Events

Recall of Device Recall Abbott Vascular 6F Viking Guiding Catheter, Shape BPL

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Vascular-Cardiac Therapies dba Guidant 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
    47361
  • Event Risk Class
    Class 3
  • Event Number
    Z-1634-2008
  • Event Initiated Date
    2008-03-17
  • Event Date Posted
    2008-08-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69287
  • 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
    Catheter - Product Code DQY
  • Reason
    Mislabeling: the part number on the product label packaging may not match the product.
  • Action
    Consignees were notified via an Urgent Device Recall letter dated and hand delivered starting 3/18/08. The letter requests users to remove and quarantine the affected lots, which will be picked up and replaced by the recalling firm. Users were also requested to return the enclosed Efficiency Check Reconciliation Form. Abbott Vascular will exchange all returned devices. For additional information contact 1-800-227-9902.

Device

Device Recall Abbott Vascular 6F Viking Guiding Catheter, Shape BPL
  • Model / Serial
    Lot Number: 8011791
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    6F Viking Guiding Catheter, Percutaneous catheter Shape BP-L, Part Number: 1001970-06, Abbott Vascular, Santa Clara, CA 95054. || Intended to provide a pathway through which therapeutic and diagnostic devices are introduced.
  • Manufacturer
    Abbott Vascular-Cardiac Therapies dba Guidant Corporation

Manufacturer

Abbott Vascular-Cardiac Therapies dba Guidant Corporation
  • Manufacturer Address
    Abbott Vascular-Cardiac Therapies dba Guidant Corporation, 26531 Ynez Rd, Temecula CA 92591-4630
  • Source
    USFDA