FDA Medical Device Recalls (openFDA)
Cordis Corporation: Polymeric coated stent. Cypher BX Velocity Cardio Sirolimus Stents.
- Recall number
- Z-0437-05
- Recalling firm
- Cordis Corporation
- Product
- Polymeric coated stent. Cypher BX Velocity Cardio Sirolimus Stents.
- Status
- Terminated
- Initiated
- 2005-01-12
- Posted
- 2005-01-26
- Terminated
- 2005-02-09
- Reason
- Six of 370 stents released to market had a slightly below the required polymeric coating weight. All other specification were met.
- Root cause
- Other
- Action
- A withdrawal letter is in the process of being hand-delivered to accounts that received this lot, by a Cordis sales representative. Any remaining units from this lot are being removed, and returned to Cordis. The returned units will be scrapped. An Acknowledgement Form is being signed indicating that the account was informed, and documenting whether there is any remaining product from this lot. The withdrawal action was initiated January 12, 2005.
- Quantity
- 300
- Distribution
- Distributed throughout the United States.
- Lot, serial or model codes
- Lot no. X1004212
- 510(k) numbers
- not on file
- PMA numbers
- ["P020026"]
- Product code
- NIQ
- Firm FEI
- 1016427
- Firm city
- Miami Lakes
- Firm state
- FL
- 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