Events

Recall of Device Recall Boston Scientific/Target ascular

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Boston Scientific 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
    26601
  • Event Risk Class
    Class 2
  • Event Number
    Z-1034-03
  • Event Initiated Date
    2003-06-23
  • Event Date Posted
    2003-07-19
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27968
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
  • Reason
    Product 's outer box label may not match pouch label: a 4mm x 30 mm coil may be labeled as a 9 mm x 60 mm or vice versa.
  • Action
    Boston Scientific notified sales representatives on 6/23/03 in foreign distribution area to remove product from inventory and contact hospital to retrieve and return.

Device

Device Recall Boston Scientific/Target ascular
  • Model / Serial
    Lot Number: 5472234
  • Product Classification
    Cardiovascular Devices
  • Distribution
    Japan, Italy, France, Turkey, Israel, Finland
  • Product Description
    Fibered Platinum Coil, 0.035 Type, || 9 mm x 60 mm || Catalog no. 372906
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, 1 Boston Scientific Place, Natick MA 01760
  • Source
    USFDA