Z-0625-2010

Sorin / Clearglide EVH Low Profile, REF KTV16, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401...

Name: Z-0625-2010 Sorin / Clearglide EVH Low Profile, REF KTV16, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401...
Creator: Sorin Group USA, Inc.
Published: 2009-11-25
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2009-11-25 / Terminated

FDA source

Sorin Group USA, Inc. began a recall of Sorin / Clearglide EVH Low Profile, REF KTV16, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004. The device is indicated... on 2009-11-25. The reason FDA records is "Vessel clamping device may break during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0625-2010
Status: Terminated
Initiated: 2009-11-25
Posted: 2010-01-14
Terminated: 2010-10-04
Recalling firm: LivaNova USA, Inc.
Product: Sorin / Clearglide EVH Low Profile, REF KTV16, 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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Vessel clamping device may break during use.
FDA root cause: Component change control
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.
Quantity in commerce: 534 units
Distribution: Worldwide Distribution -- United States, Australia, Canada and Italy.
Product codes and lots: Lot Num,bers: 0910500009, 0912400208, 0915300001, 0922900039, 0925100117, 0927200177, 0929900093.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)