OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 070 07 14 000
Date submitted: 7/16/2014
Manufacturer:Vascutek Limited
Device Type:Gelweave, Thoraflex Hybrid, BioValsalva Stentless Biplex, Stented BioValsalva Biplex and RVOT elan Biplex
Medical Device Identifier:-All Gelsoft™, Gelsoft Plus™, K-Thin, Gelsoft Plus™ ERS, K-Thin ERS, Gelseal™, Gelseal Plus™, Gelseal™ ERT and Gelweave™ Vascular Prostheses -All Thoraflex™ Hybrid Devices -All BioValsalva™ Stentless Biplex™ Conduits -All Stented BioValsalva™ Biplex™ Conduits -All RVOT elan™ Biplex™ Conduits Lot/Serial Number : All Lots
Reason of Field Safety Corrective Action:This notice is to inform you about important updates to the above products and their Instructions for Use (IFU).
Remedy Action:-Vascutek advises that you ensure suitable equipment is available prior to implantation to trim the graft if required.

-For product received with a cautery in the interim, Vascutek request that you check the shelf life of each product before every operation. If you find that the cautery is out of date, please contact your local representative who will organise reimbursement. If you require an appropriate cautery supplied as a separate item, please contact your local Vascutek representative.

-Vascutek are taking this opportunity to reinforce the cautions regarding soaking of the graft in saline to prevent focal burning if a cautery is to be used. This statement is already included in the IFU and now appears in bold, red font to ensure appropriate awareness.
Athorized Representative/Importer/Distributor:Gulf Medical Co., (012) 6512828
Report Source:NCMDR
Source Ref. Number:2449E3C4EF303
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Vascutek.pdf