Events

Recall of MULTI-LINK Pixel Coronary Stent System || Size: 2.0 x 13 mm OTW || Part Number: 1007830-13

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

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
    26264
  • Event Risk Class
    Class 2
  • Event Number
    Z-0862-03
  • Event Initiated Date
    2003-05-07
  • Event Date Posted
    2003-05-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-12-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27400
  • 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
    Stent, Coronary - Product Code MAF
  • Reason
    Sterility compromised.
  • Action
    The firm initially is notifying by letter dated May 6, 2003 and will plan visit follow-ups to collect quarantined product.

Device

MULTI-LINK Pixel Coronary Stent System || Size: 2.0 x 13 mm OTW || Part Number: 1007830-13
  • Model / Serial
    Lot 3021951
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    NATIONWIDE
  • Product Description
    MULTI-LINK Pixel Coronary Stent System || Size: 2.0 x 13 mm OTW || Part Number: 1007830-13
  • Manufacturer
    Guidant Corporation ACS

Manufacturer

Guidant Corporation ACS
  • Manufacturer Address
    Guidant Corporation ACS, 26531 Ynez Road, Temecula CA 92591-4628
  • Source
    USFDA