Catheter, Umbilical Artery
FDA adverse event reports and recall history for catheter, umbilical artery (product code FOS), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,542
- Deaths
- 33
- Injuries
- 249
- Malfunctions
- 1,181
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-05-29Open, ClassifiedPackage design/selection
Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
- 2025-05-29Open, ClassifiedPackage design/selection
Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
- 2025-05-29Open, ClassifiedPackage design/selection
Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
- 2025-05-29Open, ClassifiedPackage design/selection
Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
- 2025-05-29Open, ClassifiedPackage design/selection
Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
- 2025-05-29Open, ClassifiedPackage design/selection
Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
- 2021-08-13TerminatedLabeling Change Control
Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umbilical Venous Catheter (UVC) into the umbilical artery or vein of neonate. Product Code: 43201
The current Argyle UVC Insertion Tray does not include a specific IFU to operate the Safety Scalpel N11. The Safety Scalpel N11 features a permanent locking feature that will not allow the clinician to unlock the scalpel once the safety shield is closed and pushed forward into a locked position may result in a delay treatment/therapy, which could ultimately result in death.
Monitor catheter, umbilical artery automatically
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