Events

Recall of VASOVIEW 4 Endoscopic Vessel Harvesting System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by CTS, Inc. dba Guidant Cardiac Surgery.

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
    49550
  • Event Risk Class
    Class 2
  • Event Number
    Z-0476-2009
  • Event Initiated Date
    2008-09-09
  • Event Date Posted
    2008-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73793
  • 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
    Endoscope and accessories - Product Code GCJ
  • Reason
    Packaging unsealed: sterility of product may be compromised due to packaging issue. for further information, please contact the firm at 408-635-6874.
  • Action
    The firm issued a letter entitled "URGENT FIELD ACTION - IMMEDIATE ACTION REQUIRED *** VASOVIEW(TM) 4 Endoscopic Vessel Harvesting System (Kit Only)" via federal express to its consignees on September 9, 2008. The firm has asked its consignees to return the product. Follow-up calls were made to ensure recall effectiveness.

Device

VASOVIEW 4 Endoscopic Vessel Harvesting System
  • Model / Serial
    model numbers VH-10242, lot numbers 7100172 to 8081371, and VH-10243, lot numbers 7100171 to 8081271.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and country of Australia.
  • Product Description
    VASOVIEW 4 Endoscopic Vessel Harvesting System, with VASOVIEW Flexible Endoscopic Tools in the following configurations: VH-10242: Uniport plus dissection cannula, short port blunt tip trocar, flexible endoscopic scissors; and VH-10243: Uniport plus dissection cannula, short port blunt tip trocar, flexible endoscopic bisector.
  • Manufacturer
    CTS, Inc. dba Guidant Cardiac Surgery

Manufacturer

CTS, Inc. dba Guidant Cardiac Surgery
  • Manufacturer Address
    CTS, Inc. dba Guidant Cardiac Surgery, 170 Baytech Dr, San Jose CA 95134-2302
  • Source
    USFDA