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CARDINAL HEALTH 8884720858ERecalls & reported problems

Cardinal Health 200, LLC · ENTRFLX 8FR 43IN W/STYLT&Y SITE With ENFit Connectors · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10192253011715), received between Dec 8, 2025 and Sep 25, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 1 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Material Separation2
  • Break1
  • Difficult to Remove1

Patient problems

  • Foreign Body In Patient3
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjurySep 25, 2026Material Separation

    The customer reported the end remained in the patient post removal and needed to be removed via endoscopy.

    Patient problems: Foreign Body In Patient

    MAUDE report 50900378 ↗
  • InjuryMay 8, 2026Material Separation

    THE CUSTOMER REPORTED THAT THE DOBHOFF TIP NG TUBE BROKE INTO TWO PIECES WHILE INDWELLING IN THE PATIENT. A PORTION OF THE FEEDING TUBE WAS RETAINED WITHIN THE PATIENT. THE BREAK OF THE TUBE OCCURRED AT THE AREA OF 5.6-8CM ON THE TUBE. THE TUBE WAS INDWELLING FOR 2 DAYS BEFORE BREAK. THE REMAINING PORTION OF TUBE WAS REMOVED ENDOSCOPICALLY. FEED HISTORY: JEVITY 1.5 CAL. WATER HISTORY: 11/13 30 ML Q4H: 1522, 1742, 2059, 11/14 50 ML Q4H: 0128, 0550, 0930, 1302, 1706, 2108, 11/15 100 ML Q4H: 0130, 0520, 0913, 1316, 1811, 2200. MEDICATION HISTORY: AMIODARONE, ASPIRIN, LIPITOR, LISINOPRIL, LOPRESSOR, MULTIVITAMIN, OXYCODONE, GYLCOLAX, SENAKOT-S, BRILINTA, TRAZADONE, POTASSIUM CHLORIDE. SUPPLEMENT HISTORY: PROSOURCE 60 ML TID, BANATROL 60 ML BID.

    Patient problems: Foreign Body In Patient

    MAUDE report 25126773 ↗
  • MalfunctionApr 30, 2026Difficult to Remove

    THE CUSTOMER REPORTED AN ISSUE WITH THE NASOGASTRIC TUBES. SEVERAL NURSES HAVE REPORTED A PROBLEM WHEN REMOVING THE GUIDE WIRE AFTER THE TUBE HAS BEEN INSERTED. THEY STATED THAT THEY PROPERLY MOISTENED THE TUBE BEFOREHAND. THE REPORTER STATED THEY TESTED A TUBE THEMSELF, AND THE GUIDE SLIDES CORRECTLY AFTER HUMIDIFICATION. PER ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2026, THE ISSUE THE NURSES WERE EXPERIENCING WAS THAT THEY WERE COMPLETELY UNABLE TO REMOVE THE STYLET. IT WAS STATED THAT THEY PUT WATER IN THE TUBE BUT THE PROCESS USED AND QUANTITY OF WATER INJECTED IS NOT KNOWN. TO RESOLVE THE ISSUES, THE FEEDING TUBE HAS BEEN REMOVED AND REPLACED. NO FURTHER INFORMATION IS AVAILABLE REGARDING SPECIFIC INCIDENTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25053389 ↗
  • MalfunctionDec 8, 2025Break; Break

    THE CUSTOMER REPORTED THE SECTION OF THE TUBE WITH THE WEIGHT DETACHED FROM THE TUBE AND REMAINED IN THE PATIENT'S STOMACH. A CONSULTATION HAD TO BE CARRIED OUT WITH ANESTHESIA AND GASTROENTEROLOGY FOR FOLLOW UP. THEY ARE AWAITING EVALUATION FOR SEDATION WITH GASTROSCOPY OR SURGERY UNDER GENERAL ANESTHESIA. PER ADDITIONAL INFORMATION PROVIDED ON NOVEMBER 25, 2025, THEY ARE WAITING FOR THE END OF THE TUBE TO COME OUT THROUGH THE NATURAL CHANNELS. THEY TAKE X-RAYS REGULARLY TO FOLLOW THE PATIENT'S JOURNEY. THE PATIENT IS STABLE AND DOING WELL. HE SHOULD BE TRANSFERRED TO PEDIATRICS SHORTLY.

    Patient problems: Foreign Body In Patient

    MAUDE report 23742947 ↗

Other Tubes, gastrointestinal (and accessories) devices

All Tubes, gastrointestinal (and accessories) devices →

Sources and updates

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