Events

Recall of Merit Laureate Hydrophilic Guide Wire

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Merit Medical Systems, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68041
  • Event Risk Class
    Class 2
  • Event Number
    Z-1485-2014
  • Event Initiated Date
    2014-04-14
  • Event Date Posted
    2014-04-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-07-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126848
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    catheter guide wire - Product Code DQX
  • Reason
    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.
  • Action
    Customers were notified on 4/14/14 via certified letter with instructions to identify product, discontinue use, and return products.

Device

Merit Laureate Hydrophilic Guide Wire
  • Model / Serial
    Lot No. K556399, Expires 2016-10
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA Nationwide and China. No military/govt/VA consignees.
  • Product Description
    Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm), 260 cm (102").
  • Manufacturer
    Merit Medical Systems, Inc.

Manufacturer

Merit Medical Systems, Inc.
  • Manufacturer Address
    Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan UT 84095
  • Manufacturer Parent Company (2017)
    Merit Medical Systems Inc
  • Source
    USFDA