Events

Recall of Device Recall QuickCross Support Catheters

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
    45949
  • Event Risk Class
    Class 2
  • Event Number
    Z-0698-2008
  • Event Initiated Date
    2007-12-10
  • Event Date Posted
    2008-02-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-02-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67042
  • 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
    Catheter - Product Code DQY
  • Reason
    Mislabeling: catheters were placed into mis-labeled inner pouches as ref number 518-037, 135 cm--the exterior box labeling is correct as 90 cm.
  • Action
    Consignees were notified by Dear Healthcare provider letter on 12/10/2007 and were told that a sales rep would remove and replace all affected catheters.

Device

Device Recall QuickCross Support Catheters
  • Model / Serial
    Lot Number: 0709158
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide including states of FL, IL, IN, MO, NC, NY, TX, and UT.
  • Product Description
    Spectranetics Quick-Cross Support Catheters, .035in x 90cm, REF#: 518-036, Sterile, Manufactured by: Spectranetics, Colorado Springs, Colorado 80907.
  • 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