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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

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 (1984)

Page 1 of 40

Device	Model / Reference	Registries	Class	Status
Connecting Tube	401012010	EUDAMED	Class I	Active
Connecting Tube	404022000	EUDAMED	Class I	Active
Connecting Tube	802020000	EUDAMED	Class I	Active
Connecting Tube	404040015	EUDAMED	Class I	Active
Connecting Tube	802021000	EUDAMED	Class I	Active
Connecting Tube	401012025	EUDAMED	Class I	Active
Peripheral Guidewires	105235082	EUDAMED	Class IIa	Active
Connecting Tube	404018015	EUDAMED	Class I	Active
Connecting Tube	404018030	EUDAMED	Class I	Active
Connecting Tube	403943015	EUDAMED	Class I	Active
Connecting Tube	401013050	EUDAMED	Class I	Active
Connecting Tube	404343030	EUDAMED	Class I	Active
Connecting Tube	401012050	EUDAMED	Class I	Active
Connecting Tube	404040030	EUDAMED	Class I	Active
Connecting Tube	404024000	EUDAMED	Class I	Active
Connecting Tube	404343015	EUDAMED	Class I	Active
Connecting Tube	401013080	EUDAMED	Class I	Active
Connecting Tube	401012080	EUDAMED	Class I	Active
Connecting Tube	404043015	EUDAMED	Class I	Active
Co-Axial Cannula Bundle	MCXB1815BP	FDA UDI	Class I	Active
Skater™ All-Purpose and Nephrostomy Drainage Set	756614025	FDA UDI	Class I	Active
Tru-Core® I Biopsy Needle	763314160	FDA UDI	Class II	Unknown
One-Piece Introducer Tray	497434	FDA UDI	Class II	Active
Halo™ Single Loop Snare Kit	383625065	FDA UDI	Class II	Active
Percutaneous Micro-Introducer Kit	497818	FDA UDI	Class II	Unknown
UltraStream Chronic Dialysis Catheter Peel Away Kit	32401540	FDA UDI	Class II	Unknown
OneStic Micro-Access Introducer	497868	FDA UDI	Class II	Active
Guidewire	395722	FDA UDI	Class II	Active
Guidewire	395205	FDA UDI	Class II	Unknown
ACN™ Biopsy Needle	ACN1625MF	FDA UDI	Class II	Unknown
Long Sheath Introducer	490009	FDA UDI	Class II	Unknown
Guidewire	395309	FDA UDI	Class II	Unknown
Vessel Dilator	392305	FDA UDI	Class II	Active
Worker™ Guidewire	114235150	FDA UDI	Class II	Unknown
Worker™ Guidewire	110135080	FDA UDI	Class II	Unknown
Guidewire	395183	FDA UDI	Class II	Unknown
Control Syringe	193211	FDA UDI	Class II	Unknown
SuperCore™ Biopsy Instrument	701118150	FDA UDI	Class II	Active
SKATER™ All Purpose and Nephrostomy Drainage Set	756614035	FDA UDI	Class I	Active
Guidewire	395980	FDA UDI	Class II	Unknown
UltraCore™ Biopsy Needle	762618160	FDA UDI	Class I	Active
Tru-Core® I Biopsy Needle	763320160	FDA UDI	Class II	Unknown
Needle Guide	LNGC2022YX	EUDAMEDFDA UDI	Class I	Active
Custom Bone Marrow Tray	CB0387TL	FDA UDI	Class I	Unknown
Coaxial SABD Biopsy Device	CS-2020-15-T	FDA UDI	Class II	Unknown
PCI Kit/4 Percutaneous Catheter Introducer	496166	FDA UDI	Class II	Unknown
V-Mark™ Breast Biopsy Site Marker	15 ga x 10.8 cm	FDA UDI	Class II	Active
L-CathTM PICC D/L	20GA (2.6F) x 60cm	FDA UDI	Class II	Active
Safety MST Accessory Kit	384823	FDA UDI	Class II	Active
Pro-Mag™ Biopsy Needle	765016100	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.

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.