Catheter, Umbilical Artery
General Hospital · 21 CFR 880.5200
Recent MDR events
1,545 adverse event reports on file
- Umbilical CatheterJul 31, 2026MalfunctionVygon Usa2245270-2026-00099
- 3.5F UMBILICAL CATHETERJul 15, 2026MalfunctionVygon Usa2245270-2026-00088
- UMBILICAL CATHETERJul 13, 2026MalfunctionVygon2245270-2026-00086
- 5F UMBILICAL CATHETERJun 18, 2026MalfunctionVygon2245270-2026-00078
- ARGYLEJun 17, 2026MalfunctionCardinal Health 200, Llc1423537-2026-00197
- ARGYLE 5FRENCH CATHETERJun 11, 2026InjuryCardinal Health 200, Llc.MW5189330
- UMBILICAL CATHETERJun 9, 2026MalfunctionVygon2245270-2026-00075
- UMBILICAL CATHETERMay 19, 2026MalfunctionVygon Usa2245270-2026-00063
- UTAH MEDICAL PRODUCTS 3.5F DOUBLE LUMEN UVC CATHETERMay 13, 2026InjuryUtah Medical Products, Inc.MW5188159
- UMBILI-CATHMar 31, 2026MalfunctionUtah Medical Products, Inc.1718873-2026-00001
Event type breakdown
Recalls
7 recall events for this product code
- Cardinal Health 200, LLCOpen, ClassifiedMay 29, 2025
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.
Z-1870-2025 · View FDA record ↗ - Cardinal Health 200, LLCOpen, ClassifiedMay 29, 2025
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.
Z-1871-2025 · View FDA record ↗ - Cardinal Health 200, LLCOpen, ClassifiedMay 29, 2025
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.
Z-1872-2025 · View FDA record ↗ - Cardinal Health 200, LLCOpen, ClassifiedMay 29, 2025
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.
Z-1873-2025 · View FDA record ↗ - Cardinal Health 200, LLCOpen, ClassifiedMay 29, 2025
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.
Z-1874-2025 · View FDA record ↗ - Cardinal Health 200, LLCOpen, ClassifiedMay 29, 2025
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.
Z-1875-2025 · View FDA record ↗ - Cardinal Health 200, LLCTerminatedAug 13, 2021
Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811).
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.
Z-2244-2021 · View FDA record ↗
Registered firms
50 firms currently registered for this product code
Gamamed Vascular Systems Inc.
Loveland, CO, US
Dimequip
Frameries Hainaut, BE
Cardinal Health
Hazelwood, MO, US
Cardinal Health 200, Llc
Waukegan, IL, US
Steritec Services, Llc
ATHENS, TX, US
Vygon Portugal
Balter-Paredes Porto, PT
Utah Medical Products, Inc.
Midvale, UT, US
Cardinal Health Costa Rica, S.a.
-- Alajuela, CR
Deroyal Industries, Inc.
POWELL, TN, US
Sterigenics U.s., Llc
Queensbury, NY, US
Bard Access Systems, Inc.
Salt Lake City, UT, US
Haolang Medical Usa Corporation
Clyde Hill, WA, US
Sipv
Ecouen Ile-de-France, FR
510(k) clearances
34 clearances for this product code
- Haolang Medical USA CorporationMay 6, 2021
K201697 · Umbilical Vessels Catheter
- Covidien Lp, Formerly Registered AS KendallApr 17, 2013
K130725 · MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR.
- Footprint Medical, Inc.Mar 1, 2012
K120304 · FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER
- Footprint MedicalSep 25, 2009
K091214 · FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER
- Footprint MedicalSep 25, 2009
K091213 · FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN
- Neomed, Inc.Jul 21, 2008
K081515 · NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0
- Neomed, Inc.Feb 22, 2008
K073596 · NEOMED SINGLE LUMEN UMBILICAL CATHETER
- Schiff & Co.Oct 1, 1998
K981630 · VYGON DOUBLE LUMEN UMBILICAL CATHETER