CLASS II Device recall · Reported 30 Apr 2014 · FDA Enforcement Report
Merit Laureate 035" Hydrophilic Guide Wire, Angled Tip recalled
Merit Medical Systems is recalling Merit Laureate 035" Hydrophilic Guide Wire, Angled Tip, Standard Shaft, 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
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-1486-2014
- 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
Merit Medical Systems, Inc. is voluntarily conducting a recall due to a discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035" 260 cm Guide Wire, catalog number LWSTFS35260EX, lot number K556399 (173 units), which has a straight tip and a stiff shaft. Lot K556399 was partially mixed with another lot of Laureate 0.035" 260 cm Guide Wire, catalog number LWSTDA3
Product as listed by the FDA
Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTDA35260EX, 260 cm (102").
Where it was distributed
Worldwide Distribution: USA Nationwide and China. No military/govt/VA consignees.
Questions about this recall
Is Merit Laureate 035" Hydrophilic Guide Wire, Angled Tip, Standard Shaft recalled?
Yes. Merit Medical Systems recalled Merit Laureate 035" Hydrophilic Guide Wire, Angled Tip, Standard Shaft on 14 Apr 2014. The recall is Class II and its status is Terminated. Recall number Z-1486-2014.
Why was it recalled?
Merit Medical Systems, Inc. is voluntarily conducting a recall due to a discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035" 260 cm Guide Wire, catalog number LWSTFS35260EX, lot number K556399 (173 units), which has a straight tip and a stiff shaft. Lot K556399 was partially mixed with another lot of Laureate 0.035" 260 cm Guide Wire, catalog number LWSTDA3
Which lots are affected?
Lot No. K556402, 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.
More recalls from Merit Medical Systems
All 144| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Splashwire Hydrophilic Guide Wire recalled by Merit Medical Systems | Merit Medical Systems | Packaging Defects | Nationwide |
| Device | CLASS II | Philips Bridge Prep Kit recalled by Merit Medical Systems | Merit Medical Systems | Sterility | Nationwide |
| Device | CLASS II | Philips Bridge Prep Kit recalled by Merit Medical Systems | Merit Medical Systems | Sterility | Nationwide |
| Device | CLASS II | Philips Bridge Prep Kit recalled by Merit Medical Systems | Merit Medical Systems | Sterility | Nationwide |
| Device | CLASS I | DuraMax Chronic Hemodialysis Catheter recalled by Merit Medical Systems | Merit Medical Systems | Device Malfunction | Nationwide |
Other Other Medical Devices recalls
All 13,771| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: Blood Draw Kit recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ortho Aspiration Kit recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep DYKA1054F recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Arterial Line Insertion Kit recalled | Medline Industries | Sterility | Nationwide |