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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm April 01, 2003
Date Posted April 22, 2003
Recall Status1 Terminated 3 on June 23, 2004
Recall Number Z-0775-03
Recall Event ID 25945
PMA Number P020047 
Product Guidant Multi-Link Vision Coronary Stent System

Catalog Numbers: 30 different catalog numbers have been listed.

The firm indicates that total numbers of devices subject to this removal are being defined.
Code Information All lots are included in the action.
Recalling Firm/
Guidant Corporation ACS
26531 Ynez Road
Temecula CA 92591-4628
For Additional Information Contact James C. McMahon, PhD
Manufacturer Reason
for Recall
Complaints that the stents are being dislodged from the delivery system.
FDA Determined
Cause 2
Action Information as an Advisory Notice was sent by facsimile to the Competent Authorities and to distributors on April 1 2003. Recall letters will be delivered by hand in most instances.
Quantity in Commerce Estimated 7 to 9 thousand units
Distribution No USA distribution, only to the countries of Australia, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Italy, Lebanon, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, Tunisia, United Kingdom.

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.