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CARDINAL HEALTH 8884711006ERecalls & reported problems

Cardinal Health 200, LLC · DOBBHOFF 10FR 43IN W/STYLET With ENFit Connectors · Class 2

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

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10192253011258), received between Jul 27, 2026 and Sep 24, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

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: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 1 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

  • Detachment of Device or Device Component1
  • Improper or Incorrect Procedure or Method1

Patient problems

  • Dehydration1
  • Hyponatremia1
  • Needle Stick/Puncture1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 24, 2026Detachment of Device or Device Component

    Patient problems: Needle Stick/Puncture

    MAUDE report 50890125 ↗
  • InjuryJul 27, 2026Improper or Incorrect Procedure or Method

    The customer reported the patient was found to have a Dobhoff feeding tube with the stylet still in place several days after placement which led to dehydration and hyponatremia. Per the customer, while the metal stylet is essential for placement of the tube, removal of the stylet is a challenge. The stylet plastic tip is the very same color as the ports on the feeding tube and can be difficult to differentiate easily for users. There are two ports, so inexperienced users may think the stylet is supposed to be there and use the smaller port, restricting the flow rate of feeds and fluids. Per additional information provided on July 21, 2026, the treatment for dehydration was IV fluids x 24hours. There was no treatment provided for the hyponatremia which resolved prior to discharge, monitoring only. The tube was in place for 5 days before the stylet was found to still be in the tube. The stylet was removed and the tube remained in place with placement confirmed by x-ray.

    Patient problems: Dehydration; Hyponatremia

    MAUDE report 50000546 ↗

Other Tubes, gastrointestinal (and accessories) devices

All Tubes, gastrointestinal (and accessories) devices →

Sources and updates

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