FDA Medical Device Recalls (openFDA)
Guidant Corporation ACS: 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.
- Recall number
- Z-0775-03
- Recalling firm
- Guidant Corporation ACS
- 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.
- Status
- Terminated
- Initiated
- 2003-04-01
- Posted
- 2003-04-22
- Terminated
- 2004-06-23
- Reason
- Complaints that the stents are being dislodged from the delivery system.
- Root 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
- 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.
- Lot, serial or model codes
- All lots are included in the action.
- 510(k) numbers
- not on file
- PMA numbers
- ["P020047"]
- Product code
- not on file
- Firm FEI
- 2024168
- Firm city
- Temecula
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28