Kangaroo 8884715122Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521007154), received between Jul 29, 2019 and Dec 30, 2024 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2024Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT A GASTROSTOMY TUBE WAS PLACED AT THE NATIONAL PEDIATRICS INSTITUTE THROUGH PRONAMAC ON (B)(6) 2024. HOWEVER, SIX HOURS AFTER PLACEMENT THE DEVICE CAME OUT SPONTANEOUSLY WHILE THE PATIENT WAS CRYING AND IRRITABLE. THE BALLOON WAS REPOSITIONED TO 3CC OF WATER. AFTER RELOCATION OF THE TUBE ON (B)(6) 2024 IT WAS DECIDED TO REPLACE THE GASTROSTOMY TUBE ON (B)(6) 2024, HOWEVER LEAKAGE WAS IDENTIFIED DURING SAID REPLACEMENT. A NEW 14 FR TUBE WAS PLACED AND FIXED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21044602 ↗
• MalfunctionApr 28, 2023Material Perforation; Material Perforation

  THE CUSTOMER REPORTED THAT ON (B)(6) 2023 THE PATIENT HAD THE GASTROSTOMY BALLOON CHECKED PER PROTOCOL AND THE BALLOON WAS FOUND WITHOUT WATER. IT WAS REVIEWED IN THE CLINICAL HISTORY THAT THE TUBE WAS PLACED ON (B)(6) WHERE THEY DESCRIBED THAT THEY INSUFFLATED WITH 5 MILLILITERS OF DISTILLED WATER AND IT WAS REPORTED TO THE INTENSIVIST ON DUTY AND INSUFFLATED AGAIN WITH 5 MILLILITERS OF WATER. ON (B)(6) AT THE BEGINNING OF THE SHIFT, THE SURGEON ENTERS AND THE SITUATION WAS DISCUSSED. SHE REPORTED THAT BECAUSE IT WAS SO RECENT, IT WAS BETTER NOT TO CHECK THE BALLOON AGAIN, BUT SHE DID ORDER AN ULTRASOUND OF THE ABDOMEN. IN THE AFTERNOON, THE ROOM WAS ENTERED AND THE GASTROSTOMY BALLOON WAS FOUND ON THE OUTSIDE. THE BALLOON WAS VERIFIED AND IT WAS PERFORATED. THE INTENSIVIST AND SURGEON ON DUTY WHO SCHEDULES FOR URGENT SURGERY WERE INFORMED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16832029 ↗
• MalfunctionNov 8, 2022Material Rupture; Material Rupture

  THE CUSTOMER REPORTED THAT A 2-MONTH-OLD PATIENT WAS TRANSFERRED TO THE SURGERY ROOM ON THE DAY TO PERFORM A TRACHEOSTOMY AND GASTROSTOMY, DURING THE PLACEMENT OF THE #12 FR GASTROSTOMY TUBE, THE BALLOON WAS BROKEN. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT. PER CUSTOMER, THE PATIENT IS IN GOOD HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15753009 ↗
• MalfunctionOct 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED A FAMILY MEMBER OF A MALE PATIENT UNDER 1 YEAR OF AGE WHO IS HOSPITALIZED BY THE INFANTS SERVICE WITH A MEDICAL DIAGNOSIS OF MIXED CHRONIC MALNUTRITION, NEUROGENIC DYSPHAGIA AND DILATATED HEART DISEASE WHO USES A 12FR GASTROSTOMY TUBE CALLED STATING THAT THE TUBE HAS A LEAK. THE CUSTOMER FURTHER STATED THAT IT WAS VERIFIED; BREAKAGE OF THE UNION OF THE KEY IS EVIDENCED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15542532 ↗
• InjuryJan 20, 2022Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT ON (B)(6) 2021 A (B)(6) OLD PATIENT ON POSTOPERATIVE DAY TWO OF LAPAROSCOPIC GASTROSTOMY WAS USING KANGAROO GASTROSTOMY TUBE WITH BALLOON # 12. THE PATIENT STARTED ENTERAL NUTRITION AND THE ASSISTANT WAS MONITORING EVIDENCE OF THE FULL SHEET OF GASTRIC CONTENT. THE CHIEF IN CHARGE OF NUTRITIONAL SUPPORT WAS NOTIFIED AND SHE VERIFIED AND TESTED BY POURING WATER WITH A SYRINGE INTO THE TUBE, CAPPING IT AND THEN TURNING IT OVER AND THERE WAS WATER LEAKAGE. IT WAS ALSO EVIDENCED ON (B)(6) 2021 THAT THERE WAS DISPLACEMENT OF THE PROBE, WHICH MOVED TO THE ABDOMINAL WALL. IN THE MORNING, THE HEAD IN CHARGE OF THE PATIENT EVIDENCED THE PROBE OUTSIDE. THE BALLOON WAS LEFT OUTSIDE AND LOST WATER BECAUSE THE SURGEON FILLED IT WITH 3CC OF WATER AND HE WOKE UP WITH 2CC, LOSING 1CC OF WATER IN JUST FOUR DAYS. THE PATIENT WAS TRANSFERRED BACK TO SURGERY TO PROPERLY REPOSITION THE CATHETER. PER ADDITIONAL INFORMATION RECEIVED ON 01/14/2022, THE CUSTOMER STATED THERE WAS LEAKING FROM THE Y PORT. IN ADDITION TO THE LEAKING Y PORT, THE BALLOON DEFLATED CAUSING THE TUBE TO BE DISPLACED FROM THE PATIENT AND THEN A NEW TUBE WAS REPLACED. PER THE CUSTOMER, THE BALLOON VOLUME WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13308087 ↗
• MalfunctionDec 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE DIET WAS LEAKING INTO THE FEEDING TUBE'S CAP WHEN ADMINISTERING THE DIET. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12960525 ↗
• MalfunctionJul 30, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THE GASTROSTOMY FEEDING TUBE WAS LEAKING AND DIFFICULT TO FLUSH AND CLEAN. THE TUBE WAS REPLACED AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8841077 ↗
• MalfunctionJul 29, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTS THAT THE GASTRONOMY FEEDING TUBE WAS LEAKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8837262 ↗
• MalfunctionJul 29, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTS THAT THE GASTRONOMY FEEDING TUBE WAS LEAKING. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8836524 ↗
• MalfunctionJul 29, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTS THAT THE GASTRONOMY FEEDING TUBE WAS LEAKING. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8836309 ↗