Guidant Multi-Link Vision Coronary Stent System Catalog Numbers: 30 different catalog numbers have been listed. The firm
FDA device recall Z-0775-03 · posted 2003-04-22 · Terminated
Recall details
- Recalling firm
- Guidant Corporation ACS
- Reason for recall
- Complaints that the stents are being dislodged from the delivery system.
- Action taken
- 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
- Status
- Terminated
- Quantity affected
- 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,
- Date initiated
- 2003-04-01
- Date posted
- 2003-04-22
- Date terminated
- 2004-06-23
- Location
- Temecula, CA
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