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Kangaroo 461438ERecalls & reported problems

Cardinal Health, Inc. · Polyurethane Feeding Tube Radiopaque · Class 2

Adverse event reports
5
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521547148), received between Jun 2, 2020 and Dec 17, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 2 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Material Separation2
  • Break1
  • Fracture1
  • Material Integrity Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions4
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 17, 2025Material Separation; Material Separation

    THE CUSTOMER REPORTED A DEPARTMENT RETURNED A NASOGASTRIC TUBE WITH REFERENCE NUMBER (B)(4) AND BATCH NUMBER 2418709464 AS THE TUBE WAS CUT WHEN THE PACKAGING WAS CLOSED. TWENTY DEVICES FROM THEIR ORDER REMAIN IN STOCK WITH NO COMPLIANCE PROBLEMS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23829717 ↗
  • MalfunctionOct 10, 2024Material Separation; Material Separation

    THE CUSTOMER REPORTED THAT THE TUBE WAS CUT AT THE 7 MARKS ON THE TUBE. ACCORDING TO THE STAFF THEY HAVE SEEN THIS BEFORE WHERE THE TUBE HAS BEEN CUT BUT IT WAS MUCH MORE OBVIOUS PREVIOUSLY. THEY WERE THINKING THAT BECAUSE OF THE LENGTH OF THE TUBE IT SOMETIMES GETS CAUGHT WHEN HEAT SEALING THE PACKAGING. THIS TUBE WAS INSIDE OF A PATIENT IN THE NICU, AND THE REPORTED ISSUE WAS NOTICED ON REMOVAL. THERE WAS NO PATIENT HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20422692 ↗
  • MalfunctionOct 10, 2024Break; Break

    THE CUSTOMER REPORTED THAT THE TUBE HAD A HOLE IN IT AND WAS LEAKING GASTRIC FLUID.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20421123 ↗
  • MalfunctionJun 23, 2021Fracture; Fracture

    THE CUSTOMER REPORTED THE RN WAS GOING TO PLACE AN NG. WHEN THE RN OPENED THE PACKAGING OF THE NG TUBE, THE RN NOTICED THAT THE TUBE WAS SPLIT IN HALF. WHEN THE RN WAS INSPECTING THE TUBE, THE RN ALSO NOTICED THAT ON THE SIDE OF THE TUBE THERE WAS AN OPENING. THE RN REPACKAGED THE TUBE TO GIVE TO SUPERVISOR AND NOTIFIED THE SUPERVISOR OF THE EVENT. THAT SPECIFIC NG TUBE WAS NEVER INSERTED INTO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12051948 ↗
  • MalfunctionJun 2, 2020Material Integrity Problem; Material Integrity Problem

    THE CUSTOMER REPORTED THAT THEY RECEIVED THE TUBE WITH A DEFECTIVE TIP, IT LOOKED LIKE IT WAS CUT ACROSS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10111933 ↗

Other Gastrointestinal Tubes with Enteral Specific Connectors devices

All Gastrointestinal Tubes with Enteral Specific Connectors devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.