Recall -- Firm Press Release
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Voluntary Worldwide Field Correction Issued for the S98/98XT, CS100/CS100i and CS300 Intra-Aortic Balloon Pumps
Technical Support: 1-800-777-4222 x4
Field Service Representative: 1-800-777-4222 x3
US Call Center (after hours): 1-800-777-4222 x0
FOR IMMEDIATE RELEASE - June 6, 2011 - 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 or death."
Datascope Corp/Maquet initiated the field correction in March 2011 and at that time notified all customers that may have an IABP affected by this field correction. The corrective action associated with this field correction is to provide an upgraded power supply to all IABPs containing an affected power supply. A Service Representative will conduct the upgrade and document this corrective action during a visit to the customer. To date, 55% of US customer units have been completed and every effort is being made to complete all affected domestic IABPs as soon as possible.
For additional information regarding this field correction, please contact the Technical Support Department at 1-800-777-4222 and Press 4 (Monday through Friday from 9:00 am-5:30 pm EST). For scheduling a service visit by a Field Service Representative, please contact our US Call Center at 1-800-777-4222 and Press 3 (Monday though Friday from 8:30 am 5:30 pm EST). To contact the US Call Center after business hours, please contact 1-800-777-4222, and Press 0.
Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.