Events

Recall of Device Recall Precision Bipolar Device ClearGlide EVH

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Datascope 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
    38005
  • Event Risk Class
    Class 2
  • Event Number
    Z-1156-2007
  • Event Initiated Date
    2007-05-07
  • Event Date Posted
    2007-08-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52708
  • 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
    endoscopic vessel harvesting system - Product Code GEI
  • Reason
    Datascope has experienced a higher than usual number of reports involving the precision bipolar device. reports include the locking or sticking of the buttons of the device which operate the jaws, particularly when a side load is placed on the shaft of the device.
  • Action
    Letters were sent to all hospitals, (contact: Hospital Administrators) the week of May 7, 2007 (certified mail, Return Receipt requested) with Urgent Medical Device Field Correction. The letter requests that all potential users of the devices at the institution be mdae aware of the situation. The letter instructs clinicians what to do if they experience problems with locking buttons of the Precision Device and also if the device is clamped closed on a vein branch and cannot be opened. Institutions are also requested to sign and return a postal card acknowledging receipt of the Field Correct notification and Datascope provides telephone numbers for customer service.

Device

Device Recall Precision Bipolar Device ClearGlide EVH
  • Model / Serial
    Part number KTV 15 Lot numbers: 12499, Exp. 4/21/09; 12500, Exp. 4/22/09; 12501, Exp. 4/27/09; 12504, Exp. 5/04/09 and 12505, Exp. 5/13/09.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Belgium, the Netherlands, and Germany.
  • Product Description
    Precision Bipolar Device || ClearGlide EVH Small (endoscopic vessel harvesting system) || The kit included three Precision BiPolar Devices, an Optical Vessel Dissector, a Small Ultra Retractor and a Vessel Dissector. || Datascope Cardiac Assist || Sterile R || Manufactured for: || Datascope Cardiac Assist || 15 Law Drive || Fairfield, NJ 07004
  • Manufacturer
    Datascope Corporation

Manufacturer

Datascope Corporation
  • Manufacturer Address
    Datascope Corporation, 15 Law Dr, Fairfield NJ 07004-0011
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA