Z-0983-03

CP STENT (Cheatham Platinum), a prescription device, composed of 90% platinum/10% iridium wire arranged in...

Name: Z-0983-03 CP STENT (Cheatham Platinum), a prescription device, composed of 90% platinum/10% iridium wire arranged in...
Creator: Numed Inc
Published: 2003-06-26
License: https://open.fda.gov/license/

Numed Inc / initiated 2003-06-26 / Terminated

FDA source

Numed Inc began a recall of 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... on 2003-06-26. The reason FDA records is "Lacks a PMA or 510k". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0983-03
Status: Terminated
Initiated: 2003-06-26
Posted: 2003-07-08
Terminated: 2004-06-09
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.
Product code: MAF Stent, Coronary
Reason for recall: Lacks a PMA or 510k.
FDA root cause: Other
Action: Recall Letters were sent to doctors dated 6/26/03 requesting return of the stents.
Quantity in commerce: 169 units
Distribution: The stents were shipped to individual doctors in 29 hospitals in the U.S.
Product codes and lots: All lots produced.

Product code MAF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)