Events

Recall of Device Recall Transend EX

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
    38310
  • Event Risk Class
    Class 3
  • Event Number
    Z-0122-2008
  • Event Initiated Date
    2007-06-14
  • Event Date Posted
    2007-12-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53385
  • 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
    Intravascular Catheter Guidewire - Product Code DQX
  • Reason
    Mislabeling: product is labeled with the wrong expiration date: 2009-12. the correct expiration date is 2008-12.
  • Action
    Boston Scientific issued a letter to all consignees by mail on June 14, 2007, titled Urgent Medical Device Recall or Correction - Immediate Action Required. The letter describes that the expiration date is incorrect. Discontinue use of the product, segregate it, complete the Reply Verification Tracking Form and fax it to Boston Scientific. Call 888-272-1001 to obtain a Returned Goods Authorization (RGA) number.

Device

Device Recall Transend EX
  • Model / Serial
    Lot Number: 9264947.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Boston Scientific Target, Transend EX Soft Tip Guide Wire, .014in /205cm, UPN: M001468060, Catalog Number: 46-806, || Boston Scientific Target, Fremont, CA 94538
  • Manufacturer
    Boston Scientific Target

Manufacturer

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