Kangaroo 720200Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521011274), received between Jun 8, 2022 and May 23, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Unintended Deflation” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2024Unintended Deflation; Unintended Deflation

  CUSTOMER REPORTS: THERE IS A PROBLEM WITH THE BALLOON AS IT DOES NOT REMAIN INFLATED. WHEN TESTED OUTSIDE THE PATIENT, HALF OF THE BALLOON DEFLATED AFTER ABOUT 45 MINUTES. IT IS THE 3RD TIME THIS PROBLEM OCCURRED WITH THE SAME SIZE OF BALLOON AND THE SAME COMPANY. THE LOT NUMBERS OF THE OTHERS ARE UNKNOWN. THE DEVICE HAD TO BE REINSTALLED 3 TIMES IN 6 DAYS FOR THE SAME PATIENT. THERE WAS HARM TO THE USER BECAUSE THE BUTTON HAD TO BE REINSTALLED ON THE PATIENT. THERE WAS AN INJURY AT THE INSERTION SITE TO HOLD THE BUTTON IN PLACE. SO THE GASTRO BUTTON IS NOT WORKING PROPERLY AS EXPECTED. WE THEREFORE REQUEST 3 GASTRO BUTTONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19384380 ↗
• MalfunctionDec 5, 2022Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT AT THE TIME OF THE PROCEDURE, THE NURSE SAW THAT THE BALLOON WAS PUNCTURED. THE NURSE PUT THE AIR PRESSURE AT 5 ML AND SOMETIME LATER, IT DROPPED TO 3 ML THEN TO 2 ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15918913 ↗
• MalfunctionJul 13, 2022Deflation Problem; Deflation Problem

  THE CUSTOMER REPORTED THE CLIENT BOUGHT A BUTTON AND IT DIDN'T LAST MORE THAN THREE WEEKS. THE DAMAGE IT PRESENTS IS IN THE LOWER PART, WHICH IS THE PART IN THE STOMACH. ADDITIONAL INFORMATION RECEIVED STATED THE BALLOON HAD A HOLE IN IT AND DEFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14999725 ↗
• MalfunctionJun 8, 2022Material Rupture; Material Rupture

  CUSTOMER REPORTS: THERE WAS A BALLOON DISRUPTION AFTER 16 DAYS OF USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14633865 ↗