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U.S. Department of Health and Human Services

Enforcement Report - Week of May 28, 2014

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Product Detail

Product Description Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump Product Usage: The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures.
Recall Number Z-1523-2014
Classification Class I
Code Info IABP Model Numbers System 98 0998-00-0446-xx 0998-UC-0446-xx System 98XT 0998-00-0479-xx 0998-UC-0479-xx CS100i 0998-UC-0446Hxx 0998-UC-0479Hxx CS100 0998-00-3013-xx 0998-UC-3013-xx CS300 0998-00-3023-xx 0998-UC-3023-xx
Product Distributed Qty 11,881 units (US 5183 and OUS 6698)
Reason For Recall Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure could result in the power supply overheating and cause the IABP to shut down without warning.

Event Detail

Event Id 67815
Product Type Devices
Status Ongoing
Recalling Firm Maquet Datascope Corp - Cardiac Assist Division
City Mahwah
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-03-21
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA (nationwide), worldwide to approximately 104 countries.