Events

Recall of Device Recall Boston Scientific IQ Guide Marker Wire

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

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
    35549
  • Event Risk Class
    Class 2
  • Event Number
    Z-1217-06
  • Event Initiated Date
    2006-05-30
  • Event Date Posted
    2006-07-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-06-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46386
  • 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
    Wire, Guide, Catheter - Product Code DQX
  • Reason
    Boston scientific discovered through an internal inspection process that the ptfe (polytetrafluoroethylene) coating is not consistently adhering to the transition area of the distal end of the guide wires which may cause ptfe to flake off.
  • Action
    On May 30, 2006, Boston Scientific notified customers of the IQ Guide Wire manufactured from February 3, 2006, through March 15, 2006. BSC requested a reply whether or not they still have product in their institution. Replacements will be issued for returned product. UPDATE: A second recall notification was sent to affected customers 07/07/06. This second notification included Inner Pouch Number (UPN) and Inner Pouch Lot/Batch #.

Device

Device Recall Boston Scientific IQ Guide Marker Wire
  • Model / Serial
    Catalog No. 38951-010, Box Lot No. AND Inner-Pouch Lot/Batch #: 8423358/8387074, 8453483/8432572, 8464007/8432571, 8510637/8404526.  Catalog No. 38951-012, Box Lot No. AND Inner-Pouch Lot/Batch #: 8423360/8387074, 84640088432571, 8510638/8404526.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide (AR, AZ, FL, GA, IA, ID, IL, IN, KY, LA, MA, MI, MN, MO, NC, NH, NJ, NM, NV, OH, OK, PA, TN, TX, UT, VA, WI, WV) and Puerto Rico. Chile, Germany, Taiwan.
  • Product Description
    Boston Scientific IQ Guide Marker Wire. Catalog No. 38951-010, 185 cm, Straight Tip, Single Pack. Catalog No. 38951-012, 185 cm, Straight Tip, 5 pack. Sterile EO. Manufactured for: Boston Scientific Corporation, One Boston Scientific Place, Natick, MN 01760 USA. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped ''J'' tip.
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Manufacturer Address
    Boston Scientific, 1 Scimed Pl, Maple Grove MN 55311-1565
  • Source
    USFDA