Events

Recall of Device Recall TriActiv System Procedure Kit 190 cm

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
    35680
  • Event Risk Class
    Class 2
  • Event Number
    Z-1219-06
  • Event Initiated Date
    2006-05-24
  • Event Date Posted
    2006-07-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-07-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46607
  • 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
    Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection - Product Code NFA
  • Reason
    Volume control knob not able to go up to larger diameters.
  • Action
    A letter was issued to the sales representative that have customers which received affected product, 5/24/2006. Sales representatives visited their sites within 3 days to determine if the affected product was still in inventory. If the product was still in inventory the sales representative provided the trained TriActiv System user(s) a Technical Bulletin that instructed the users how to correct the knob position.

Device

Device Recall TriActiv System Procedure Kit 190 cm
  • Model / Serial
    Lot number 47303 exp 9/30/06
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. The products are shipped to hospitals in AL, DE, Fl, IL, IN, MI, PA, SC, TN and TX.
  • Product Description
    TriActiv System Procedure Kit. Balloon Protected Flush Extraction System 190 cm (for embolism protection). The kit includes AutoStream Flow Control, Flush Kit, ShieldWire (temporary occlusion balloon guidewire), and Balloon Inflation Syringe). The system is used with a standard 7F 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