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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 086 07 11 000
FlexCath Steerable Sheaths
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.
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.
Gulf Medical Co. Jeddah (02) 6512828
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.