UMBILI-CATH Dual-Lumen Silicone (REF 4275005)Recalls & reported problems
Utah Medical Products, Inc. · A Dual-Lumen Silicone Umbilical Catheter, 5 French · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H67142750050), received between Nov 7, 2025 and Nov 7, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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
Most reported problems
Device problems
- Material Split, Cut or Torn1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 7, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
THE SURGEON WAS CONSULTED DUE TO OOZING AROUND THE UMBILICAL CORD THAT WOULD NOT CORRECT WITH ANY INTERVENTION. WHILE REMOVING 5FR DOUBLE LUMEN UMBILICAL CATHETER IT BROKE, AND 3 CM REMAINED IN THE PATIENT'S UMBILICUS. PATIENT REQUIRED A TRIP TO THE OR TO REMOVE RETAINED UVC THAT HAD BROKEN OFF WHEN PEDS SURGERY HAD TRIED TO REMOVE IT. INCIDENTAL FINDING IF A URACHAL REMNANT WAS FOUND BY SURGEON. THIS WAS CAUSE OF DIFFICULTIES WITH UVC AND UAC PLACEMENTS AND POSSIBLY REASON WHY UVC BROKE WHEN PEDS SURGERY TRIED TO REMOVE IT. THE REMNANT WAS DISCARDED, BUT THE REMAINING SAMPLE IS AVAILABLE FOR EVALUATION.
Patient problems: Foreign Body In Patient
MAUDE report 23499913 ↗
Other Catheter, Umbilical Artery devices
- Argyle 8888160333Cardinal Health, Inc. · CATHETER, UMBILICAL ARTERY2 deaths66 reports
- Argyle 8888160333Cardinal Health 200, LLC · CATHETER, UMBILICAL ARTERY1 recall7 reports
- Argyle 8888160341Cardinal Health 200, LLC · CATHETER, UMBILICAL ARTERY1 recall1 report
- Argyle 8888160556Cardinal Health 200, LLC · CATHETER, UMBILICAL ARTERY1 recall1 report
- Argyle 8888160119Cardinal Health 200, LLC · CATHETER, UMBILICAL ARTERY1 recall0 reports
- Argyle 8888160648Cardinal Health 200, LLC · CATHETER, UMBILICAL ARTERY1 recall0 reports
- Argyle 8888160325Cardinal Health 200, LLC · CATHETER, UMBILICAL ARTERY1 recall0 reports
- Argyle 8888160341Cardinal Health, Inc. · CATHETER, UMBILICAL ARTERY36 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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