NA P1UVC-3540Recalls & reported problems
Footprint Medical, Inc. · 3.5Fr Single Lumen Polyurethane Umbilical Catheter · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00858778006386), received between Dec 18, 2025 and Dec 18, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
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.
InjuryDec 18, 2025Break; Break
IT WAS REPORTED THAT UPON REMOVAL OF THE CATHETER, THE TIP BROKE OFF AND REMAINED IN THE UMBILICUS AND INTERVENTION WAS REQUIRED. THE TYPE OF INTERVENTION PERFORMED WAS NOT REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 23837836 ↗
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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