Kangaroo 724150Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521011397), received between Jul 1, 2020 and Apr 24, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2023Material Rupture; Material Rupture

  ADDITIONAL INFORMATION RECEIVED ON 04/27/23 STATES THAT THE BALLOON WAS INFLATED WITH 6ML OF STERILE WATER. THE BALLOON BURST WHILST IN SITU THEREFORE THE FRAGMENTS WILL HAVE BEEN PASSED BY PATIENT. THERE WAS NO FURTHER MEDICAL INTERVENTION.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16798449 ↗
• MalfunctionJul 1, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THERE WAS A SPONTANEOUS BURST OF THE BUTTON CUFF. THE PATIENT WAS IN DECUBITUS DORSAL, INFUSING ARTISANAL DIET AS USUAL AND PARENT NOTICED INTENSE LEAKAGE, WHEN HE LOOKED AT THE BUTTON THE SAME, IT WAS ALREADY SLIGHTLY EXTERNALIZED, THE NURSING TECHNICIAN ON DUTY ALSO SAW IT AND WHEN THEY PICKED UP THE BUTTON THEY SAW IT WAS LEAVING DUE TO SPONTANEOUS RUPTURE OF THE CUFF. ADDITIONAL INFORMATION WAS PROVIDED STATING THAT THE SALINE SOLUTION HAD ALREADY LEAKED, AS THE BALLOON BURST. THEN THE PROBE WAS LOOSE, LOOSE ALLOWING THE LEAK OF THE DIET THROUGH THE OSTOMY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10217791 ↗