Events

Recall of Micrus

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Micrus Endovascular Corporation.

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
    36344
  • Event Risk Class
    Class 2
  • Event Number
    Z-1542-06
  • Event Initiated Date
    2006-09-08
  • Event Date Posted
    2006-09-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-06-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48452
  • 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
    Guide wire soft tip - Product Code DQX
  • Reason
    During use, the introducer may cause the guide wire''s coating to strip off and may result in loose material which could break free and enter the blood stream.
  • Action
    On 9/8/06 the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall.

Device

Micrus
  • Model / Serial
    All lots including F22741, F22742, F22743, F22744, F22745, F22746, F22747, F22749.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide
  • Product Description
    Micrus brand WATUSI Guidewire 0.014'' - Soft Tip, Catalog Number; WST 140205-00; || Distributed by Micrus Endovascular Corporation. San Jose, CA
  • Manufacturer
    Micrus Endovascular Corporation

Manufacturer

Micrus Endovascular Corporation
  • Manufacturer Address
    Micrus Endovascular Corporation, 821 Fox Lane, San Jose CA 95131
  • Source
    USFDA