Recall Z-0983-03 ยท MAF Stent, Coronary
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.
| Date | Jul 8, 2003 (initiated Jun 26, 2003) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.