Kangaroo B10FDRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885380177101), received between Jan 22, 2025 and May 15, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (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.

• MalfunctionMay 15, 2025Air/Gas in Device; Air/Gas in Device

  THE CUSTOMER REPORTED THAT AFTER A FEW MONTHS THE PUMP STARTED PASSING AIR. WHEN THERE WAS AIR IN THE TUBING, THERE WAS NO MESSAGE AND THE DEVICE CONTINUED. THE PUMP STARTED SHOWING ERROR #8, THEN DEFECTIVE CASSETTE. THIS HAPPENED WHILE FEEDING THE PATIENT. THE CASSETTE ISSUE HAPPENED WITH A NEW BAG THAT WAS WORKING THEN SUDDENLY THE PUMP INDICATED THAT IT WAS NO LONGER WORKING. ADDITIONAL INFORMATION RECEIVED STATED THE PUMP LETS AIR UP TO 6 CM LONG PASS THROUGH WITHOUT AN ERROR MESSAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22025781 ↗
• MalfunctionJan 22, 2025

  PUMP SET TO INFUSE/DELIVER FEEDS AT 59ML/HR. RN (REGISTERED NURSE) WENT IN AS PUMP WAS RINGING OCCLUSION. WHEN RN LOOKED AT FEED BAG, ALMOST ALL OF THE 240MLS SHE HAD JUST PLACED IN THE BAG WAS GONE (APPROXIMATELY 200MLS). DEVICE SAID 1ML DELIVERED. DELIVERED VIA J-TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21207219 ↗