER ADDITIONAL INFORMATION PROVIDED ON AUGUST 24, 2022, THE BALLOON DRILLED. THERE WERE NO FRAGMENTED PIECES. THE DEVICE WAS PLACED ON (B)(6) 2022. THERE WAS NO PATIENT INJURY. PER ADDITIONAL INFORMATION PROVIDED ON AUGUST 30, 2022, WHEN THE CUSTOMER SAYS THE "BALLOON DRILLED", THEY MEAN THE BALLOON BURST. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15329109 ↗
• MalfunctionAug 17, 2022Material Rupture; Material Rupture

  CUSTOMER REPORTS: NURSING CALLED TO REPORT THAT WHILE SLEEPING, THE GASTROSTOMY PROBE CAME OUT OF THE PATIENT. IT WAS INTRODUCED AGAIN BY GENERAL SURGERY TO CHANGE THE GASTROSTOMY PROBE. NO. 20FR AND LIDOCAINE IN JELLY ARE REQUESTED. THE BALLOON WAS FILLED WITH 15CC OF STERILE WATER. ADDITIONAL INFORMATION WAS PROVIDED ON 08/17/22 STATING THAT THE CATHETER WAS IN PLACE FOR 5 DAYS. THE BALLOON TORE WITH NO FRAGMENTED PIECES. THE PATIENT DID NOT RECEIVE FOOD FOR ONE NIGHT UNTIL THE PATIENT UNDERWENT SURGERY TO INSERT THE NEW TUBE AND REMAINS HOSPITALIZED, SINCE THE PATIENT WAS ALREADY HOSPITALIZED. THE COMPLETE CATHETER WAS CHANGED, NOT JUST THE BALLOON, AND HAS REMAINED IN THE PATIENT UNTIL HE IS DISCHARGED BY PHD AND SO FAR NO FAILURE HAS BEEN REPORTED BY THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15243632 ↗
• MalfunctionAug 15, 2022Material Rupture; Material Rupture

  CUSTOMER REPORTS: THE PATIENT GASTROSTOMY PROBE CAME OUT. THE BALLOON WAS INFLATED WITH 20CC OF SALINE SOLUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15229385 ↗
• MalfunctionAug 15, 2022Material Rupture; Material Rupture

  CUSTOMER REPORTS: NURSING CALLED TO REPORT THAT THE GASTROSTOMY PROBE CAME OUT AND IT IS EVIDENT THAT THE BALLOON BURST. THE BALLOON WAS INFLATED WITH 15 CC OF STERILE WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15229256 ↗