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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 086 07 11 000
Date submitted: 7/23/2011
Manufacturer:Medtronic Inc
Device Type:FlexCath Steerable Sheaths
Description:Catheter Introducers-Hemostasis Valve
Medical Device Identifier:FlexCath 12 Steerable Sheath, Model 3FC12
Reason of Field Safety Corrective Action:physicians using FlexCath with Arctic Front Cryoablation Catheters have reported cases of blood and saline solution leaking out of, and air ingress into, the FlexCath 12 hemostatic valve. This includes reported instances of the introduction of air bubbles through the valve during aspiration of the side port of the sheath.
Remedy Action:Medtronic recommend that physicians continue to use the FlexCath 12 Steerable Sheath and as with any catheter usage, remain vigilant when flushing and aspirating the FlexCath sheath and watch closely for any blood loss, saline leakage or air ingress as stated within the existing FlexCath 12 Steerable Sheath and Arctic Front CryoAblation Catheter Instructions For Use.
Athorized Representative/Importer/Distributor:Gulf Medical Co. Jeddah (02) 6512828
Report Source:NCMDR
Source Ref. Number:8FCAE690A6375
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments: Medtronic letter.pdf