Kangaroo 714120Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521010635), received between Feb 17, 2021 and Apr 19, 2023 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2023Break; Break

  THE CUSTOMER REPORTED THAT THE CHILD WAS HOSPITALIZED AT THE (B)(6) HOSPITAL IN (B)(6) AND THEREFORE LOWERED DURING THE DAYS AFTER THE PROCEDURE AND ON THE SEVENTH DAY AFTER THE SURGERY DURING THE PROBE PLACEMENT, WHICH WAS PERFORMED WITH 4 ML OF ABD, THE BALLOON BREAK INSIDE THE CHILD¿S ORGANISM, SO THE FAMILY IMMEDIATELY COMMUNICATED THE CUSTOMER. SEVERAL ATTEMPTS TO GATHER INFORMATION FROM THE CUSTOMER WERE MADE. TO DATE, NO RESPONSE HAS BEEN RECEIVED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, THE REPORT WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 16773350 ↗
• MalfunctionNov 21, 2022Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT THE DEVICE HAD TO BE REPLACED DUE TO A BALLOON LEAK (POSSIBLY RUPTURE ).THE PATIENT IS FINE. PER ADDITIONAL INFORMATION RECEIVED ON, THE PROBE MOVES EASILY AND THE BALLOON HAS LOST ITS SEAL. THE PROBE WAS REPLACED FOR THIS REASON. IT IS DIFFICULT TO JUDGE IF IT WAS A LEAK OR RUPTURE THAT CAUSED THIS WITHOUT A THOROUGH EXAMINATION. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15834327 ↗
• MalfunctionFeb 28, 2022Fluid/Blood Leak; Unintended Deflation; Fluid/Blood Leak; Unintended Deflation

  AS REPORTED BY THE CUSTOMER: THE DEVICE HAD TO BE REPLACED DUE TO A LEAK IN THE BALLOON WHICH WAS POSSIBLY DUE TO A RUPTURE. ADDITIONAL INFORMATION PROVIDED ON 2/25/22 STATED THAT AFTER 15 DAYS OF USE, A LEAK WAS FOUND INSIDE THE PATIENT AND THE DEVICE WAS REMOVED AND REPLACED WITH A NEW DEVICE. THE PATIENT EXPERIENCED NO COMPLICATIONS AND IS IN GOOD CONDITION. ON 2/28/22 FURTHER INFORMATION WAS PROVIDED STATING THAT THE CLIENT USES STERILE WATER TO INFLATE THE CUFF, AS SOON AS THE BALLOON CEASED TO BE TIGHT, THE CUSTOMER NOTICED THAT THE TUBE COULD SLIP OUT AND THE ADMINISTERED NUTRITIONAL FORMULA WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13619558 ↗
• MalfunctionFeb 3, 2022Material Puncture/Hole; Material Puncture/Hole

  THE CUSTOMER REPORTED A HOLE IN THE BALLOON. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446348 ↗
• MalfunctionFeb 3, 2022Material Rupture; Material Rupture

  THE CUSTOMER REPORTED A BURST BALLOON. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446203 ↗
• MalfunctionDec 13, 2021Fracture; Fracture

  THE CUSTOMER REPORTED THAT THE DEVICE SPLIT WHERE THE SHAFT MEETS THE TOP OF THE BUTTON CAUSING LARGE LEAKAGE AND IRRITATION. THE DEVICE WAS PLACED ON (B)(6) 2021 AND REMOVED ON (B)(6) 2021, IT HAD STARTED LEAKING THE WEEK PRIOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12988420 ↗
• MalfunctionDec 13, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THEY WERE HAVING ISSUES WITH EXCESSIVE LEAKAGE AND WHEN THEY REMOVED THE DEVICE, THEY FOUND IT TO HAVE A VERY LOPSIDED BALLOON. THEY TRIED TO MASSAGE THE BALLOON TO SEE IF IT WOULD GO TO A NORMAL SHAPE BUT IT DOES NOT SEEM TO. THE DEVICE WAS INSERTED ON (B)(6) 2021 AND REMOVED ON (B)(6) 2021. ADDITIONAL INFORMATION RECEIVED ON 24-NOV-2021 STATED THAT THE LEAKAGE WAS AT THE STOMA SITE (AROUND THE SKIN LEVEL DEVICE). LEAKAGE WAS A COMBINATION OF FORMULA, GASTRIC CONTENTS ETC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12984675 ↗
• InjuryFeb 17, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE PATIENT WAS UNDER MANAGEMENT IN CONJUNCTION WITH THE WOUND CLINIC, FROM (B)(6) 2020, DUE TO PERISTOMAL LEAK AND SECONDARY BURN. THE PATIENT IS A 2-YEAR-OLD MALE. PER CUSTOMER, FIRST THEY CLEANED THE PERISTOMAL TISSUE, THE GASTROSTOMY BALLOON WAS REMOVED, 2% LIDOCAINE WAS APPLIED AND A 12 FR FOLEY CATHETER WAS INSERTED. THE BALLOON WAS INFLATED WITH 5CC OF WATER, THE BALLOON REMAINING IN THE GASTRIC CHAMBER, AFTER THE PERISTOMAL SKIN WAS DRIED AND PROTECTIVE POWDER WAS APPLIED, AN OCCLUSIVE THERAPY WAS PERFORMED, AND IT WAS REINFORCED TO FACILITATE CLOSURE IN PERISTOMAL DILATION. THE PRODUCT WAS WORKING WELL, BUT WHEN THEY RE-INSERT THE BALLOON, THEY IDENTIFIED RUPTURE IN THE UPPER PART OF THE BALLOON. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THAT IT WAS NOT SURE IF THE PRODUCT WAS CONTRIBUTED TO THE PERISTOMAL LESION. THE CUSTOMER ALSO CONFIRMED THAT A NUTRITION LEAK WAS OBSERVED. THE CUSTOMER FURTHER STATED THAT THE PATIENT HAD PERISTOMAL LESION SECONDARY TO A LEAKAGE. THE PATIENT REQUIRED SEVERAL DRESSINGS DUE TO CLINICAL WOUNDS AND OSTOMIES. THE BALLOON WAS USED FROM (B)(6) 2020. THE PATIENT WAS DISCHARGED ON (B)(6) 2020 DUE TO FAVO

  Patient problems: Burn(s); Tissue Breakdown

  MAUDE report 11340534 ↗