Data / Medical devices / United States / Argon Medical Devices Inc.
Argon Medical Devices Inc.: FDA-registered device maker in Athens, TX, United States, 108 510(k) clearances
Argon Medical Devices Inc. is registered with the FDA (registration 1625425) in Athens, TX, United States. It lists 76 device types. The FDA files 108 510(k) clearances under its listings, the newest dated December 15, 2025. 30 recall events name it as the recalling firm (2 Class I). Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 1625425
- Address
- 1445 Flat Creek RD., Athens, TX, United States, 75751
- Owner or operator
- ARGON MEDICAL DEVICES, INC (9059795)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- January 9, 1993
- Registered through
- 2026
- Brand names listed
- 11 guage Bone Access Needles, ACN, SACN, Biopsy Needle, ARGON ANGIO FLUSHING SET, AVI Dual Lumen HydroPICC, AVI HydroMID, AVI HydroPICC, Abrivo Introducer, Access needles and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 108.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 15, 2025 | K253741 | VStick Vascular Access Set | DYB | Substantially Equivalent | Argon Medical Devices, Inc. | accessdata.fda.gov |
| August 1, 2024 | K241145 | TLAB® Transvenous Liver Biopsy System (TF-18C) | DYB | Substantially Equivalent | Argon Medical Devices, Inc. | accessdata.fda.gov |
| March 28, 2024 | K233909 | Cleaner Plus 18F Thrombectomy System - Cleaner Plus 18F Aspiration Catheter, Cleaner Plus 18F Handpiece with Maceration Wire, Cleaner Plus 18F Aspiration Canister | QEW | Substantially Equivalent | Argon Medical Devices, Inc. | accessdata.fda.gov |
| January 19, 2024 | K232679 | Cleaner Pro Thrombectomy System; Cleaner Pro Aspiration Catheter with Handpiece; Cleaner Pro Aspiration Canister | QEW | Substantially Equivalent | Argon Medical Devices, Inc. | accessdata.fda.gov |
| December 8, 2023 | K233432 | 10F Sheath and Dilator Set | DYB | Substantially Equivalent | Argon Medical Devices, Inc. | accessdata.fda.gov |
| November 30, 2023 | K230669 | L-Cath Single and Dual Lumen Catheters, L-Cath Midline Catheters | LJS | Substantially Equivalent | Argon Medical Devices | accessdata.fda.gov |
| June 1, 2023 | K231293 | Drakon and Sequre® Microcatheters | DQO | Substantially Equivalent | Accurate Medical Therapeutics | accessdata.fda.gov |
| May 22, 2023 | K230631 | Kodiak Dual Port Coaxial Introducer Kit | DYB | Substantially Equivalent | Argon Medical Devices | accessdata.fda.gov |
| July 1, 2022 | K213232 | NovaCore Semi-Automatic Biopsy Instrument | KNW | Substantially Equivalent | Argon Medical Devices | accessdata.fda.gov |
| May 4, 2022 | K213550 | HydroPICC 5F Dual Lumen Catheter | LJS | Substantially Equivalent | Access Vascular, Inc. | accessdata.fda.gov |
| February 24, 2022 | K211798 | Cleaner Plus Thrombectomy System | QEW | Substantially Equivalent | Argon Medical Devices, Inc. | accessdata.fda.gov |
| February 8, 2021 | K203069 | HydroMID | FOZ | Substantially Equivalent | Access Vascular, Inc. | accessdata.fda.gov |
| January 15, 2021 | K202141 | Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set | DYB | Substantially Equivalent | Argon Medical Devices, Inc. | accessdata.fda.gov |
| January 5, 2021 | K200963 | Halo Single-Loop Microsnare Kit | MMX | Substantially Equivalent | Argon Medical Devices, Inc. | accessdata.fda.gov |
| December 22, 2020 | K201489 | Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set | DYB | Substantially Equivalent | Argon Medical Devices, Inc. | accessdata.fda.gov |
| December 11, 2020 | K203487 | Drakon and Sequre Microcatheters | DQO | Substantially Equivalent | Accurate Medical Therapeutics, Ltd. | accessdata.fda.gov |
| October 23, 2020 | K202797 | Drakon and Sequre Microcatheters | DQO | Substantially Equivalent | Accurate Medical Therapeutics, Ltd. | accessdata.fda.gov |
| June 3, 2020 | K200268 | Halo Single-Loop Snare Kit | MMX | Substantially Equivalent | Argon Medical Devices, Inc. | accessdata.fda.gov |
| February 20, 2020 | K193015 | HydroPICC (PICC-142) | LJS | Substantially Equivalent | Access Vascular, Inc. | accessdata.fda.gov |
| December 17, 2019 | K191758 | Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit | MMX | Substantially Equivalent | Argon Medical Devices, Inc. | accessdata.fda.gov |
| January 26, 2018 | K173430 | SeQure® NF and SeQure® Microcatheters | DQO | Substantially Equivalent | Accurate Medical Therapeutics, Ltd. | accessdata.fda.gov |
| December 8, 2016 | K160785 | Worker Guidewire | DQX | Substantially Equivalent | Argon Medical Devices, Inc. | accessdata.fda.gov |
| April 16, 2015 | K143405 | Option (TM) ELITE Vena Cava Filter 100cm System | DTK | Substantially Equivalent | Rex Medical, L.P. | accessdata.fda.gov |
| December 19, 2014 | K141969 | FIRSTSTIC N INTRODUCER | DYB | Substantially Equivalent | Argon Medical Devices, Inc. | accessdata.fda.gov |
| November 14, 2014 | K141617 | CLEANER ROTATIONAL THROMBECTOMY SYSTEM | QEW | Substantially Equivalent | Rex Medical, L.P. | accessdata.fda.gov |
| December 17, 2013 | K133243 | OPTION ELITE VENA CAVA FILTER SYSTEM | DTK | Substantially Equivalent | Rex Medical, L.P. | accessdata.fda.gov |
| November 22, 2013 | K130730 | V-STICK VASCULAR ACCESS SET | DYB | Substantially Equivalent | Argon Medical | accessdata.fda.gov |
| June 1, 2012 | K120346 | CLEANER ROTATIONAL THROMBECTOMY SYSTEM | MCW | Substantially Equivalent | Rex Medical | accessdata.fda.gov |
| November 18, 2010 | K102043 | ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER | MSD | Substantially Equivalent | Rex Medical | accessdata.fda.gov |
| February 18, 2010 | K091029 | CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM) | MCW | Substantially Equivalent | Rex Medical | accessdata.fda.gov |
| July 1, 2009 | K091670 | BD L-CATH SINGLE AND DUAL LUMENT CATHETERS, MIDLINE CATHETER | LJS | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| June 4, 2009 | K081410 | OPTION VENA CAVA FILTER | DTK | Substantially Equivalent | Rex Medical | accessdata.fda.gov |
| January 24, 2008 | K073672 | SKATER BILIARY CATHETER | FGE | Substantially Equivalent | Angiotech | accessdata.fda.gov |
| March 29, 2007 | K070384 | ARGON CONTINUOUS FLUSH DEVICE | KRA | Substantially Equivalent | Argon Medical Devices, Inc. | accessdata.fda.gov |
| January 26, 2006 | K053518 | INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR | NEU | Substantially Equivalent | Medical Device Technologies, Inc. | accessdata.fda.gov |
| November 17, 2005 | K052169 | IMC SURGICAL DRAPES | KKX | Substantially Equivalent | International Medsurg Connection, Inc. | accessdata.fda.gov |
| March 3, 2004 | K032840 | ATRION MEDICAL QL INFLATION DEVICE | KOE | Substantially Equivalent | Atrion Medical Products, Inc. | accessdata.fda.gov |
| August 13, 2003 | K031442 | PBN GUIDEWIRES | DQX | Substantially Equivalent | Medical Device Technologies, Inc. | accessdata.fda.gov |
| April 21, 2003 | K030334 | T-SCIENTIFIC T-PAD | QSY | Substantially Equivalent | T-Scientific, Inc. | accessdata.fda.gov |
| November 6, 2002 | K022634 | CO-AXIAL INTRODUCER NEEDLE | DYB | Substantially Equivalent | Promex, Inc. | accessdata.fda.gov |
| October 18, 2002 | K022895 | ELCAM STOPCOCKS AND MANIFOLDS | FMG | Substantially Equivalent | Medical Device Consultants, Inc. | accessdata.fda.gov |
| May 31, 2002 | K021606 | EN-SNARE ENDOVASCULAR SNARE AND CATHETER | MMX | Substantially Equivalent | Medical Device Technologies, Inc. | accessdata.fda.gov |
| February 19, 2002 | K014239 | MEDSURG EQUIPMENT COVERS | MMP | Substantially Equivalent | International Medsurg Connection | accessdata.fda.gov |
| September 5, 2001 | K011790 | MICROCRUISER PLUS INTRODUCER SET | DYB | Substantially Equivalent | Medical Device Technologies, Inc. | accessdata.fda.gov |
| June 22, 2001 | K011270 | AUTOMATED CORE BIOPSY DEVICE | FCG | Substantially Equivalent | Promex, Inc. | accessdata.fda.gov |
| October 30, 2000 | K000620 | PBN FALLOPIAN TUBE CATHETER SYSTEM | MDG | Substantially Equivalent | Medical Device Technologies, Inc. | accessdata.fda.gov |
| September 7, 2000 | K001872 | I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411 | FPA | Substantially Equivalent | Codan US Corp. | accessdata.fda.gov |
| June 16, 2000 | K000433 | PBN HYSTERO-SALPINGOGRAPHY CATHETER SET | LKF | Substantially Equivalent | Medical Device Technologies, Inc. | accessdata.fda.gov |
| November 26, 1999 | K990808 | PBN DILATORS | FGE | Substantially Equivalent | Medical Device Technologies, Inc. | accessdata.fda.gov |
| May 20, 1999 | K990839 | TRU-CORE I REUSABLE BIOPSY INSTRUMENT | KNW | Substantially Equivalent | Medical Device Technologies, Inc. | accessdata.fda.gov |
| April 23, 1999 | K991097 | PBN DRAINAGE CATHETER GUIDEWIRES | KNY | Substantially Equivalent | Medical Device Technologies, Inc. | accessdata.fda.gov |
| January 8, 1999 | K983620 | MANAN SPINAL NEEDLES | BSP | Substantially Equivalent | Manan Medical Products, Inc. | accessdata.fda.gov |
| September 23, 1998 | K982960 | MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT | KNW | Substantially Equivalent | Medical Device Technologies, Inc. | accessdata.fda.gov |
| July 17, 1998 | K982085 | MEDICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSALE SEMI-AUTOMATIC BIOPDY INSTRUMENT | KNW | Substantially Equivalent | Medical Device Technologies, Inc. | accessdata.fda.gov |
| July 9, 1998 | K981956 | DEGANIA SILICONE IDENTI LOOPS | DXC | Substantially Equivalent | Degania Silicone , Ltd. | accessdata.fda.gov |
| April 23, 1998 | K980227 | MANAN GALACTOGRAPHY KIT | FMI | Substantially Equivalent | Medical Device Technologies, Inc. | accessdata.fda.gov |
| April 6, 1998 | K974745 | MANAN GWI GUIDE WIRE INTRODUCER | DRC | Substantially Equivalent | Medical Device Technologies, Inc. | accessdata.fda.gov |
| February 18, 1998 | K980226 | MANAN PRO-MAG AUTOMATIC BIOPSY SYSTEM | KNW | Substantially Equivalent | Medical Device Technologies, Inc. | accessdata.fda.gov |
| February 10, 1998 | K974543 | L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER | FOZ | Substantially Equivalent | Luther Medical Products, Inc. | accessdata.fda.gov |
| February 3, 1998 | K980196 | MD TECH BIOPSY SET FOR BONE AND BONE MARROW | KNW | Substantially Equivalent | Medical Device Technologies, Inc. | accessdata.fda.gov |
| January 30, 1998 | K980122 | MANAN SOFT TISSUE BIOPSY NEEDLES | KNW | Substantially Equivalent | Medical Device Technologies, Inc. | accessdata.fda.gov |
| January 30, 1998 | K980005 | MANAN D BAG | EXF | Substantially Equivalent | Medical Device Technologies, Inc. | accessdata.fda.gov |
| January 9, 1998 | K980004 | MANAN GENERAL PURPOSE INTRODUCER NEEDLE | KNW | Substantially Equivalent | Medical Device Technologies, Inc. | accessdata.fda.gov |
| January 9, 1998 | K974815 | MANAN(TM) INTRODUCER SHEATH/NEEDLE | FGE | Substantially Equivalent | Medical Device Technologies, Inc. | accessdata.fda.gov |
| January 9, 1998 | K974814 | MANAN(TM) SUPER-CORE BIOPSY NEEDLES | KNW | Substantially Equivalent | Medical Device Technologies, Inc. | accessdata.fda.gov |
| January 8, 1998 | K974766 | MANAN TECHNA-CUT ASPIRATION NEEDLE | KNW | Substantially Equivalent | Medical Device Technologies, Inc. | accessdata.fda.gov |
| January 8, 1998 | K974741 | MANAN ACCURA NEEDLE | GAA | Substantially Equivalent | Medical Device Technologies, Inc. | accessdata.fda.gov |
| January 8, 1998 | K974446 | MANAN AUTOMATIC CUTTING NEEDLE | KNW | Substantially Equivalent | Manan Medical Products, Inc. | accessdata.fda.gov |
| September 15, 1997 | K972263 | FIRST PICC CATHETER WITH DUAL LUMENS | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| September 15, 1997 | K972262 | FIRST PICC CATHETER | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| September 12, 1997 | K972254 | FIRST MIDCATH CATHETER | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| March 11, 1997 | K963388 | VESSEL DILATOR | DRE | Substantially Equivalent | Maxxim Medical | accessdata.fda.gov |
| January 6, 1997 | K964050 | FIRST MIDCATH CATHETER | FOZ | Substantially Equivalent | Becton Dickinson Vascular Access, Inc. | accessdata.fda.gov |
| December 17, 1996 | K963749 | HIGH PRESSURE INJECTION LINES | DTL | Substantially Equivalent | Maxxim Medical | accessdata.fda.gov |
| April 17, 1996 | K953522 | USCI IDEAL PTCA KIT | MAV | Substantially Equivalent | Ryder Intl. Corp. | accessdata.fda.gov |
| July 27, 1995 | K951447 | DYNABITE CARDIOVASCULAR BIOPSY FORCEPS | DWZ | Substantially Equivalent | Portlyn Corp. | accessdata.fda.gov |
| May 16, 1995 | K951214 | STERILE EQUIPMENT COVER | KKX | Substantially Equivalent | Gulfstream Medical | accessdata.fda.gov |
| February 24, 1995 | K944522 | MORGANSTERN PROSTATE STABILIZATION AND SEEDING KIT | IWJ | Substantially Equivalent | Medical Device Technologies, Inc. | accessdata.fda.gov |
| June 7, 1993 | K920755 | L-CATH PEEL AWAY SYSTEM CATHETER | LJS | Substantially Equivalent | Luther Medical Products, Inc. | accessdata.fda.gov |
| December 11, 1992 | K915301 | ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK | DTL | Substantially Equivalent | Advance Medical Designs, Inc. | accessdata.fda.gov |
| June 19, 1992 | K921418 | ULTRA-CORE BIOPSY NEEDLES | DWO | Substantially Equivalent | Medical Device Technologies, Inc. | accessdata.fda.gov |
| October 23, 1991 | K911710 | HEPARIN COATED THERMODILUTION CATH & ACCESSORIES | DQO | Substantially Equivalent | Sunscope Intl., Inc. | accessdata.fda.gov |
| September 27, 1991 | K912172 | SAFEWEDGE(TM) RELIEF VALVE DEVICE | KRB | Substantially Equivalent | Sunscope Intl., Inc. | accessdata.fda.gov |
| September 16, 1991 | K911732 | ADVANCE DISPOSABLE CONTROL SYRINGE | IZI | Substantially Equivalent | Advance Medical Designs, Inc. | accessdata.fda.gov |
| February 11, 1991 | K904987 | VIBRONICS AUTO CORE BIOPSY DEVICE (ACBD) | KNW | Substantially Equivalent | Vibronics | accessdata.fda.gov |
| January 15, 1991 | K904994 | CLOSED SYSTEM FLUSH SET | DXT | Substantially Equivalent | Argon Medical Corp. | accessdata.fda.gov |
| September 28, 1989 | K894157 | OBTURATOR | DYB | Substantially Equivalent | Argon Medical Corp. | accessdata.fda.gov |
| May 19, 1989 | K891022 | INTRODUCER FOR PTCA GUIDING CATHETERS | DYB | Substantially Equivalent | Argon Medical Corp. | accessdata.fda.gov |
| September 12, 1988 | K880288 | TRU-TRAC TORQUE GUIDEWIRE | DQX | Substantially Equivalent | N-S Medical Products | accessdata.fda.gov |
| May 20, 1988 | K881957 | HAWKINS-AKINS BLUNT NEEDLE ACCESS KIT | KNW | Substantially Equivalent | N-S Medical Products | accessdata.fda.gov |
| March 9, 1987 | K870523 | HAWKINS BREAST LOCALIZATION NEEDLE | GDM | Substantially Equivalent | N-S Medical Products | accessdata.fda.gov |
| May 20, 1986 | K860307 | PEEL AWAY & SPLIT SHEATH PERCU CATH INTRODUCER SET | DYB | Substantially Equivalent | Teleflex, Inc. | accessdata.fda.gov |
| September 29, 1983 | K832030 | HEPARIN COATED STAINLESS STEEL/TEFLON | DOX | Substantially Equivalent | Argon Medical Corp. | accessdata.fda.gov |
| June 2, 1982 | K821372 | DESERET INTRACATH INTRAVENOUS CATHETER | FOZ | Substantially Equivalent | Warner-Lambert Co. | accessdata.fda.gov |
| April 29, 1982 | K820883 | SEPTISLEEVE | DYG | Substantially Equivalent | Argon Medical Corp. | accessdata.fda.gov |
| June 22, 1979 | K791098 | SINGLE-USE MINI-BULLDOG | DXC | Substantially Equivalent | Med General | accessdata.fda.gov |
| December 15, 1978 | K782006 | MEDGENERAL SINGLE-USE BULLDOG | GDJ | Substantially Equivalent | Med General | accessdata.fda.gov |
| December 7, 1978 | K781744 | IV SET WITH GRADUATED CHAMBER | FPA | Substantially Equivalent | National Patent Development Corp. | accessdata.fda.gov |
| October 24, 1978 | K781333 | CENTRAL CATHETER TRAY | KGC | Substantially Equivalent | Argon Medical Corp. | accessdata.fda.gov |
| October 10, 1978 | K781558 | PRESSURE MONITORING INJECTION LINES | DQO | Substantially Equivalent | Cobe Laboratories, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 15, 2026 | 99333 | Class II | Ongoing | L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF: 384539; 18ga (3.5F) 1.15mm x 60cm, REF: 384464; Basic Kit 28GA (1.2F) x 25cm 1 Lumen), REF: 384516; 20ga (3F) 1.00mm x 60cm, REF: 38 | Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, inability to flush/aspirate catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, bloodstream | accessdata.fda.gov |
| June 1, 2026 | 99069 | Class I | Ongoing | Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. | accessdata.fda.gov |
| September 12, 2025 | 97626 | Class II | Ongoing | Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena | 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 | accessdata.fda.gov |
| July 2, 2024 | 95119 | Class II | Ongoing | BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 360-1580-03, 360-2080-01, 360-2080-02, 360-2080-03, 370-1080-01, 370-1080-02, 370-1080-03, 370-1580-0 | 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. | accessdata.fda.gov |
| June 14, 2024 | 94951 | Class II | Ongoing | L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539 | 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. | accessdata.fda.gov |
| June 8, 2023 | 92585 | Class II | Ongoing | Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797 | There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism. | accessdata.fda.gov |
| January 24, 2022 | 89439 | Class II | Ongoing | 1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6" | 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. | accessdata.fda.gov |
| October 4, 2021 | 88814 | Class II | Ongoing | SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM; 701114150/SUPERCORE BIOPSY INSTR 14GA X 15CM; 701116090/SUPERCORE BIOPSY INSTR 16GA X 9CM; 701118060/SUPERCORE BIOPSY INS | Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments. | accessdata.fda.gov |
| July 8, 2021 | 88520 | Class II | Ongoing | Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet or 17ga Needle) through the parenchyma. | As a result of design changes, sheaths have exhibited cracking/breaking at the tips. | accessdata.fda.gov |
| December 10, 2020 | 87000 | Class II | Terminated | Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18S, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/6f Straight Catheter, Sterile EO | 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. | accessdata.fda.gov |
| June 19, 2020 | 86036 | Class II | Terminated | ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer Products are stand-alone components, standard kits, or convenience kits built to user specifica | Sterile introducer sheath set manufactured under one lot with different expiration dates. | accessdata.fda.gov |
| April 26, 2020 | 85562 | Class II | Terminated | Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: The Skater Introducer System with radiopaque marker is intended for fine needle puncture and tissue di | Tungsten coils of the guidewire included in the introducer kit were detaching. | accessdata.fda.gov |
| April 8, 2020 | 85488 | Class II | Terminated | Arterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI: 00886333215652 - Product Usage: Arterial Catheters are indicated for use when in instances where continuous invasive blood pressure readings and/or fr | 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. | accessdata.fda.gov |
| December 4, 2019 | 85398 | Class I | Terminated | 0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO | The stiffness of the soft end of the guidewire caused tissue perforation. | accessdata.fda.gov |
| December 2, 2019 | 85426 | Class II | Terminated | BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle MCXS1615BP. QTY.: 5/CS - Product Usage: The disposable, automatic BioPince Full Core Biopsy Instrument is used to obtain multiple core s | Incorrect product labeling. | accessdata.fda.gov |
| October 16, 2018 | 83633 | Class II | Terminated | (1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL, REF 040183000A, 25/box, Sterile, Rx; and (2) Argon Medical Devices Double Male LL Adapter, Special Adapter to Co | The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product. | accessdata.fda.gov |
| May 11, 2017 | 77273 | Class II | Terminated | Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged Arterial Needle 7cm x 18G AMC/4; Clear Flashback Needle 7 cm x 19G AMC/4 Usage: Argon Arterial Access Needles are designed to prov | 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. | accessdata.fda.gov |
| January 18, 2017 | 76292 | Class II | Terminated | BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX Intended for the purpose of harvesting bone and/or bone marrow specimens | 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. | accessdata.fda.gov |
| September 8, 2016 | 75213 | Class II | Terminated | MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate placing a catheter through the skin into a vein or artery. | 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 | accessdata.fda.gov |
| February 17, 2016 | 73376 | Class II | Terminated | ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2.3mm) x 11 cm REF IS-7F11. Indicated for use in arterial and venous procedures requiring percutaneou | 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. | accessdata.fda.gov |
| June 18, 2015 | 71533 | Class II | Terminated | Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Marrow Aspiration Needle 15G x 4 MAX, Part Number DBMNI1504; Bone Marrow Aspiration Needle 16G x 2.688 MAX, Part Number DBMNI1601 | Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray. | accessdata.fda.gov |
| June 5, 2014 | 68521 | Class II | Terminated | UltraStream Chronic Hemodialysis Catheter Standard Kit; Model Number 32101524 (24 cm), 32101528 (28cm), 32101532 (32 cm), and 32101536 (36 cm) and 32102540 (40 cm). The Rex Medical UltraStream Chronic Hemodialysis Cathet | UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation. | accessdata.fda.gov |
| May 4, 2012 | 61832 | Class II | Terminated | Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek bag, Model/Part Number 688695, Argon Critical Care Systems, Singapore Pte. Ltd., 198 Yishun Avenue 7, Singapore 768028. The blood sampling set is | Some of the kits may exhibit a potential defect with the pouch seal. The pouch issue may compromise the sterile barrier. | accessdata.fda.gov |
| March 14, 2011 | 58289 | Not yet classified | Terminated | Argon Medical Devices Catheter Introducer Kit, PCI 5 Kit 7F, Part Number 496183, Lot Number 99767488 Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. For percutaneous int | Packaging for sterile tray has the potential to have a hole which could compromise sterility for the products inside. | accessdata.fda.gov |
| March 29, 2010 | 55234 | Not yet classified | Terminated | ARTERIAL LINE KIT Arterial Line Kit #2 20ga X 3" REF/REORDER NO. 194284 Labeled Sterile, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751. | 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. | accessdata.fda.gov |
| February 26, 2009 | 51284 | Not yet classified | Terminated | Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087301,.035/150cm, regular/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Argon Medical Devices, In | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. | accessdata.fda.gov |
| January 6, 2009 | 54172 | Not yet classified | Terminated | Percutaneous Catheter Introducer Set, VNUS Medical Technologies Cath Shth Intro 7F x 7cm, catalog number IS-7F07, Disposable, Single Use, Do Not Re-sterilize, Manufactured in USA for VNUS, 5799 Fontanus Way, San Jose CA | One lot of Percutaneous Catheter Introducer Set contained incorrect size needle. | accessdata.fda.gov |
| November 19, 2007 | 45857 | Not yet classified | Terminated | Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG087312,.035/300cm, stiff/angled/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging c | Degradation -- Hydrophilic guidewires may exhibit degradation of blue Pebax cladding causing particulate to dislodge potentially resulting in embolism. | accessdata.fda.gov |
| June 27, 2005 | 32510 | Not yet classified | Terminated | Product consists of a syringe used to inject fluids during an angiographic procedure for fluoroscopic imaging. Labeling is as follows: Product Label ''***Argon Medical Device***10cc Control Syringe FR/TR/FM w/ Reservoir | The firm is recalling the product due to the potential for air aspiration or fluid leakage from a faulty syringe tip. | accessdata.fda.gov |
| June 22, 2004 | 29397 | Not yet classified | Terminated | Argon Medical Devices, Vesseloops, Blue Maxi, Two Latex free silicone vessel ties. Quantity: 1 box of 10 each (2 per pouch), sterilized by ETO, Federal law restricts this device to sale by or on the order of a physician. | Inadequate closure compromising sterility. | accessdata.fda.gov |
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Updated July 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.