CARDINAL HEALTH 8884720825ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10192253011654), received between Nov 24, 2025 and Feb 10, 2026 — classified as 2 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. 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.

• MalfunctionFeb 10, 2026Difficult to Remove

  THE CUSTOMER REPORTED THEY HAVE SIGNIFICANT PROBLEMS REMOVING THE MANDREL DURING EACH INSTALLATION. THIS HAS RESULTED IN TREATMENT FAILURES AND COMPLAINTS FROM FAMILIES. THEY EVEN TRIED REMOVING THE MANDREL BEFORE INSTALLATION, BUT THIS WAS NOT SUCCESSFUL. ACCORDING TO THE CUSTOMER, THE PACKAGING DOES NOT INCLUDE ANY INFORMATION THAT WOULD ENABLE THEM TO PROVIDE SAFE AND EFFECTIVE CARE. THE CLINICIAN NURSE STATED THEY PUT THIS KANGAROO TUBING IN 2-3 TIMES A YEAR AND IT IS USUALLY APPLIED BY A GASTROENTEROLOGIST BUT ACCORDING TO THEIR DECISION, IT IS NOW APPLIED BY THE NURSE. THE LAST TIME WAS LAST WEEK, ON A CHILD, TWO YEARS OLD, AROUND 10 KG. WHEN THE KANGAROO TUBING WAS INSERTED, IT WAS IMPOSSIBLE TO REMOVE THE MANDREL. DURING 48 HOURS, THE CHILD HAD NOT BEEN FED THROUGH ANY TUBING. THE CHILD HAS AN IV DRIP TO SUPPLY WHAT WAS NEEDED. AFTER A FEW DAYS, THEY PUT IN A NORMAL NASOGASTRIC TUBE. NURSES HAVE ALSO MADE A TEST WITH THREE SAMPLES, OUT OF THE PATIENT, AND IT WAS NOT POSSIBLE TO REMOVE THE MANDREL, EXCEPT FOR FROM ONE TUBE ONLY. PER ADDITIONAL INFORMATION PROVIDED, THE CUSTOMER DID NOT ACTIVATE THE HYDROMER PRIOR TO OR AFTER PLACEMENT. THE PATIENT'S DIGESTIVE TRACT WAS IRRIT

  Patient problems: Sore Throat

  MAUDE report 24310512 ↗
• MalfunctionNov 24, 2025Break; Break

  THE CUSTOMER REPORTED THE 8FR NG TUBE TIP BROKE OFF WHILE IN PLACE. THE MOM NOTED RESISTANCE 1.5 WEEKS AGO FOLLOWING ADMINISTRATION OF MEDICATION BUT WAS EVENTUALLY ABLE TO FLUSH THE TUBE WITH WATER AGAIN. NO FURTHER ISSUES WERE NOTED BY THE FAMILY BUT UPON CT SCAN REVIEW BY RADIOLOGIST ON (B)(6), THE TIP OF NG TUBE WAS SEEN IN THE SMALL INTESTINE. THE PATIENT HAS NOT YET PASSED THE TIP OF NG TUBE BUT THE REMAINDER OF THE TUBE WAS REMOVED IN THE CLINIC. PER ADDITIONAL INFORMATION PROVIDED ON 24NOV2025, THE CT SCAN WAS PERFORMED ON (B)(6), NOT (B)(6) WHICH WAS INITIALLY REPORTED IN ERROR. THIS WAS A ROUTINE SCAN FOR MONITORING PURPOSES WITH REGARDS TO THE PATIENT'S MEDICAL HISTORY. AS OF LAST THURSDAY, THE TIP OF THE NG TUBE HAD NOT PASSED YET. PER FURTHER INFORMATION PROVIDED ON 02DEC2025, AS OF (B)(6), THE TIP OF THE NG TUBE HAD STILL NOT PASSED. PER ADDITIONAL INFORMATION PROVIDED ON 11DEC2025, THE TIP HAS NOT PASSED YET. THE CURRENT PLAN AS PER SURGERY IS TO WAIT AND LET IT PASS ON ITS OWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 23638820 ↗