Events

Recall of Device Recall VirtoSaph Plus Endoscopic Vessel Harvesting System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Terumo Cardiovascular Systems Corporation.

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
    59189
  • Event Risk Class
    Class 2
  • Event Number
    Z-2854-2011
  • Event Initiated Date
    2011-06-10
  • Event Date Posted
    2011-07-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101568
  • 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
    General and plastic surgery laparascope - Product Code GCJ
  • Reason
    Terumo cardiovascular systems received four (4) complaints from a single customer about tunnel breathing/inadequate insufflation with the virtuosaph plus endoscopic vessel harvesting system during cases in a limited production launch situation. teumo's investigation identified issues with the devices's capability to maintain pressure within the tunnel.
  • Action
    Terumo Cardiovascular Systems contacted the one customer to this device on June 10, 2010 by telephone. There was one consignee. The firm contacted this one consignee by phone on 6/10/2010. There were 2 contacts at this one consignee. The recalling firm contacted both of the contacts on 6/10/2010. The consignee was asked to dispose of remaking inventory of devices. The consignee said had disposed of the product. For information on this recall call (734) 741-6173

Device

Device Recall VirtoSaph Plus Endoscopic Vessel Harvesting System
  • Model / Serial
    Catalog #: VSP550 Lots: 0XK, 0YK, 09K.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide (USA) Distribution including the state of New York.
  • Product Description
    VirtuoSaph Plus Endoscopic Vessel Harvesting System , REF VSP550, Sterile, Terumo Cardiovascular System || Indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels and dissection of blood vessels of the extremities. Extremity procedures include tissue dissection and/or vessel harvesting along the saphenous vein for coronary artery bypass grafting and peripheral artery bypass grafting.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Manufacturer Address
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA