Recall Class: Class I

Date Recall Initiated: March 16, 2011

Product(s): System 98/98XT, CS100/CS100i and CS300 Intra-Aortic Balloon Pumps manufactured between May2008 and December 2010. 885 devices are subject to this recall. Affected lot/serial numbers include 7081436, 7081963, 7083463, and 7090616.

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 describing 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.

Reason for Recall: A defective fan in the power supply may cause overheating and shut down the device without visible or audible alarms. Consequences of unanticipated interruption of therapy may include the inability to decrease already-present ischemia, thrombus formation, organ injury or other serious events.

Use: 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.

Recalling Firm:

Maquet Datascope Corporation – Cardiac Assist Division

1300 MacArthur Blvd.

Mahwah, New Jersey 07430

Public Contact:

Maquet Technical Support Department at 1-800-777-4222 and Press 4 (M-F from 9:00 am-5:30 pm EST). For scheduling a service visit by a Field Service Representative, contact 1-800-777-4222 and Press 3 (M-F from 8:30 am 5:30 pm EST).

FDA District: New Jersey

FDA Comments:

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

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