Events

Recall of Device Recall Guidant MultiLink RX Vision

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
    39147
  • Event Risk Class
    Class 2
  • Event Number
    Z-1211-2007
  • Event Initiated Date
    2007-07-16
  • Event Date Posted
    2007-08-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=54962
  • 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
    coronary stent - Product Code MAF
  • Reason
    The affected single lot did not meet an internal specification. one unit failed the test criteria for stent dislodgment testing.
  • Action
    The firm initiated the recall on 07/16/2007 by sending recall letters with attached Customer Reply form via FedEx to each direct account that received the recalled product. Customers were informed of the issue and given instructions to work with their local account representative to review their inventory, remove the recalled product, complete the Customer Reply form and return the recalled product to Abbott Vascular.

Device

Device Recall Guidant MultiLink RX Vision

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