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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