Is this your brand? Sign in to claim ownership.

Argon Medical Devices, Inc.

United States·US-MF-000002324

Last updated September 17, 2026

About

Argon Medical Devices develops innovative Interventional Medical Devices & products for interventionalists & specialists to improve efficacy.

From the manufacturer's own website. Source

What Argon Medical Devices, Inc. makes

Argon Medical Devices manufactures single-use vascular and interventional devices, including catheter introduction sets, biopsy handpieces, wound drains, guidewires for cardiac and peripheral vascular procedures, percutaneous drainage catheters, and implantable radiological markers. The portfolio also covers intravascular extraction tools and needle guides for precision interventions.

These devices are classified under FDA regulations as Class I or Class II (including Class IIa), with listings in the FDA’s Unique Device Identifier (UDI) database and the EU’s eudamed registry. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: United States
Address: 1445 Flat Creek Road, Athens, Texas, United States
Website: www.argonmedical.com
LinkedIn: linkedin.com/company/argon-medical
Facebook: facebook.com/argonmedical
Email: [email protected]
Phone: 1.800.927.4669
PRRC Contact: Scott Bishop
EUDAMED SRN: US-MF-000002324
FDA FEI Number: 1417485
DUNS Number: —

Catalogue (1985)

Page 3 of 40

Device	Model / Reference	Registries	Class	Status
ArgoTrans Model 1	041517504A	FDA UDI	Class II	Unknown
SuperCore™ Biopsy Instrument	701120150	FDA UDI	Class II	Active
Co-Axial Cannula Bundle	MCXB1825BX	FDA UDI	Class II	Active
Med-Syringe	382022	FDA UDI	Class II	Unknown
Manifold Extension Set	194873	FDA UDI	Class II	Unknown
TLAB Transjugular Liver Access Biopsy System	TL-19	FDA UDI	Class II	Active
Screw Dilator	630838025	FDA UDI	Class I	Unknown
Neonatal Custom Kit	042915100AT	FDA UDI	Class II	Unknown
ArgoTrans Model 1	041516504A	FDA UDI	Class II	Unknown
Breast Localization Needles	252125	EUDAMEDFDA UDI	Class I	Active
Atrieve™ Vascular Snare Kit	382007045	FDA UDI	Class II	Active
PAC Tray/5 Catheter Introducer Tray	497424	FDA UDI	Class II	Active
SKATER™ All Purpose and Nephrostomy Drainage Set	756608035	FDA UDI	Class I	Active
Control Syringe	193239	FDA UDI	Class II	Unknown
Chiba Biopsy Needle	CFN-2220	FDA UDI	Class II	Unknown
Guidewire	395337	FDA UDI	Class II	Unknown
Centesis Procedure Tray	ATPT1000SDF	FDA UDI	Class I	Unknown
Westcott Needle	WFN-2220	FDA UDI	Class II	Unknown
Long Sheath Introducer	490005	FDA UDI	Class II	Unknown
Breast Localization Needles	231125G	EUDAMEDFDA UDI	Class I	Active
Guidewire	395420	FDA UDI	Class II	Active
Worker™ Guidewire	110535260	FDA UDI	Class II	Unknown
Centesis Procedure Tray	A30-CE3CO	FDA UDI	Class I	Unknown
Med-Syringe	382051	FDA UDI	Class II	Active
Adult EPD Femoral Angio Drape	396100	FDA UDI	Class II	Active
Amniocentesis Tray	A4545A	FDA UDI	Class I	Unknown
Pro-Mag™ Biopsy Needle	765016200	FDA UDI	Class II	Active
Bone Marrow Harvest Needle	BMHN1104BX	FDA UDI	Class II	Active
Centesis Procedure Kit	ATPK1005	FDA UDI	Class I	Unknown
Special Right Heart Kit	496413Y	FDA UDI	Class II	Unknown
Double Cath Lab Kit	194498A	FDA UDI	Class II	Unknown
T-Lok™ Bone Marrow Tray	BMT1104TLLF	FDA UDI	Class II	Active
Skater™ Single Step Drainage Set	756008030E	FDA UDI	Class I	Active
SKATER™ All Purpose and Nephrostomy Drainage Set	756606035	FDA UDI	Class I	Active
Manifold Kit	194306B	FDA UDI	Class II	Unknown
SKATER™ All Purpose and Nephrostomy Drainage Set	756607035	FDA UDI	Class I	Active
Arterial Line Pack	498415C	FDA UDI	Class I	Unknown
Worker™ Guidewire	124035090	FDA UDI	Class II	Active
3rd Transducer Kit	194670	FDA UDI	Class II	Unknown
SuperCore Advantage™	801118060	FDA UDI	Class II	Active
Screw Dilator	631038025	FDA UDI	Class I	Unknown
L-Cath™ Midline S/L Midline Catheter Basic Kit	384631	FDA UDI	Class II	Active
Guidewire	393186	FDA UDI	Class II	Unknown
Breast Localization Needles	242075	EUDAMEDFDA UDI	Class I	Active
Equipment Cover	400005B	FDA UDI	Class II	Unknown
SKATER™ All-Purpose and Nephrostomy Drainage Set	756610045	FDA UDI	Class I	Active
Contrast Line	193351	FDA UDI	Class II	Unknown
5F Axcess Percutaneous Catheter Introducer Kit	496035	FDA UDI	Class II	Unknown
Nitinol Guidewire	190118080	FDA UDI	Class II	Active
ClosureFast™ Micro Introducer Sheath Set	MIS-6F11	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (100)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Argon Medical Devices, Inc. has 129 recall records initiated between June 22, 2004, and September 12, 2025, with statuses including open, classified, and terminated. The records cite issues such as incorrect needle and suture configurations in arterial line kits, mismatched guidewire and needle compatibility, packaging defects compromising sterility (e.g., blister forming, pouch seals, and inadequate closures), incorrect labeling (including product dimensions and gauge), and component detachment in semi-automatic biopsy instruments.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Sep 12, 2025	Z-0589-2026	—	open, classified	Due to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue could potential result in procedural delays and/or risk of venous intimal injuries if excessive force is applied
Jul 2, 2024	Z-3192-2024	—	open, classified	Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introduction of micro-organisms into the access site, which could lead to an infectious process, bacteremia, or sepsis.
Jun 14, 2024	Z-2638-2024	—	open, classified	Peripherally Inserted Central Catheter (PICC) is labeled 26G/1.9Fr x 30cm but package contains incorrect 26G/1.9Fr x 50cm PICC, which could lead to procedural delay.
Jun 8, 2023	Z-2239-2023	—	open, classified	There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism.
Jan 24, 2022	Z-0563-2022	—	open, classified	Guidewire included with two lots of Arterial Line Kits would not fit through the needle of the same kit. This could potentially lead to a slight delay in the procedure and minor blood loss.
Oct 4, 2021	Z-0354-2022	—	open, classified	Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments.
Jul 8, 2021	Z-2501-2021	—	open, classified	As a result of design changes, sheaths have exhibited cracking/breaking at the tips.
Dec 10, 2020	Z-1073-2021	—	terminated	Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for surgical intervention to preclude or reverse permanent damage to a body structure or permanent impairment of a body function.
Dec 10, 2020	Z-1072-2021	—	terminated	Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for surgical intervention to preclude or reverse permanent damage to a body structure or permanent impairment of a body function.
Dec 10, 2020	Z-1076-2021	—	terminated	Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for surgical intervention to preclude or reverse permanent damage to a body structure or permanent impairment of a body function.
Dec 10, 2020	Z-1075-2021	—	terminated	Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for surgical intervention to preclude or reverse permanent damage to a body structure or permanent impairment of a body function.
Dec 10, 2020	Z-1074-2021	—	terminated	Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for surgical intervention to preclude or reverse permanent damage to a body structure or permanent impairment of a body function.
Dec 10, 2020	Z-1077-2021	—	terminated	Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for surgical intervention to preclude or reverse permanent damage to a body structure or permanent impairment of a body function.
Jun 19, 2020	Z-2806-2020	—	terminated	Sterile introducer sheath set manufactured under one lot with different expiration dates.
Apr 26, 2020	Z-2109-2020	—	terminated	Tungsten coils of the guidewire included in the introducer kit were detaching.
Apr 8, 2020	Z-1937-2020	—	terminated	Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may be more difficult to tie. The curved needle requires the use of a needle driver, there is a risk of needle stick to the surgeon tries to do it with fingers instead.
Apr 8, 2020	Z-1936-2020	—	terminated	Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may be more difficult to tie. The curved needle requires the use of a needle driver, there is a risk of needle stick to the surgeon tries to do it with fingers instead.
Apr 8, 2020	Z-1938-2020	—	terminated	Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may be more difficult to tie. The curved needle requires the use of a needle driver, there is a risk of needle stick to the surgeon tries to do it with fingers instead.
Dec 4, 2019	Z-1792-2020	—	terminated	The stiffness of the soft end of the guidewire caused tissue perforation.
Dec 4, 2019	Z-1791-2020	—	terminated	The stiffness of the soft end of the guidewire caused tissue perforation.
Dec 2, 2019	Z-2427-2020	—	terminated	Incorrect product labeling.
Oct 16, 2018	Z-0296-2020	—	terminated	The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
Oct 16, 2018	Z-0295-2020	—	terminated	The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
Oct 16, 2018	Z-0294-2020	—	terminated	The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
Oct 16, 2018	Z-0288-2020	—	terminated	The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
Oct 16, 2018	Z-0292-2020	—	terminated	The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
Oct 16, 2018	Z-0291-2020	—	terminated	The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
Oct 16, 2018	Z-0293-2020	—	terminated	The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
Oct 16, 2018	Z-0290-2020	—	terminated	The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
Oct 16, 2018	Z-0289-2020	—	terminated	The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
May 11, 2017	Z-2252-2017	—	terminated	Argon Medical has received a complaint from one of their distributors of a potential packaging defect. The product is sealed in a pouch and the defect if present shows as a potential void or unsealed edge of the pouch.
Jan 18, 2017	Z-1194-2017	—	terminated	The recalling firm received a complaint from one of their customers of a potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.
Jan 18, 2017	Z-1196-2017	—	terminated	The recalling firm received a complaint from one of their customers of a potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.
Jan 18, 2017	Z-1195-2017	—	terminated	The recalling firm received a complaint from one of their customers of a potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.
Sep 8, 2016	Z-0051-2017	—	terminated	The supplier initiated a recall because affected lots of the micro-introducer have an outer diameter of the dilator hub that is slightly smaller than is capable of securing the dilator to the sheath
Feb 17, 2016	Z-1029-2016	—	terminated	The incorrect sheath was assembled to the device so that the size 7 products received 11 cm sheaths and the size 11 product received 7 cm sheaths.
Jun 18, 2015	Z-2189-2015	—	terminated	Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.
Jun 18, 2015	Z-2188-2015	—	terminated	Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.
Jun 5, 2014	Z-2696-2014	—	terminated	UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.
Jun 5, 2014	Z-2697-2014	—	terminated	UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.
Jun 5, 2014	Z-2698-2014	—	terminated	UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.
May 4, 2012	Z-1946-2012	—	terminated	Some of the kits may exhibit a potential defect with the pouch seal. The pouch issue may compromise the sterile barrier.
Mar 14, 2011	Z-2097-2011	—	terminated	Packaging for sterile tray has the potential to have a hole which could compromise sterility for the products inside.
Mar 14, 2011	Z-2088-2011	—	terminated	Packaging for sterile tray has the potential to have a hole which could compromise sterility for the products inside.
Mar 14, 2011	Z-2095-2011	—	terminated	Packaging for sterile tray has the potential to have a hole which could compromise sterility for the products inside.
Mar 14, 2011	Z-2085-2011	—	terminated	Packaging for sterile tray has the potential to have a hole which could compromise sterility for the products inside.
Mar 14, 2011	Z-2091-2011	—	terminated	Packaging for sterile tray has the potential to have a hole which could compromise sterility for the products inside.
Mar 14, 2011	Z-2094-2011	—	terminated	Packaging for sterile tray has the potential to have a hole which could compromise sterility for the products inside.
Mar 14, 2011	Z-2099-2011	—	terminated	Packaging for sterile tray has the potential to have a hole which could compromise sterility for the products inside.
Mar 14, 2011	Z-2083-2011	—	terminated	Packaging for sterile tray has the potential to have a hole which could compromise sterility for the products inside.
Mar 14, 2011	Z-2087-2011	—	terminated	Packaging for sterile tray has the potential to have a hole which could compromise sterility for the products inside.
Mar 14, 2011	Z-2086-2011	—	terminated	Packaging for sterile tray has the potential to have a hole which could compromise sterility for the products inside.
Mar 14, 2011	Z-2089-2011	—	terminated	Packaging for sterile tray has the potential to have a hole which could compromise sterility for the products inside.
Mar 14, 2011	Z-2093-2011	—	terminated	Packaging for sterile tray has the potential to have a hole which could compromise sterility for the products inside.
Mar 14, 2011	Z-2090-2011	—	terminated	Packaging for sterile tray has the potential to have a hole which could compromise sterility for the products inside.
Mar 14, 2011	Z-2101-2011	—	terminated	Packaging for sterile tray has the potential to have a hole which could compromise sterility for the products inside.
Mar 14, 2011	Z-2096-2011	—	terminated	Packaging for sterile tray has the potential to have a hole which could compromise sterility for the products inside.
Mar 14, 2011	Z-2098-2011	—	terminated	Packaging for sterile tray has the potential to have a hole which could compromise sterility for the products inside.
Mar 14, 2011	Z-2084-2011	—	terminated	Packaging for sterile tray has the potential to have a hole which could compromise sterility for the products inside.
Mar 14, 2011	Z-2092-2011	—	terminated	Packaging for sterile tray has the potential to have a hole which could compromise sterility for the products inside.
Mar 14, 2011	Z-2100-2011	—	terminated	Packaging for sterile tray has the potential to have a hole which could compromise sterility for the products inside.
Mar 29, 2010	Z-1738-2010	—	terminated	There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility of the products to be compromised.
Mar 29, 2010	Z-1739-2010	—	terminated	There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility of the products to be compromised.
Mar 29, 2010	Z-1740-2010	—	terminated	There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility of the products to be compromised.
Mar 29, 2010	Z-1737-2010	—	terminated	There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility of the products to be compromised.
Mar 29, 2010	Z-1743-2010	—	terminated	There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility of the products to be compromised.
Mar 29, 2010	Z-1744-2010	—	terminated	There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility of the products to be compromised.
Mar 29, 2010	Z-1745-2010	—	terminated	There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility of the products to be compromised.
Mar 29, 2010	Z-1742-2010	—	terminated	There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility of the products to be compromised.
Mar 29, 2010	Z-1741-2010	—	terminated	There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility of the products to be compromised.
Feb 26, 2009	Z-1297-2009	—	terminated	Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
Feb 26, 2009	Z-1299-2009	—	terminated	Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
Feb 26, 2009	Z-1290-2009	—	terminated	Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
Feb 26, 2009	Z-1307-2009	—	terminated	Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
Feb 26, 2009	Z-1280-2009	—	terminated	Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
Feb 26, 2009	Z-1275-2009	—	terminated	Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
Feb 26, 2009	Z-1272-2009	—	terminated	Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
Feb 26, 2009	Z-1305-2009	—	terminated	Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
Feb 26, 2009	Z-1284-2009	—	terminated	Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
Feb 26, 2009	Z-1269-2009	—	terminated	Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
Feb 26, 2009	Z-1273-2009	—	terminated	Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
Feb 26, 2009	Z-1278-2009	—	terminated	Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
Feb 26, 2009	Z-1302-2009	—	terminated	Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
Feb 26, 2009	Z-1285-2009	—	terminated	Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
Feb 26, 2009	Z-1298-2009	—	terminated	Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
Feb 26, 2009	Z-1292-2009	—	terminated	Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
Feb 26, 2009	Z-1295-2009	—	terminated	Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
Feb 26, 2009	Z-1268-2009	—	terminated	Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
Feb 26, 2009	Z-1286-2009	—	terminated	Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
Feb 26, 2009	Z-1300-2009	—	terminated	Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
Feb 26, 2009	Z-1281-2009	—	terminated	Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
Feb 26, 2009	Z-1276-2009	—	terminated	Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
Feb 26, 2009	Z-1271-2009	—	terminated	Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
Feb 26, 2009	Z-1279-2009	—	terminated	Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
Feb 26, 2009	Z-1303-2009	—	terminated	Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
Feb 26, 2009	Z-1288-2009	—	terminated	Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
Feb 26, 2009	Z-1306-2009	—	terminated	Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
Feb 26, 2009	Z-1289-2009	—	terminated	Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
Feb 26, 2009	Z-1274-2009	—	terminated	Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
Feb 26, 2009	Z-1283-2009	—	terminated	Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.