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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 012 09 12 000
Date submitted: 9/2/2012
Manufacturer:Abbott Vascular Devices Div Abbott Laboratories Inc
Device Type:Catheter, Armada 35 and Armada 35 LL Percutaneous Transluminal Angioplasty (PTA) Catheter
Medical Device Identifier: Lot Numbers: All lots up to and including Lot Number 783705 find attached Part Numbers
Reason of Field Safety Corrective Action: Abbott Vascular has discovered that some devices may exhibit difficulty inflating and/or deflating. Potential risks associated with this event include prolonged procedure times, additional physician intervention including minor surgery and possible thrombus. There have been no long term or irreversible patient effects reported.
Remedy Action: The use of these devices should cease immediately, and return all unused devices to Abbott Vascular. Abbott Vascular will work with you to replace returned units with similar product, pending availability.
Athorized Representative/Importer/Distributor:Gulf Medical Co., Jeddah, (02) 6512828
Report Source:NCMDR
Source Ref. Number:A343FB0C1C209
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott Vascular Devices Div Abbott Laboratories Inc.pdf