Z-1075-03

Guidant Multi-Link Zeta Coronary Stent System

Name: Z-1075-03 Guidant Multi-Link Zeta Coronary Stent System
Creator: Guidant Corporation ACS
Published: 2003-07-15
License: https://open.fda.gov/license/

Abbott Vascular / initiated 2003-07-15 / Terminated / root cause: packaging

FDA source

Guidant Corporation ACS began a recall of Guidant Multi-Link Zeta Coronary Stent System on 2003-07-15. The reason FDA records is "Potential loss of package sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1075-03
Status: Terminated
Initiated: 2003-07-15
Posted: 2003-08-01
Terminated: 2004-04-14
Recalling firm: Abbott Vascular
Product: Guidant Multi-Link Zeta Coronary Stent System
Reason for recall: Potential loss of package sterility.
Root cause tag: packaging
FDA root cause: Other
Action: Firm personnel in China have inspected all Chinese consignee end user inventories. Any units found to be defective have been removed and are currently in Guidant control.
Quantity in commerce: Not stated
Distribution: China
Product codes and lots: 3050632 3060432 3060251 3051952 3052251 3060331 3051231 3051951 3052752 3052031 3051931 3050651 3052752 3060531 3060451 3050751 3052251 3051951 3050931 3050632 3052032 3060251 3051531 3053051 3051634 3051632 3053051 3051531 3052952 3051552 3050931 3052852 3060431 3060432 3050751 3052131 3051532 3052031 3051631 3050251 3043051 3050931 3051531 3051451 3052851 3051551 3051531 3041031

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)