Z-2105-2010

Merit Laureate Hydrophylic Guide Wire, Angled Stiff Shaft, Made In Ireland, CAT No: LWSTFA35260EX, 260cm...

Name: Z-2105-2010 Merit Laureate Hydrophylic Guide Wire, Angled Stiff Shaft, Made In Ireland, CAT No: LWSTFA35260EX, 260cm...
Creator: Merit Medical Systems, Inc.
Published: 2010-06-28
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2010-06-28 / Terminated / root cause: manufacturing process

FDA source

Merit Medical Systems, Inc. began a recall of Merit Laureate Hydrophylic Guide Wire, Angled Stiff Shaft, Made In Ireland, CAT No: LWSTFA35260EX, 260cm, Sterile EO, Merit Medical Systems, Inc., South... on 2010-06-28. The reason FDA records is "Guidewires have decreased lubricity at the proximal end, inhibiting proper operation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2105-2010
Status: Terminated
Initiated: 2010-06-28
Posted: 2015-06-26
Terminated: 2010-10-19
Recalling firm: Merit Medical Systems, Inc.
Product: Merit Laureate Hydrophylic Guide Wire, Angled Stiff Shaft, Made In Ireland, CAT No: LWSTFA35260EX, 260cm, Sterile EO, Merit Medical Systems, Inc., South Jordan, UT 84095. Intended to facilitate the placement of devices during diagnostic and interventional procedures.
Product code: DQX Wire, Guide, Catheter
Reason for recall: Guidewires have decreased lubricity at the proximal end, inhibiting proper operation.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Merit Medical System, Inc., notified the Sales representatives by e-mail on June 28, 2010, and instructed them to contact all of their accounts and to advise them to discontinue use and return any unused products to Merit. A Product Recall Notice was to be completed by each facility under the direction of the rep and all activities were to be completed by July 9, 2010. Questions should be directed to Penny Goldman, Senior Product Manager at 801-208-4198 or Jackie Preece, Manager, Customer Service at 801-208-4365.
Quantity in commerce: 140 units
Distribution: Nationwide distribution: CA, CO, FL, GA, IL, IN, KS, MA, MD, MI, MN, NC, NH, NJ, NY, PA, and SD.
Product codes and lots: Lot Number K131835

Product code DQX

K092303Class IIMerit Laureate Hydrophilic Guide WireMerit Medical Systems, Inc. / cleared 2009-10-27

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)