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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 018 01 11 000
Date submitted: 1/8/2011
Manufacturer:Edwards Lifesciences
Device Type:Ascendra 2 Delivery System
Description:Catheter, cardiac, valvuloplasty
Medical Device Identifier:Model Number: 9320AS23 and 9320AS26. all lot numbers
Reason of Field Safety Corrective Action:Edwards Lifesciences is announcing a Field Safety Notice (FSN) on all loader assemblies contained within the Ascendra 2 Delivery Systems (The Ascendra 2 delivery system consists of a balloon catheter and a loader, model number 9320AS23 or 9320AS26). Edwards has received reports where, during the transapical procedure, the loader assembly de-airing mechanism has become partially unseated thereby creating an insufficient seal around the pusher and resulting in the leakage of blood.
Remedy Action:Edwards is issuing this Field Safety Notice to increase clinician awareness and diligence. Edwards is requesting that all Ascendra 2 users review the following information regarding device preparation and take action as described on the attached document
Athorized Representative/Importer/Distributor:Arabian Health Care Supply Co. (AHCSC), Riyadh (01) 4747444
Report Source:NCMDR
Source Ref. Number:EEBA955B322CA
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments: Ascendra Loader Leak - FSN.pdf