Z-1156-2007

Precision Bipolar Device ClearGlide EVH Small (endoscopic vessel harvesting system) The kit included three...

Name: Z-1156-2007 Precision Bipolar Device ClearGlide EVH Small (endoscopic vessel harvesting system) The kit included three...
Creator: Datascope Corporation
Published: 2007-05-07
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2007-05-07 / Terminated

FDA source

Datascope Corporation began a recall of Precision Bipolar Device ClearGlide EVH Small (endoscopic vessel harvesting system) The kit included three Precision BiPolar Devices, an Optical Vessel... on 2007-05-07. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1156-2007
Status: Terminated
Initiated: 2007-05-07
Posted: 2007-08-09
Terminated: 2008-03-04
Recalling firm: Datascope Corp.
Product: 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
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: 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.
FDA root cause: Other
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.
Quantity in commerce: 1008
Distribution: Worldwide, including USA, Belgium, the Netherlands, and Germany.
Product codes and lots: 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 code GEI

K003587Class IIClearglide Precision Bipolar DeviceETHICON, Inc. / cleared 2000-12-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)