CLASS II Device recall · Reported 30 Apr 2014 · FDA Enforcement Report

Merit Laureate Hydrophilic Guide Wire recalled by Merit Medical Systems

Merit Medical Systems is recalling Merit Laureate Hydrophilic Guide Wire, distributed nationwide in the US. The recall was initiated on 14 Apr 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot No. K556399, Expires 2016-10

Quantity recalled173

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1485-2014
FDA event ID: 68041
Recalling firm: Merit Medical Systems, South Jordan, UT
Classification: Class II
Status: Terminated
Recall initiated: 14 Apr 2014
FDA classified: 22 Apr 2014
Reported: 30 Apr 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

14 Apr 2014	Recall initiated by company
22 Apr 2014	Classified by FDA	+8 days
30 Apr 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm), 260 cm (102").

Where it was distributed

Worldwide Distribution: USA Nationwide and China. No military/govt/VA consignees.

Nationwide Virginia

Questions about this recall

Is Merit Laureate Hydrophilic Guide Wire recalled?

Yes. Merit Medical Systems recalled Merit Laureate Hydrophilic Guide Wire on 14 Apr 2014. The recall is Class II and its status is Terminated. Recall number Z-1485-2014.

Why was it recalled?

Which lots are affected?

Lot No. K556399, Expires 2016-10

Where was it sold?

Worldwide Distribution: USA Nationwide and China. No military/govt/VA consignees.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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