Events

Recall of Device Recall Cordis Aquatrack

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
    53953
  • Event Risk Class
    Class 2
  • Event Number
    Z-0623-2010
  • Event Initiated Date
    2009-08-25
  • Event Date Posted
    2010-01-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-08-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86930
  • 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
    guidewire for use in angiographic procedures - Product Code DQX
  • Reason
    Some of the guidewires in these two lots have a straight tip (incorrect) rather than an angled tip (correct configuration for that catalog number).
  • Action
    Recall for Lot 80000521 was initiated on August 25, 2009 with Cordis Medical Device Recall letters being mailed for delivery on August 25, 2009. Response form was also provided to obtain product disposition. Recall for Lot 80000584 was initiated on October 19, 2009 with Cordis Medical Device Recall letters being mailed for delivery on October 20, 2009. Response form was also provided to obtain product disposition.

Device

Device Recall Cordis Aquatrack
  • Model / Serial
    Lots 80000521 and 80000584
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution.
  • Product Description
    Cordis Aquatrack Hydrophilic Nitinol Guidewire, for use in angiographic procedures, REF C3526-SSA, Guidewire Diameter .035" Tip Length Flexible 3 cm, Sterile. || Contents 5 Hydrophilic guidewires and torquing devices.
  • 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