FDA Medical Device Recalls (openFDA)
Numed Inc: CP STENT (Cheatham Platinum), a prescription device, composed of 90% platinum/10% iridium wire arranged in laser welded rows with a ''zig'' pattern. The number of zigs can be varied and will impact the strength of the stent as well as the eventual diameter and percent stent shortening. CP stents are sold either sterile or non-sterile, and sold in different lengths.
- Recall number
- Z-0983-03
- Recalling firm
- Numed Inc
- Product
- CP STENT (Cheatham Platinum), a prescription device, composed of 90% platinum/10% iridium wire arranged in laser welded rows with a ''zig'' pattern. The number of zigs can be varied and will impact the strength of the stent as well as the eventual diameter and percent stent shortening. CP stents are sold either sterile or non-sterile, and sold in different lengths.
- Status
- Terminated
- Initiated
- 2003-06-26
- Posted
- 2003-07-08
- Terminated
- 2004-06-09
- Reason
- Lacks a PMA or 510k.
- Root cause
- Other
- Action
- Recall Letters were sent to doctors dated 6/26/03 requesting return of the stents.
- Quantity
- 169 units
- Distribution
- The stents were shipped to individual doctors in 29 hospitals in the U.S.
- Lot, serial or model codes
- All lots produced.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MAF
- Firm FEI
- 1318694
- Firm city
- Hopkinton
- Firm state
- NY
- 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