Spectranetics Corp. Recalls Bridge Occlusion Balloon Catheter Due to Risk of Blocked Guidewire Lumen Preventing Balloon Utilization

["U.S. Food and Drug Administration" <fda@xxxxxxxxxx>]

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	Spectranetics Corp. Recalls Bridge Occlusion Balloon Catheter Due to Risk of Blocked Guidewire Lumen Preventing Balloon Utilization
	Spectranetics is recalling its Bridge Occlusion Balloon Catheter due to the possibility of a blocked guidewire lumen in some device units. 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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