FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc.: Merit Laureate Hydrophylic Guide Wire, Angled, Made In Ireland, CAT No: LWSTDA35260EX, 260cm, Sterile EO, Merit Medical Systems, Inc., South Jordan, UT 84095. Intended to facilitate the placement of devices during diagnostic and interventional procedures.
- Recall number
- Z-2104-2010
- Recalling firm
- Merit Medical Systems, Inc.
- Product
- Merit Laureate Hydrophylic Guide Wire, Angled, Made In Ireland, CAT No: LWSTDA35260EX, 260cm, Sterile EO, Merit Medical Systems, Inc., South Jordan, UT 84095. Intended to facilitate the placement of devices during diagnostic and interventional procedures.
- Status
- Terminated
- Initiated
- 2010-06-28
- Posted
- not on file
- Terminated
- 2010-10-19
- Reason
- Guidewires have decreased lubricity at the proximal end, inhibiting proper operation.
- 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
- 199 units
- Distribution
- Nationwide distribution: CA, CO, FL, GA, IL, IN, KS, MA, MD, MI, MN, NC, NH, NJ, NY, PA, and SD.
- Lot, serial or model codes
- Lot Number K130761 (3 year expiry), P116003 (1 year expiry)
- 510(k) numbers
- ["K092303"]
- 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