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Terminated

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.

FDA Recall Z-0983-03 · Posted 2003-07-08

Recalling FirmNumed Inc
Recall StatusTerminated
Product CodeMAF
Date Initiated2003-06-26
Date Terminated2004-06-09
Product Quantity169 units

Reason for Recall

Lacks a PMA or 510k.

Firm Action

Recall Letters were sent to doctors dated 6/26/03 requesting return of the stents.

Root Cause

Other

Distribution Pattern

The stents were shipped to individual doctors in 29 hospitals in the U.S.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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