Events

Recall of Device Recall CP (Cheatham Platinum)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Numed Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    26556
  • Event Risk Class
    Class 2
  • Event Number
    Z-0983-03
  • Event Initiated Date
    2003-06-26
  • Event Date Posted
    2003-07-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-06-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27887
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Stent, Coronary - Product Code MAF
  • Reason
    Lacks a pma or 510k.
  • Action
    Recall Letters were sent to doctors dated 6/26/03 requesting return of the stents.

Device

Device Recall CP (Cheatham Platinum)
  • Model / Serial
    All lots produced.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    The stents were shipped to individual doctors in 29 hospitals in the U.S.
  • Product Description
    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.
  • Manufacturer
    Numed Inc

Manufacturer

Numed Inc
  • Manufacturer Address
    Numed Inc, 2880 Main Street/Rt 11b, Hopkinton NY 12965
  • Source
    USFDA