Bridge Occlusion Balloon Catheter Model 590-001 by Spectranetics: Class I Recall - Risk of Blocked Guidewire Lumen Preventing B
Date of publication: 26-09-2017
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. Źródło: https://www.fda.gov