Events

Recall of Device Recall ThromCat

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

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
    37393
  • Event Risk Class
    Class 2
  • Event Number
    Z-0597-2007
  • Event Initiated Date
    2007-02-07
  • Event Date Posted
    2007-03-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-06-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50469
  • 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
    Thrombectomy Catheter - Product Code MCW
  • Reason
    Face seal may wear excessively and cause particulate matter.
  • Action
    On 2/7/07, a voice mail message was sent to all KNC Sales Representatives instructing them to contact affected accounts immediately. On 2/9/07, recall notices were faxed to all affected accounts that had affected product. The recall notices instructed hospitals to quarantine the affected lots and to contact their KNC Sales Representative to arrange for retrieval of the product.

Device

Device Recall ThromCat
  • Model / Serial
    Lot number 54877 exp December 2007, Lot number 55318 exp January 2008, Lot number 55218 exp January 2008, and Lot number 54821 exp December 2007
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    ThromCat Thrombectomy Catheter System. 7F 2.5 -7.0 mm 150 cm. Catalogue number 63000-01. It is a single-use, disposable device that is used to perform percutaneous maceration and removal of thrombus and restoration of blood flow.
  • Manufacturer
    Kensey Nash Corp

Manufacturer

Kensey Nash Corp
  • Manufacturer Address
    Kensey Nash Corp, 735 Pennsylvania Dr, Exton PA 19341-1130
  • Source
    USFDA