Tag: recall

FDA Classifies Spectranetics’ Bridge Occlusion Balloon as Class I Recall

Bridge Occlusion Balloon Catheter Model 590-001 by Spectranetics: Class I Recall – Risk of Blocked Guidewire Lumen Preventing Balloon Utilization ISSUE: 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 […]

Datascope Corp./MAQUET Issues Worldwide Voluntary Recall of the System CS100, CS100i and CS300 Intra-Aortic Balloon Pumps for Potential Electrical Test Failure Code

WAYNE, N.J., June 16, 2017 /PRNewswire/ — Datascope Corp. is voluntarily performing a worldwide field correction of certain Intra-Aortic Balloon Pumps (IABPs) sold by Datascope Corp. for a potential electrical test failure code. AFFECTED PRODUCT PART NUMBER CS100i IABP CS100 IABP CS300 IABP 0998-UC-0446HXX; 0998-UC-0479HXX 0998-00-3013-XX;  0998-UC-3013-XX 0998-00-3023-XX;  0998-UC-3023-XX This […]