Events

Recall of Device Recall TriActiv FX Embolic Protection System 7F

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
    37701
  • Event Risk Class
    Class 2
  • Event Number
    Z-0833-2007
  • Event Initiated Date
    2007-03-28
  • Event Date Posted
    2007-05-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-08-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51340
  • 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
    Embolic Protection System - Product Code FRO
  • Reason
    Insufficient wire sealing.
  • Action
    On 3/26/07, the recalling firm left voice mail message with all sales representatives instructing the sales representatives to contact all TriActiv FX accounts immediately. Recall notices were faxed on 3/28/07 to all accounts which received the product. Recall notices instructed the hospitals to quarantine all FX and to contact their sales representative to arrange for retrieval of the product if they had not already been contacted.

Device

Device Recall TriActiv FX Embolic Protection System 7F
  • Model / Serial
    Catalog numbers 60040-02 and 60040-03. Lot numbers 49709 exp 3/31/07, 51844 exp 5/31/07, 52822 exp 7/31/07, 53209 exp 5/31/07, 53252 exp 7/31/07, 54264 exp 7/31/07, 54276 exp 11/30/07, 49912 exp 3/30/07, 50952 exp 5/31/07, 51714 exp 7/31/07, 52488 exp 5/31/07, and 54248 exp 11/30/07.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA and Germany.
  • Product Description
    TriActiv FX Embolic Protection System 7F, Catalog numbers 60040-02 (has 190 cm guidewire) and 60040-03 (has 300 cm guidewire). The devices are comprised of four principal components including the ShieldWire Balloon Guidewire, the Shieldwire Inflator, the FX or LFX Catheter, and the AutoStream Flow Control.
  • Manufacturer
    Kensey Nash Corp

Manufacturer

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