Maquet Datascope Recalls Intra-Aortic Balloon Catheter Pumps

A defective fan in the power supply may cause overheating and shut down of the <"">Maquet Datascope’s Intra-Aortic Balloon Catheter Pump without visible or audible alarms, the U.S Food and Drug Administration (FDA) just announced. The defective devices have been recalled as a Class I, the agency’s most serious designation.

A Class I designation means that the recall involves situations in which there is a reasonable probability that use of the recalled products will cause serious adverse health consequences or death. The recall was initiated on March 16, 2011 by Maquet Datascope Corporation – Cardiac Assist Division at
1300 MacArthur Boulevard, Mahwah, New Jersey, 07430.

In this case, consequences of unanticipated interruption of therapy may include the inability to decrease already-present ischemia, thrombus formation, organ injury or other serious events. The intra-aortic balloon pump is an electromechanical system used to inflate and deflate an intra-aortic balloon to provide temporary support to the left ventricle of the heart during cardiac surgery.

The recall involves the System 98/98XT, CS100/CS100i, and CS300 Intra-Aortic Balloon Pumps manufactured between May 2008 and December 2010; 885 devices are subject to this recall. Affected lot/serial numbers include 7081436, 7081963, 7083463, and 7090616. Following are the affected models:

• 0998-00-0446-xx
• 0998-UC-0446-xx
• 0998-00-0479-xx
• 0998-UC-0479-xx
• 0998-UC-0446Hxx
• 0998-UC-0479Hxx
• 0998-00-3013-xx
• 0998-UC-3013-xx
• 0998-00-3023-xx
• 0998-UC-3023-xx

Maquet Datascope Corporation notified customers by letter on March 17, 2011 and described the problem, the potential hazard, and the action to be taken. Customers were advised that their Service Representative would arrange to replace the power supply on affected devices, which would contain a new fan assembly. Maquet Technical Support Department can be reached, toll-free, at 1.800.777.4222 (Press 4 ), Monday through Friday from 9:00 a.m. to 5:30 p.m., Eastern Standard Time (EST). To schedule a service visit with a Field Service Representative, contact 1.800.777.4222 (Press 3), Monday through Friday, from 8:30 a.m. to 5:30 p.m. EST).

Health care professionals and consumers may report adverse reactions or quality problems when using these products to FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by FAXL Complete and submit the report online at; download the form at or call 1.800.332.1088 to request a reporting form. Complete and return the form to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

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