Events

Recall of Device Recall Matrix2

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Boston Scientific Target.

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
    37384
  • Event Risk Class
    Class 2
  • Event Number
    Z-0668-2007
  • Event Initiated Date
    2007-02-07
  • Event Date Posted
    2007-03-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-11-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50456
  • 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
    vascular embolization device - Product Code HCG
  • Reason
    The product may be missing the temperature indicator label on the inner pouch.
  • Action
    The firm initiated the recall on 02/07/2007, and initially notified consignees via letter.

Device

Device Recall Matrix2
  • Model / Serial
    Batch Numbers: 8941830 and 8852539
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide including USA, Argentina, Australia, Brazil, Czech Republic, Germany, Spain, Finland, France, Great Britain, Greece, Ireland, Netherlands, and New Zealand.
  • Product Description
    Matrix2 Detachable Coils, vascular embolization device. || Catalog Number: 497204SR, UPN: M003497204SR0, || Catalog Number: 494203, UPN: M0034942030, Distributed and Manufactured by Boston Scientific Corporation, Neurovascular Division, Fremont, CA
  • Manufacturer
    Boston Scientific Target

Manufacturer

Boston Scientific Target
  • Manufacturer Address
    Boston Scientific Target, 47900 Bayside Pkwy, Fremont CA 94538-6515
  • Source
    USFDA