CARDINAL HEALTH 8884711253ERecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10192253011296), received between Oct 16, 2025 and Sep 18, 2026 — classified as 3 injuries, 5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Difficult to Remove

  Patient problems: Needle Stick/Puncture

  MAUDE report 50820916 ↗
• MalfunctionSep 18, 2026Difficult to Remove

  Patient problems: Needle Stick/Puncture

  MAUDE report 50820894 ↗
• MalfunctionSep 18, 2026Difficult to Remove

  Patient problems: Needle Stick/Puncture

  MAUDE report 50820823 ↗
• InjuryJun 10, 2026Material Separation

  THE CUSTOMER REPORTED A DOBHOFF WAS PLACED FOR A CRITICAL PATIENT IN ICU. THE DOBHOFF BECAME OCCLUDED, WHICH DOES OCCUR FROM TIME TO TIME. STAFF DID THE PROTOCOL TO UNCLOG THE TUBE WITH THE ENZYME (PANCRELIPPASE 12,000U IN A 0.4% SODIUM BICARB). THIS ENZYME IS PART OF THE TUBE FEEDING ORDER SET. THIS ENZYME UNCLOGGED THE DOBHOFF FOR AROUND 2 HOURS. 2 HOURS LATER THE TUBE WAS CLOGGED AGAIN SO STAFF DECIDED TO PULL THE TUBE AND TO REPLACE WITH A NEW ONE PER PHYSICIAN ORDER. IT WAS AN EASY PULL OUT, HOWEVER WHEN THEY PULLED THE TUBE, THEY NOTICED THE END OF THE TUBE WAS MISSING. UPON X-RAY, IT WAS OBSERVED THAT THE END OF THE DOBHOFF REMAINED IN THE STOMACH. THIS PATIENT THEN HAD TO HAVE A PROCEDURE TO REMOVE THE END THAT WAS REMAINING IN THE STOMACH. PER ADDITIONAL INFORMATION PROVIDED ON JUNE 09, 2026, THE FEEDING TUBE WAS IN PLACE FOR 12 HOURS BEFORE THE OCCLUSION ALARM OCCURRED. THERE WERE ALARMS FOR DISLODGED TUBE THROUGHOUT HALF OF THE MORNING. THE PLACEMENT WAS ROUTINE, THE STYLET REMOVAL WAS UNEVENTFUL, AND PLACEMENT WAS CONFIRMED VIA X-RAY. THE TUBE WAS NOT REPOSITIONED AFTER PLACEMENT NOR WAS THE STYLET EVER REINSERTED. OTHER THAN THE ENZYME USED, COKE AND WARM WATER WERE AL

  Patient problems: Foreign Body In Patient

  MAUDE report 25461822 ↗
• MalfunctionJun 2, 2026Break

  THE CUSTOMER REPORTED A FEEDING TUBE WAS FOUND TO HAVE RUPTURED 26CM FROM THE END OF THE TUBE. THIS WAS FOUND DURING AN EGD. THE PATIENT WAS NOT HARMED. PER ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2026, THE RUPTURED TUBE WAS FOUND INCIDENTALLY ON AN UPPER GI ENDOSCOPY PERFORMED, INDICATION: MELENA. THE RUPTURED TUBE WAS FRACTURED BUT STILL IN ONE PIECE, IT DID NOT SEPARATE. THE TUBE WAS REMOVED AND REPLACED WITH A NEW TUBE TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25365124 ↗
• MalfunctionMay 7, 2026Difficult to Remove

  THE CUSTOMER REPORTED FOUR SEPARATE FEEDING TUBES KINKED ABOVE THE WEIGHTED TIP AND THEY WERE UNABLE TO UNKINK OR FLUSH. THIS WAS ATTEMPTED UNDER ENDOSCOPIC GUIDANCE. PHYSICIAN ALSO REPORTED THE STYLET IS STIFF/STUCK AND DIFFICULT TO MOBILIZE. PER ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER ON (B)(6) 2026, ALL FOUR DEVICES WERE USED WITH THE SAME PATIENT. THE FACILITY INSERTS THESE TUBES IN ENDOSCOPY AT THE REQUEST OF THE PHYSICIAN TO ENSURE ADEQUATE PLACEMENT. IT WAS CONFIRMED THAT PRIOR TO PLACEMENT 10ML OF WATER WAS INJECTED INTO THE TUBES AND THE WEIGHT ASSEMBLIES WERE SUBMERGED IN WATER FOR AT LEAST 5 SECONDS TO ACTIVATE THE HYDROMER COATING AND ONCE THE TUBE POSITION WAS CONFIRMED, THE HYDROMER COATING WAS REACTIVATED WITH ANOTHER 10ML OF WATER BEFORE ATTEMPTING TO REMOVE THE STYLET. THE ISSUE WASN¿T RESOLVED UNTIL THEY FOUND A TUBE THAT DIDN¿T KINK. THE AFFECTED TUBES WERE REMOVED AND DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25117029 ↗
• InjuryNov 18, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE CUSTOMER REPORTED THE GUIDEWIRE OF A FEEDING TUBE WAS NOT REMOVED AFTER INSERTION. THE PORT AND THE GUIDEWIRE LOOK ALIKE AND ARE THE SAME COLOR MAKING DIFFERENTIATION DIFFICULT FOR AN INEXPERIENCED CLINICIAN TO DETERMINE THE DIFFERENCE. PER ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 05, 2025, THERE WAS NO SPECIFIC INJURY THAT RESULTED TO THE PATIENT BUT THIS EVENT MET THEIR REPORTABILITY REQUIREMENT UNDER UNINTENTIONAL RETAINED FOREIGN ITEM. WHEN THEY REFER TO A RETAINED FOREIGN ITEM, THEY ARE REFERRING TO THE STYLET THAT WAS LEFT INSIDE THE NG TUBE THAT WAS INSERTED INTO THE PATIENT ONLY. THE ENTERAL FEEDING TUBE WAS REMOVED ENTIRELY BUT NOT REPLACED AS THE FAMILY FINALLY AGREED ON PEG TUBE INSERTION WHICH WAS DONE 3 DAYS AFTER THE RETAINED FOREIGN ITEM DISCOVERY. THE PATIENT WAS SENT BACK TO THE ED BECAUSE OF THE TUBE FEEDING MALFUNCTION ON (B)(6) 2025, THE PEG TUBE WAS INSERTED ON (B)(6) 2025, AND THEY WERE DISCHARGED (B)(6) 2025. PER FURTHER INFORMATION PROVIDED ON (B)(6) 2025, THE PATIENT PRESENTED TO (B)(6) ON (B)(6) 2025 FROM THE (B)(6) DUE TO THE FEEDING TUBE BEING PULLED OUT BY PATIENT AND WAS REPLACED. HE WAS DISCHARGED BACK ON (B)(6) 2025 TO (B)(6). THE PATIENT WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23586264 ↗
• InjuryOct 16, 2025Material Separation; Material Separation

  THE CUSTOMER REPORTED THE PATIENT WAS ADMITTED ON (B)(6) 2025 FOR ELECTIVE SURGERY WITH A DIAGNOSIS OF PANCREATIC HEAD NEOPLASM, AT WITCH TIME A NASOGASTRIC ENTERIC TUBE WAS PLACED (DOBBHOF W/ 12FR ENFIT). ON (B)(6) 2025, THE PATIENT PRESENTED WITH REGURGITATION OF FEEDING THROUGH THE FEEDING TUBE ASPIRATION TUBE LEVIN TYPE. THE SNE WAS POSITIONED IN THE JEJUNAL LOOP WHEN IT RUPTURED, AND THROUGH AN ENDOSCOPIC EXAM ITS DISTAL END WAS REMOVED. IT WAS LOCATED IN THE PROXIMAL THIRD, 19CM FROM THE UPPER DENTAL ARCH, PAST CRICOPHARYNGEUS.

  Patient problems: Gastrointestinal Regurgitation

  MAUDE report 23311113 ↗