Datascope Corp/MAQUET, Certain Intra-Aortic Balloon Pumps: Recall - Potential Mechanical Failure of Power Supply Fan Assembly

[Posted 5/12/2014]

AUDIENCE: Risk Manager, Cardiology, Biomedical Engineering

ISSUE: In March 2014, Datascope Corp/MAQUET initiated a voluntary worldwide field correction of certain Intra-Aortic Balloon Pumps (IABPs) sold under the Datascope Corp. System 98/98XT, CS100/CS100i and CS300 brand names for a 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. An IABP shutdown could result in worsened heart failure, decreased blood flow to the heart, and/or decreased blood flow to the body and brain.

BACKGROUND: 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 via the principle of counterpulsation. Between January 1, 2003 and June 30, 2011, specific 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) IABPs were manufactured with an affected fan assembly, or may have received an affected fan assembly during an upgrade/service of the IABP in the field.

RECOMMENDATION: The affected System 98/98XT, CS100, CS100i and CS300 Intra-Aortic Balloon Pumps involved in the field correction can be used while waiting for parts and service. The corrective action associated with this recall is to provide a replacement fan assembly to all IABPs containing an affected fan assembly. A MAQUET Service Representative will contact those facilities with affected IABP’s to schedule corrective action and document this corrective action during a visit to the customer. For additional information regarding this field correction, please contact the Technical Support Department at 1-800-777-4222 and Press 3 (Monday through Friday from 8:00 am – 6:00 pm EST).

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[5/09/2014 - Firm Press Release - Datascope Corp/MAQUET]