Events

Recall of Device Recall Boston Scientific Guider Softip XF Guiding Catheter

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
    38445
  • Event Risk Class
    Class 3
  • Event Number
    Z-0259-2008
  • Event Initiated Date
    2007-07-11
  • Event Date Posted
    2007-11-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53781
  • 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
    Guiding Catheter - Product Code DQY
  • Reason
    Mislabeling: catheters were found to be mislabeled (90 cm labeled devices actually contains 100 cm length catheter).
  • Action
    Firm notified consignees by Urgent Medical Device Recall Letter dated 11 Jul 07 requesting return of product.

Device

Device Recall Boston Scientific Guider Softip XF Guiding Catheter
  • Model / Serial
    LOT 9311885, Catalogue #10042, Material #H965100420, Expires 10-JAN-2010
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA, EU, Japan, South Korea, Mexico, Colombia, and Hungary.
  • Product Description
    Boston Scientific 6F Guider Softip XF Guiding Catheter, 6 French, 40 degree angle, 90cm usable length, Material Number (UPN) H965100420, Catalog Number : 10042, Made in USA: 5905 Nathan Lane, Plymouth, MN 55442 USA
  • Manufacturer
    Boston Scientific Target

Manufacturer

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