Events

Recall of Device Recall QuickCat

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Spectranetics 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
    56115
  • Event Risk Class
    Class 2
  • Event Number
    Z-2190-2010
  • Event Initiated Date
    2010-07-01
  • Event Date Posted
    2010-08-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-08-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92696
  • 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
    Extraction catheter - Product Code DXE
  • Reason
    Guidewire lumen may be occluded, preventing guidewire insertion into the catheter.
  • Action
    Consignees were notified by letter on Jul 1, 2010, and told to not use affected lots and to contact Spectranetics to arrange a product exchange. More information is available at 800-231-0978.

Device

Device Recall QuickCat
  • Model / Serial
    Lot numbers FQT09K07A through FQT10F09A.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA, Argentina, Austria, Belgium, Brazil, Chile, Czech Republic, Finland, France, French Polynesia, Germany, Hungary, Israel, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, and Venezuela.
  • Product Description
    Spectranetics Corporation, QuickCat Extraction Catheter, REF 60090-01, Sterile R, Working Length 145cm, for embolus and thrombus removal from arterial vessels.
  • Manufacturer
    Spectranetics Corporation

Manufacturer

Spectranetics Corporation
  • Manufacturer Address
    Spectranetics Corporation, 96 Talamine Ct, Colorado Springs CO 80907-5159
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA