CARDINAL HEALTH 8884710826ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10192253011159), received between Jul 29, 2025 and Aug 11, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryAug 11, 2025Difficult to Remove; Difficult to Remove

  THE CUSTOMER REPORTED A CASE OF EXTREME DIFFICULTLY REMOVING THE DOBBHOFF TUBE WIRE WITH THE TUBE IN THE APPROPRIATE POSITION. IT WAS CONFIRMED THAT THE TUBE WAS FLUSHED AND THE WIRE WAS MOVING FREELY BEFORE INSERTION. CONFIRMED PROPER PLACEMENT ON XRAY WITH NO INDICATION OF ANY SHARP TURNS/KINKS WHICH WOULD HINDER WIRE REMOVAL. WHEN THE WIRE WAS ATTEMPTED TO BE REMOVED, IT REQUIRED EXTREME FORCE. THE TEAM REMOVED THE TUBE BEFORE TRYING TO USE FORCE TO REMOVE THE WIRE AND HAD THE SAME DIFFICULTLY WITH 3 DIFFERENT TUBES REQUIRING 3 DIFFERENT SETS OF XRAYS AND ULTIMATELY LEADING TO THE PATIENT HAVING BLOOD SECRETIONS/ASPIRATIONS LIKELY FROM TRAUMA DUE TO PROLONGED ATTEMPTED INSERTION. ULTIMATELY, THEY OBTAINED A 4TH TUBE FROM ANOTHER UNIT AND HAD SUCCESS. ADDITIONAL INFORMATION RECEIVED ON 23JUL2025 STATED THAT THE PATIENT ENDED UP HAVING HEMOPTYSIS AND ASPIRATION WITH HYPOXIA REQUIRING TRANSFER TO ICU. PATIENT RECEIVED INHALED TXA, HAD ENT PULL OUT CLOT. THE PATIENT ENDED UP NEEDING TO BE INTUBATED (THOUGH SHE ALSO HAD ISSUES WITH MENTAL STATUS AND ASPIRATED A TOOTH WHICH WAS UNRELATED). ULTIMATELY, SHE ENDED UP IN SEPTIC SHOCK. SHE DID NOT REQUIRE NASAL PACKING, BUT DID CONTINUE TO

  Patient problems: Aspiration/Inhalation; Hemoptysis; Hemorrhage/Blood Loss/Bleeding; Hypoxia; Septic Shock

  MAUDE report 22772713 ↗
• MalfunctionJul 29, 2025Fracture; Fracture

  THE CUSTOMER REPORTED THAT THEY HAD ONE DOCUMENTED AND MANY OTHER REPORTED CASES OF TUBES BEING FOUND "FRACTURED" ON XRAY REQUIRING IMMEDIATE REMOVAL BEFORE RISK OF FURTHER COMPLICATIONS. THE TUBES HAD NO OUTWARD INDICATIONS OF ANY MALFUNCTION BUT WAS CAUGHT BY RADIOLOGY ON XRAY FOR CONCERN FOR FRACTURED TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22656143 ↗