Z-1485-2014Class II

Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm)...

Name: Z-1485-2014 Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm)...
Creator: Merit Medical Systems, Inc.
Published: 2014-04-14
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2014-04-14 / Terminated / root cause: manufacturing process

FDA source

Merit Medical Systems, Inc. began a recall of Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm), 260 cm (102") on 2014-04-14. FDA classified it as Class II and gives the reason as "Discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035" 260 cm Guide Wire, catalog number LWSTFS35260EX, which has a straight tip and a stiff shaft. This lot was partially mixed with...". 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-1485-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-14
Posted: 2014-04-22
Terminated: 2014-07-17
Recalling firm: Merit Medical Systems, Inc.
Product: Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm), 260 cm (102").
Product code: DQX Wire, Guide, Catheter
Reason for recall: Discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035" 260 cm Guide Wire, catalog number LWSTFS35260EX, which has a straight tip and a stiff shaft. This lot was partially mixed with another lot of Laureate 0.035" 260 cm Guide Wire, catalog number LWSTDA35260EX, which has an angled tip, standard shaft and Chinese unit labeling.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Customers were notified on 4/14/14 via certified letter with instructions to identify product, discontinue use, and return products.
Quantity in commerce: 173
Distribution: Worldwide Distribution: USA Nationwide and China. No military/govt/VA consignees.
Product codes and lots: Lot No. K556399, Expires 2016-10

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1485-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1485-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-30	2014-04-22
Z-1486-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-30	2014-04-22

Product code DQX

K120644Class IIMerit Hydrophilic Guide WireMerit Medical Systems, Inc. / cleared 2012-09-19

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)