UMBILI-CATH Single-Lumen SiliconeRecalls & reported problems
Utah Medical Products, Inc. · A Single-Lumen Silicone Umbilical Catheter, 3.5 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 H67141735050), received between May 14, 2025 and May 14, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Human-Device Interface Problem” (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
- Human-Device Interface Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2025Human-Device Interface Problem; Human-Device Interface Problem
CUSTOMER REPORTED THE HARD PLASTIC HUB WAS REMOVED INADVERTENTLY FROM THE SILICONE HUB.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22020539 ↗
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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