Datascope Corporation The ClearGlide EVH small with Scissors. The kit includes three Precision Bipolar Devices, an Optical Vessel Dissector, a Small Ultra Retractor, a Vessel Dissector, and the ENDOPATH 5mm curved scissors. Datascope Cardiac Assist Sterile Manufactured for: Datascope Cardiac Assist 15 Law Drive Fairfield, NJ 07004 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
The ClearGlide EVH small with Scissors. The kit includes three Precision Bipolar Devices, an Optical Vessel Dissector, a Small Ultra Retractor, a Vessel Dissector, and the ENDOPATH 5mm curved scissors. Datascope Cardiac Assist Sterile Manufactured for: Datascope Cardiac Assist 15 Law Drive Fairfield, NJ 07004
Brand
Datascope Corporation
Lot Codes / Batch Numbers
Part Number KTV 17 Lot numbers: 12492, Exp. 4/30/09, 12502, Exp. 4/27/09, 12512, Exp. 5/6/09.
Products Sold
Part Number KTV 17 Lot numbers: 12492, Exp. 4/30/09; 12502, Exp. 4/27/09; 12512, Exp. 5/6/09.
Datascope Corporation is recalling The ClearGlide EVH small with Scissors. The kit includes three Precision Bipolar Devices, an Optical due to Datascope has experienced a higher than usual number of reports involving the Precision Bipolar Device. Reports include the locking or sticking of th. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026