Events

Recall of Device Recall Cypher sterile stent

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

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
    30903
  • Event Risk Class
    Class 2
  • Event Number
    Z-0437-05
  • Event Initiated Date
    2005-01-12
  • Event Date Posted
    2005-01-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-02-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36787
  • 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
    Coronary Drug-Eluting Stent - Product Code NIQ
  • Reason
    Six of 370 stents released to market had a slightly below the required polymeric coating weight. all other specification were met.
  • Action
    A withdrawal letter is in the process of being hand-delivered to accounts that received this lot, by a Cordis sales representative. Any remaining units from this lot are being removed, and returned to Cordis. The returned units will be scrapped. An Acknowledgement Form is being signed indicating that the account was informed, and documenting whether there is any remaining product from this lot. The withdrawal action was initiated January 12, 2005.

Device

Device Recall Cypher sterile stent
  • Model / Serial
    Lot no. X1004212
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Distributed throughout the United States.
  • Product Description
    Polymeric coated stent. Cypher BX Velocity Cardio Sirolimus Stents.
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation
  • Manufacturer Address
    Cordis Corporation, 14201 NW 60th Ave, Miami Lakes FL 33014-2802
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    USFDA