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Voluntary Worldwide Field Correction Issued for the S98/98XT, CS100/CS100i and CS300 Intra-Aortic Balloon Pumps
Date:6/6/2011

MAHWAH, N.J., June 6, 2011 /PRNewswire/ -- In March 2011, Datascope Corp/Maquet initiated a voluntary worldwide field correction of certain Intra-Aortic Balloon Pumps (IABPs) sold under the Datascope Corp. System 98/98XT (Part numbers: 0998-00-0446-xx, 0998-UC-0446-xx, 0998-00-0479-xx, 0998-UC-0479-xx), CS100/CS100i (Part Numbers: 0998-00-3013-xx, 0998-UC-3013-xx, 0998-UC-0446Hxx and 0998-UC-0479Hxx) and CS300 ( Part Numbers: 0998-00-3023-xx, 0998-UC-3023-xx) IABP brand names.  Customers who have 98/98XT, CS100/CS100i and CS300 Intra-Aortic Balloon Pumps (IABPs) sold under the Datascope Corp. System 98/98XT, CS100/CS100i and CS300 IABP brand names which are being recalled may schedule a visit by a Service Representative by contacting the US Call Center at 1-800-777-4222, Press 3.

A total of 840 US customer IABPs and 453 international customer IABPs are affected by this field correction. Between May 2008 and December 2010 specific System 98/98XT, CS100/CS100i and CS300 IABPs were manufactured with an affected power supply, or may have received an affected power supply during an upgrade/service of the IABP in the field.  In specific units, the fan assembly of the power supply could potentially contain a misshapen retaining ring.  This retaining ring could disengage within the fan, causing the fan blade assembly to stop rotating.  Consequently, the power supply would detect an overheating event, and shut down without visual or audible alarms.  The data to date indicates that there is a very small likelihood for an IABP to contain a misshapen retaining ring.  This device failure may result in unanticipated interruption of counterpulsation therapy.

The U.S. Food and Drug Administration ("FDA") has classified this action as a Class 1 recall. FDA defines Class I recalls as, "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences
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SOURCE MAQUET Cardiovascular
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