Bridge Occlusion Balloon Catheter Model 590-001 by Spectranetics: Class I Recall - Clinical Issue

By Newsroom America Feeds at 25 Sep 2017

If device with blocked guidewire lumen were used, device would not be positioned correctly and hemorrhage would not be controlled, delaying life-saving treatment, which may result in serious adverse health consequences, including death.

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm577336.htm

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