UMBILI-CATH Dual-Lumen Silicone (REF 4273505)Recalls & reported problems
Utah Medical Products, Inc. · A Dual-Lumen Silicone Umbilical Catheter, 3.5 French · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H67142735050), received between May 23, 2023 and Feb 9, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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
Most reported problems
Device problems
- Material Split, Cut or Torn2
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 9, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
ON 1/18/2024, CATHETER BROKE DURING REMOVAL BY PHYSICIAN ASSISTANT. THE REMAINING CATHETER WAS REMOVED WITH SUB XYPHOID SURGICAL RE-ENTRY.
Patient problems: Foreign Body In Patient
MAUDE report 18677307 ↗InjuryMay 23, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
ON (B)(6) 2023. THE CATHETER BROKE DURING REMOVAL. THE REMAINING PIECE REMAINED INTERNAL AND THE INFANT SUBSEQUENTLY HAD TO BE SHIPPED TO THE HIGHER LEVEL OF CARE FOR REMOVAL. THE REMAINING CATHETER WAS REMOVED AT ANOTHER FACILITY WITH INTERVENTIONAL RADIOLOGY.
Patient problems: Foreign Body In Patient
MAUDE report 16987272 ↗
Other Catheter, Umbilical Artery devices
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- 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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