Events

Recall of Device Recall CLEARGLIDE PRECISION BIPOLAR DEVICE

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sorin Group USA, Inc..

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
    54000
  • Event Risk Class
    Class 2
  • Event Number
    Z-0629-2010
  • Event Initiated Date
    2009-11-25
  • Event Date Posted
    2010-01-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87085
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Reason
    Vessel clamping device may break during use.
  • Action
    Consignees were notified by "Urgent Field Safety Notice" dated November 24, 2009 with instructions to examine the device before, during and after use. Customers were instructed to not use the device, if it is damaged. Customers were also instructed to contact the Sorin Group Customer Service at 1-800-650-2623 to arrange shipment of replacement product and requested to complete and return the response form. Direct questions to the Sorin Group Customer Service at 1-800-650-2623.

Device

Device Recall CLEARGLIDE PRECISION BIPOLAR DEVICE
  • Model / Serial
    Lot Numbers: 0916600195, 0925100114, 0922900040, 0927200176, 0929400009.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Australia, Canada and Italy.
  • Product Description
    Sorin / Clearglide EVH Long View with Scissor, REF KTV23, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004. || The device is indicated for endoscopic and open tissue dissection, bipolar coagulation, and transaction of blood vessels. Device is a single patient use bipolar instrument that uses a bipolar electrosurgical generator and is used predominately for endoscopic harvesting of the saphenous vein from the leg for coronary bypass surgery.
  • Manufacturer
    Sorin Group USA, Inc.

Manufacturer

Sorin Group USA, Inc.
  • Manufacturer Address
    Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Source
    USFDA