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.
FDA Recall Z-0775-03 · Posted 2003-04-22
Recalling FirmGuidant Corporation ACS
Recall StatusTerminated
Date Initiated2003-04-01
Date Terminated2004-06-23
Product QuantityEstimated 7 to 9 thousand units
Reason for Recall
Complaints that the stents are being dislodged from the delivery system.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.