FDA Medical Device Recalls (openFDA)
Guidant Corporation ACS: Guidant Multi-Link Zeta Coronary Stent System
- Recall number
- Z-1075-03
- Recalling firm
- Guidant Corporation ACS
- Product
- Guidant Multi-Link Zeta Coronary Stent System
- Status
- Terminated
- Initiated
- 2003-07-15
- Posted
- 2003-08-01
- Terminated
- 2004-04-14
- Reason
- Potential loss of package sterility.
- 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
- Not stated
- Distribution
- China
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- ["P970020S042"]
- 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