CARDINAL HEALTH 8884721088ERecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10192253011753), received between Sep 5, 2025 and Sep 17, 2026 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (4 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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Material Separation

  Patient problems: Foreign Body In Patient

  MAUDE report 50808394 ↗
• MalfunctionAug 21, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50378945 ↗
• MalfunctionMay 28, 2026Difficult to Remove

  THE CUSTOMER REPORTED PRIOR TO PLACEMENT, STAFF CHECKED THAT THE WIRE WOULD MOVE, AS THE CHARGE NURSE NOTED IT CAN BE DIFFICULT TO REMOVE THE WIRE ONCE PLACED. THE WIRE WAS PARTIALLY MOVED AND THEN REPLACED. AFTER THE NG TUBE WAS PLACED, THE WIRE WOULD NOT COME OUT. WHEN THE CHARGE NURSE PULLED ON IT, THE PURPLE END CAME OFF. IT SOUNDS LIKE STAFF WORKED FOR SOME TIME TO REMOVE THE WIRE AND WERE EVENTUALLY ABLE TO DO SO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25317687 ↗
• MalfunctionApr 8, 2026Material Separation

  THE CUSTOMER REPORTED THE KENDALL ENTRIFLEX NASOGASTRIC FEEDING TUBE SIZE 10 FRENCH X 43 INCHES BECAME UN-INTACT WHILE INSERTED IN THE GASTRIC TRACT. THE TUBE APPEARED TO HAVE EXPANDED CAUSING IT TO RUPTURE AND BECOME DETACHED FROM THE PROXIMAL PORTION OF THE TUBE. PROXIMAL PORTION OF THE TUBE WAS REMOVED FROM THE PATIENT BUT APPROXIMATELY 30 CENTIMETERS OF THE DISTAL PORTION REMAINS INSIDE THE GASTRIC TRACT. PER ADDITIONAL INFORMATION PROVIDED ON 08-APR-2026, TO RESOLVE THE ISSUE, ANOTHER FEEDING TUBE WAS PLACED. THE FOREIGN BODY WAS NEVER REMOVED FROM THE PATIENT AS THEY PASSED AWAY FROM ACUITY OF ILLNESS, NOT RELATED TO THE FEEDING TUBE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24816937 ↗
• MalfunctionMar 2, 2026

  KENDALL ENTRIFLEX NASOGASTRIC FEEDING TUBE SIZE 10 FRENCH X 43 INCHES BECAME UN-INTACT WHILE INSERTED IN THE GASTRIC TRACT. THE TUBE APPEARED TO HAVE EXPANDED CAUSING IT TO RUPTURE AND BECOME DETACHED FROM THE PROXIMAL PORTION OF THE TUBE. PROXIMAL PORTION OF THE TUBE WAS REMOVED FROM THE PATIENT BUT APPROXIMATELY 30 CENTIMETERS OF THE DISTAL PORTION REMAIN INSIDE THE GASTRIC TRACT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24489743 ↗
• MalfunctionFeb 17, 2026Difficult to Remove

  THE CUSTOMER REPORTED ONE OF THE NURSES WAS UNABLE TO PULL OUT THE STYLET, IT BROKE AND SHE PUNCTURED HER FINGER.

  Patient problems: Needle Stick/Puncture

  MAUDE report 24364604 ↗
• MalfunctionFeb 10, 2026Difficult to Remove

  THE CUSTOMER REPORTED NASOGASTRIC FEEDING TUBE WITH ENFIT CONNECTION TUBE DIFFICULTY. WHEN TRYING TO REMOVE THE STYLET AFTER PLACEMENT CONFIRMATION, IT COILS AND IS DIFFICULT TO REMOVE. PER THE CUSTOMER, NURSING IS HAVING TO ADMINISTER STERILE WATER FIRST TO LUBRICATE THE INSIDE OF THE TUBE, AND THEN THE STYLET WILL COME OUT. THIS IS AN ONGOING COMPLAINT/CONCERN FOR THEM. PER ADDITIONAL INFORMATION PROVIDED, IT IS UNKNOWN IF THE HYDROMER WAS ACTIVATED PRIOR TO PLACEMENT PER THE IFU, BUT 10ML OF WATER WAS INJECTED AFTER PLACEMENT AND THEN REMOVAL WAS SMOOTH. HOWEVER, ON A FEW OCCASIONS THEY NEEDED TO REMOVE THE ENTIRE SYSTEM AND START OVER. PER THE CUSTOMER, THIS IS A RECENT COMPLAINT FROM SEVERAL DIFFERENT NURSES JUST OVER THE PAST FEW MONTHS. THERE WERE NO ISSUES PREVIOUSLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24304492 ↗
• InjurySep 16, 2025Material Separation; Material Separation

  THE CUSTOMER REPORTED THE FEEDING TUBE BROKE INSIDE THE PATIENT AND NEEDED TO BE REMOVED VIA EGD.

  Patient problems: Foreign Body In Patient

  MAUDE report 23067016 ↗
• InjurySep 16, 2025Material Separation; Material Separation

  THE CUSTOMER REPORTED THE FEEDING TUBE BROKE INSIDE THE PATIENT AND NEEDED TO BE REMOVED VIA EGD.

  Patient problems: Foreign Body In Patient

  MAUDE report 23066983 ↗
• InjurySep 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT A CHARGE NURSE INSERTED A DOBBHOFF TUBE INTO A PATIENT ON THE PCU NEURO MEDICAL UNIT. AFTER INSERTION THEY NOTICED BLEEDING FROM THE NARES, SO THEY REMOVED THE DOBBHOFF AND FOUND THE TIP WAS GONE. XRAY PERFORMED AND THE TIP WAS FOUND IN THE STOMACH. PER ADDITIONAL INFORMATION RECEIVED, THE TIP OF THE TUBE NEEDED TO BE REMOVED VIA EGD.

  Patient problems: Foreign Body In Patient

  MAUDE report 22977044 ↗