FDA Medical Device Recalls (openFDA)
Guidant Corporation ACS: MULTI-LINK Pixel Coronary Stent System Size: 2.0 x 13 mm OTW Part Number: 1007830-13
- Recall number
- Z-0862-03
- Recalling firm
- Guidant Corporation ACS
- Product
- MULTI-LINK Pixel Coronary Stent System Size: 2.0 x 13 mm OTW Part Number: 1007830-13
- Status
- Terminated
- Initiated
- 2003-05-07
- Posted
- 2003-05-22
- Terminated
- 2004-12-01
- Reason
- Sterility compromised.
- Root cause
- Other
- Action
- The firm initially is notifying by letter dated May 6, 2003 and will plan visit follow-ups to collect quarantined product.
- Quantity
- 40
- Distribution
- NATIONWIDE
- Lot, serial or model codes
- Lot 3021951
- 510(k) numbers
- not on file
- PMA numbers
- ["P970020S030"]
- Product code
- MAF
- 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