Spectranetics Bridge Occlusion Balloon Catheters Recalled

Washington, DC: Spectranetics is recalling its Bridge Occlusion Balloon Catheter due to the possibility of a blocked guidewire lumen in some device units.

Spectranetics’ Bridge Occlusion Balloon Catheter is a device intended to temporarily block the superior vena cava (SVC) when emergency control of hemorrhage is required. The Bridge Occlusion Balloon catheter is constructed of a compliant balloon mounted on a dual lumen shaft. The guidewire lumen is used to pass the catheter over a guide wire.

According to the US Food & Drug Administration recall notice, if a device with a blocked guidewire lumen were to be used during the procedure, the device would not be positioned correctly and hemorrhage would not be controlled. This would delay life-saving treatment, which may result in immediate and serious adverse health consequences, including death.
 

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Published on Sep-27-17