Kangaroo 718150Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521011120), received between Jan 26, 2021 and Oct 18, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2023Break; Break

  CUSTOMER REPORTS: THE G TUBE LEAKED ON TWO UNITS FROM THE SAME BATCH. PER ADDITIONAL INFORMATION RECEIVED ON 10/11/23 , THE LEAK OCCURRED AT THE TUBE CONNECTION. BOTH INCIDENTS OCCURRED WITH THE SAME PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17961575 ↗
• MalfunctionMay 5, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  CUSTOMER REPORTS: THE TUBE WAS INITIALLY PLACED (B)(6) 2023 AND SPLIT IN THE PATIENT. THE DEVICE HAS BEEN REPLACED WITH THE SAME PRODUCT ON THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16880867 ↗
• MalfunctionApr 24, 2023Material Rupture; Material Rupture

  ADDITIONAL INFORMATION RECEIVED ON 04/26/23 STATES THAT THE BALLOON WAS INFLATED WITH 6ML OF STERILE WATER. THE BALLOON BURST WHILST INSIDE THE PATIENT¿S GUT. IT IS ASSUMED THAT THE FRAGMENTS WERE PASSED BY PATIENT. THERE WAS NO FURTHER MEDICAL INTERVENTION.

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

  MAUDE report 16797311 ↗
• MalfunctionMar 2, 2023Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT IN RECENT DAYS THEY BOUGHT A GASTROSTOMY BUTTON AND AFTER APPLYING IT TO THE PATIENT, IT CAME OUT TWO DAYS LATER. IT IS EVIDENT THAT THERE IS WATER LEAKING OUT OF THE BALLOON AT THE TIP, APPARENTLY DUE TO THE ASSEMBLY OF THE TUBE AND THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16471138 ↗
• MalfunctionJan 26, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT ALL FEEDS POURING OUT AROUND STOMA. THE NUTRIPORT WAS PLACED ON (B)(6) 2020. WHEN CHECKED THE TUBE UNDER THE TOP SECTION WHERE THE SHAFT JOINS, THERE IS A SPLIT IN IT. A NEW NUTRIPORT OF SAME SIZE HAS BEEN REPLACED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11230180 ↗