Kangaroo 716150Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521010987), received between Feb 9, 2022 and Jan 13, 2023 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE CUSTOMER REPORTED THE PROBE WAS BEING USED BY A CHILD WHO DETECTED THE LEAKAGE OF FOOD. ADDITIONAL INFORMATION RECEIVED STATED THE LEAK IS LOCATED IN THE TUBE WHERE IT MEETS THE END THAT STAYS OUTSIDE THE BODY. THERE WAS A SMALL CRACK. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16156912 ↗
• MalfunctionSep 7, 2022Material Rupture; Material Rupture

  THE CUSTOMER REPORTED THAT THE BALLOON RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15373935 ↗
• MalfunctionFeb 9, 2022Material Puncture/Hole; Material Puncture/Hole

  THE CUSTOMER REPORTED THAT THE BALLOON DID NOT INFLATE. NO INJURIES OCCURRED. PER ADDITIONAL INFORMATION PROVIDED ON 08-FEB-2022, THE ISSUE OCCURRED DURING PATIENT USE. THERE WERE HOLES/CRACKS OBSERVED IN THE BALLOON. THE PROBLEM WAS RESOLVED BY REMOVING AND REPLACING THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13502029 ↗