Z-0775-03

Guidant Multi-Link Vision Coronary Stent System Catalog Numbers: 30 different catalog numbers have been...

Name: Z-0775-03 Guidant Multi-Link Vision Coronary Stent System Catalog Numbers: 30 different catalog numbers have been...
Creator: Guidant Corporation ACS
Published: 2003-04-01
License: https://open.fda.gov/license/

Abbott Vascular / initiated 2003-04-01 / Terminated

FDA source

Guidant Corporation ACS began a recall of Guidant Multi-Link Vision Coronary Stent System Catalog Numbers: 30 different catalog numbers have been listed. The firm indicates that total numbers of... on 2003-04-01. The reason FDA records is "Complaints that the stents are being dislodged from the delivery system". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0775-03
Status: Terminated
Initiated: 2003-04-01
Posted: 2003-04-22
Terminated: 2004-06-23
Recalling firm: Abbott Vascular
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.
Reason for recall: Complaints that the stents are being dislodged from the delivery system.
FDA 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 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.
Product codes and lots: All lots are included in the action.

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)