CARDINAL HEALTH 8884721252ERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10192253011838), received between Jun 2, 2025 and Jul 7, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2026Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE RN WENT TO REMOVE THE GUIDEWIRE FROM PATIENT'S NG TUBE WHEN THE PURPLE CAP OF THE GUIDEWIRE CAME OFF. THE WIRE UNDERNEATH THE PURPLE CAP WAS SHARP AND CUT THE RN'S FINGER, RESULTING IN A POTENTIAL BLOOD AND BODY FLUID EXPOSURE. THE GUIDEWIRE WAS STILL ABLE TO BE REMOVED AFTER CAP FAILURE. THE RN HAD TO UNDERGO BBFE PROTOCOLS/TREATMENT AND STARTED PROPHYLACTIC MEDICATIONS. PER ADDITIONAL INFORMATION PROVIDED ON 22JUN2026, BBFE (BLOOD BODY FLUID EXPOSURE) PROPHYLAXIS TREATMENT IS A STANDARD TREATMENT FOR POTENTIAL EXPOSURE TO BBFE. AT THIS TIME, THE STAFF WAS STARTED ON THIS TREATMENT, HARM LEVEL UNKNOWN.

  Patient problems: Needle Stick/Puncture

  MAUDE report 25732517 ↗
• MalfunctionJun 4, 2026Difficult to Remove

  THE CUSTOMER REPORTED AN ISSUE THAT OCCURS QUITE FREQUENTLY IS THAT AFTER THE TUBE IS POSITIONED IN THE STOMACH, IT CAN BE EXTREMELY DIFFICULT TO WITHDRAW THE WIRE (STYLET). WHEN FORCE IS APPLIED, THE PURPLE CAP MAY DETACH, EXPOSING THE HOOKED WIRE UNDERNEATH. THIS CREATES A SAFETY RISK, AS THE EXPOSED WIRE CAN CAUSE CUTS IF NOT HANDLED CAREFULLY, AN INCIDENT THAT HAS ALREADY AFFECTED TWO OF THEIR RADIOLOGISTS. AS A RESULT, ONE RADIOLOGIST NOW REFUSES TO PULL ON THE CAP ALTOGETHER. INSTEAD, THEY HAVE TO USE A KELLY CLAMP TO REMOVE THE WIRE WHEN IT BECOMES STUCK, EVEN AFTER FLUSHING THE TUBE WITH WATER BEFOREHAND TO HELP LOOSEN IT. THE WIRE WAS TESTED PRIOR TO USE BY PULLING IT IN AND OUT OF THE TUBE. IN THIS INSTANCE THE STYLET WAS EVENTUALLY REMOVED BY PULLING VERY HARD AND USING A KELLY CLAMP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. PER FURTHER INFORMATION PROVIDED ON (B)(6) 2026, THE PURPLE CAP DID DETACH DURING THIS INCIDENT. HOWEVER, RADIOLOGISTS WERE NOT HARMED DURING THIS EVENT. THE MENTION OF TWO RADIOLOGIST WHO HAVE BEEN AFFECTED ARE REFERRING TO PRIOR INCIDENTS. THE HYDROMER COATING ON THE INNER DIAMETER OF THE TUBE WAS ACTIVATED BY INJECTING APPROXIMATELY 10

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25398467 ↗
• InjuryApr 1, 2026Material Separation

  THE CUSTOMER REPORTED A PATIENT WAS ADMITTED ON NEURO UNIT WHO CAME TO MDC ENDO FOR PEG TUBE PLACEMENT. WHEN NURSES FROM NEURO REMOVED HIS NG FEEDING TUBE, PART OF IT MUST HAVE BROKE OFF AND STAYED IN THE PATIENT'S STOMACH. THE NURSE WHO REMOVED IT WAS UNAWARE THAT THE TUBE HAD BROKEN OFF AND WAS LEFT IN THE PATIENT. WHEN THE DOCTOR DID AN ENDOSCOPY TO INSERT THE NEW PEG TUBE, HE FOUND THE SMALL PIECE OF THE NG FEEDING TUBE THAT BROKE OFF AND REMOVED IT FROM PATIENT'S STOMACH. IN THE PART OF THE TUBE THAT WAS LEFT INSIDE THE PATIENT, IT LOOKS LIKE LITTLE MEDICATION BEADS WERE PLUGGING THE TUBE. ON (B)(6) 2026, THE CUSTOMER CONFIRMED THAT THE PORTION OF THE TUBE THAT REMAINED IN THE PATIENT WAS REMOVED VIA THE ENDOSCOPY PERFORMED TO PLACE THE PEG TUBE, NO FURTHER SURGERIES/PROCEDURES WERE PERFORMED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24753643 ↗
• MalfunctionNov 14, 2025Difficult to Remove; Difficult to Remove

  THE CUSTOMER REPORTED THAT ON (B)(6), A 12F GASTRIC TUBE WAS PLACED IN A PATIENT AND AN X-RAY WAS TAKEN TO CONFIRM PLACEMENT, HOWEVER, THEY WERE THEN UNABLE TO REMOVE THE STYLET FROM THE PATIENT. IT TOOK SEVERAL ATTEMPTS AND TWO NURSES TO FINALLY GET IT OUT. WHEN IT WAS REMOVED, THEY WERE THEN UNABLE TO FLUSH THE FEEDING TUBE. IT WAS LIKELY KINKED, BUT THEY OPTED TO JUST REMOVE IT AND START OVER. A NEW TUBE WAS PLACED AND WORKED WITHOUT ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23557004 ↗
• MalfunctionJun 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE TUBE WAS REMOVED DUE TO THE X-RAY SHOWING SOMETHING WAS WRONG WITH THE TUBE THEN AN ABDOMINAL X-RAY SHOWED THE TIP OFF THE TUBE IN PATIENT¿S STOMACH. FOLLOWING DAY PATIENT WAS RE-X-RAYED TO SEE IF TIP WAS MAKING ITS WAY TO THE EXIT BUT WAS FOUND TO BE IN SAME POSITION. NO EXTRA PROCEDURE PLANNED, JUST MONITORING.

  Patient problems: Foreign Body In Patient

  MAUDE report 22126712 ↗