FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc.: Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTDA35260EX, 260 cm (102").
- Recall number
- Z-1486-2014
- Recalling firm
- Merit Medical Systems, Inc.
- Product
- Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTDA35260EX, 260 cm (102").
- Status
- Terminated
- Initiated
- 2014-04-14
- Posted
- 2014-04-22
- Terminated
- 2014-07-17
- Reason
- 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
- 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
- 186
- Distribution
- Worldwide Distribution: USA Nationwide and China. No military/govt/VA consignees.
- Lot, serial or model codes
- Lot No. K556402, Expires 2016-10
- 510(k) numbers
- ["K120644"]
- PMA numbers
- not on file
- Product code
- DQX
- Firm FEI
- 1721504
- Firm city
- South Jordan
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28