Z-1306-2009

Hydrophilic Guidewire, Catalog Number: TVS3010, .035/150 cm, regular/angled/standard, sold as a single...

Name: Z-1306-2009 Hydrophilic Guidewire, Catalog Number: TVS3010, .035/150 cm, regular/angled/standard, sold as a single...
Creator: Argon Medical Devices, Inc
Published: 2009-02-26
License: https://open.fda.gov/license/

Argon Medical Devices, Inc / initiated 2009-02-26 / Terminated

FDA source

Argon Medical Devices, Inc began a recall of Hydrophilic Guidewire, Catalog Number: TVS3010, .035/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Total Vein... on 2009-02-26. The reason FDA records is "Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1306-2009
Status: Terminated
Initiated: 2009-02-26
Posted: 2009-05-26
Terminated: 2010-01-07
Recalling firm: Argon Medical Devices, Inc
Product: Hydrophilic Guidewire, Catalog Number: TVS3010, .035/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Total Vein Solutions, 901 Yale Street - Houston, Texas 77008, (713) 863-1600 Fax 713 863-1601, www.totalvein.com.
Product code: DQX Wire, Guide, Catheter
Reason for recall: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
FDA root cause: Other
Action: Argon Medical Devices Inc. issued an "Urgent Field Safety Notice" letter dated February 26, 2009 informing all consignees of the affected product. Consumers were asked to immediately quarantine and return any product remaining followed by completion and return of the provided response form via email or fax (1-903-677-9396). For further questions or additional information call Argon Medical Devices Inc. at 1-903-677-9319.
Quantity in commerce: 750 units
Distribution: Worldwide Distribution -- US including Puerto Rico and states of AL, CA, CO, FL, GA, IL, KS, LA, MA, MI, MN, MO, MT, NC, NJ, NV, NY, PA, SC, TN, TX, UT, VA and WI and countries of Germany, Thailand, Turkey and the Netherlands.
Product codes and lots: All lot codes.

Product code DQX

K011905Class IISniper Elite Model-or-E3872xx SeriesMaxxim Medical / cleared 2001-08-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)