Events

Recall of Device Recall Boston Scientific Wiseguide Guide Catheter

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
    35515
  • Event Risk Class
    Class 2
  • Event Number
    Z-1102-06
  • Event Initiated Date
    2006-05-22
  • Event Date Posted
    2006-06-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46297
  • 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
    Guide Catheter - Product Code DQY
  • Reason
    Gaps were identified between polymer segments on the 7f wiseguide guide catheter in which the ptfe was not properly laminated to the braid of the catheter. this delamination of the ptfe from the braid could compromise the device delivery.
  • Action
    Affected customers were mailed an Urgent Medical Device Recall or Correction - Immediate Action Required letter, dated 05/22/2006. The letter describes the issue, states to immediately discontinue use of and segregate recalled product, provides instructions to ship product back to Boston Scientific and asks for the Reply Verification Tracking Form to be faxed to Boston Scientific in acknowledgement.

Device

Device Recall Boston Scientific Wiseguide Guide Catheter
  • Model / Serial
    Catalog number 19500-448, Lot # 655713; Catalog number 19500-498, Lot # 655721; Catalog number 19500-08, Lot # 657310; Catalog number 19500-09, Lot # 657311; Catalog number 19500-132, Lot # 655680; Catalog number 19500-27, Lot # 655695;
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide- States of AZ, CA, CO, FL, HI, KS, MI, NV, OK, TX, VA.
  • Product Description
    Boston Scientific Wiseguide Guide Catheter 7F, .076 '', Femoral Approach, Manufactured for Boston Scientific Scimed, Inc., One Scimed Place, Maple Grove, MN USA 55311. Nonpyrogenic.
  • Manufacturer
    Boston Scientific

Manufacturer

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