Class 2 Device Recall

• Date Initiated by Firm: April 01, 2003
• Date Posted: April 22, 2003
• Recall Status: Terminated 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/ Manufacturer: Guidant Corporation ACS; 26531 Ynez Road; Temecula CA 92591-4628
• For Additional Information Contact: James C. McMahon, PhD; 909-914-2298
• Manufacturer Reason for Recall: Complaints that the stents are being dislodged from the delivery system.
• FDA Determined Cause: Other
• 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.