Events

Recall of TriActiv ProGuard Embolic Protection System

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
    35280
  • Event Risk Class
    Class 2
  • Event Number
    Z-1305-06
  • Event Initiated Date
    2006-04-06
  • Event Date Posted
    2006-07-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-08-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45714
  • 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 NFA
  • Reason
    Alarm activiation-a priming issue involving the flow control unit due to a software problem has caused false postive extraction line block (elb) alarming. use of this product may result in a health hazard resulting from early termination of the flush and extraction procedure after stenting.
  • Action
    The recalling firm issued a draft recall letter to their European distributor who translated the letter for their customers.

Device

TriActiv ProGuard Embolic Protection System
  • Model / Serial
    Part number 61000-01. Lot number 48275 exp 1/07
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to hospitals in Germany and Italy.
  • Product Description
    TriActiv ProGuard Embolic Protection System, Part number 61000-01. The product is shipped as a procedure kit. It is used with a standard 6F guide catheter using the standard femoral approach.
  • Manufacturer
    Kensey Nash Corp

Manufacturer

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