ARGON MEDICAL DEVICES, INC.

3020 adverse events · 159 recalls · 24 clearances · 12 inspections · 2 compliance actions · aggregated across 5 source records

Scorecard

Events per device across the 2,174-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.

MAUDE reports per device

0.084 ▼

182 in the last 12 months

Higher volume than 93% of companies with 10+ devices

Recalls per device

0.006 ▼

14 in the last 12 months

Higher volume than 98% of companies with 10+ devices

These are reporting-volume percentiles, not safety rankings — MAUDE counts have no denominator of devices in use, and recall attribution follows resolved links. A high percentile means more reports per registered device than peers, which can reflect market size, device criticality, or reporting practice as much as anything else.

Devices

2,174 device records · ordered by linked event volume.

Brand	Model	Product codes	Primary DI	Linked events
Option Elite Retrievable Vena Cava Filter System	352506070E	DTK	00886333217151	1164
Option Elite Retrievable Vena Cava Filter	352506070E	DTK	00886333217519	807
L-Cath™ S/L PICC S/L	26GA (1.9F) x 30cm	FOZ LJS	00886333209934	490
First PICC™ S/L Peripherally Inserted Central Catheter	384232	FOZ	00886333209750	454
Option Elite				344
L-CathTM PICC S/L	28 GA (1.2F) x 25cm	FOZ LJS	00886333209910	174
First PICC™ S/L Peripherally Inserted Central Catheter Basic Kit	384221	FOZ	00886333209743	148
BioPince Ultra Full Core Biopsy Instrument	360-1080-02	KNW	00886333224005	114
BioPince™ Full Core Biopsy Instrument	360-1580-01	KNW	00886333004355	74
ClosureFast Micro Introducer Sheath	MIS-7F07	DRE	00886333227532	66
Option Elite Retrievable Vena Cava Filter	352506100E	DTK	00886333222346	66
BioPince Ultra Full Core Biopsy Instrument	360-1080-03	KNW	00886333224012	63
BioPince™ Full Core Biopsy Instrument	360-1080-01	KNW	00886333004379	54
L-Cath™ D/L PICC	18GA (3.5F) 1.20 mm x 60 cm	FOZ LJS	00886333209866	51
SKATER™ Drainage Catheter	755108035E	GBQ	00886333000166	45
BioPince™ Ultra Full Core Biopsy Instrument	370-1080-02	KNW	00886333224067	39
BioPince Ultra Full Core Biopsy Instrument	360-1580-03	KNW	00886333224036	37
L-Cath PICC S/L	20 GA (3F) 1.0mm x 60cm	FOZ LJS	00886333209828	33
BioPince Ultra Full Core Biopsy Instrument	360-1580-02	KNW	00886333224029	31
Cleaner XT™ Rotational Thrombectomy System	700009XT	KRA	00886333222308	30
Skater™ Introducer System	651506300	GCB	00886333004515	30
BioPince Ultra Full Core Biopsy Instrument	360-2080-02	KNW	00886333224043	29
BioPince™ Full Core Biopsy Instrument	370-1580-01	KNW	00886333004362	28
TLAB Transjugular Liver Access Biopsy System	TL-19	DYB	00886333218516	28
SuperCore™ Biopsy Instrument	701118150	KNW	00886333005888	27
First PICC™ S/L Peripherally Inserted Central Catheter	384101	FOZ	00886333209644	21
Option Elite				20
BioPince™ Full Core Biopsy Instrument	370-1080-01	KNW	00886333004386	19
BioPince™ Full Core Biopsy Instrument	360-2080-01	KNW	00886333004348	19
First PICC™ S/L Peripherally Inserted Central Catheter	384157	FOZ	00886333209682	18

Showing 1–30 of 2,174Next →

Compliance actions

FDA warning letters and enforcement actions (full history).

Date	Type	Action	Firm
2014-07-03	WL	Warning Letter	Argon Medical Devices, Inc
2014-07-03	WL	Warning Letter	Argon Medical Devices, Inc

Facilities

Registered establishments with their latest FDA inspection outcome.

FEI	Name	Location	Last inspection	Watch
1625425	ARGON MEDICAL DEVICES INC.	ATHENS, TX, US	NAI
1417485	ARGON MEDICAL DEVICES, INC.	WHEELING, IL, US	NAI