Class I Recall Issued for Intra-Aortic Balloon Pumps (IABPs)

In March 2011, Datascope Corp/Maquet initiated a voluntary worldwide field correction of certain I<"http://www.yourlawyer.com/practice_areas/defective_medical_devices">ntra-Aortic Balloon Pumps (IABPs) that were sold under Datascope Corp. Systems 98/98XT, CS100/CS100i, and CS300, the U.S. Food and Drug Administration (FDA) just announced. A total of 840 U.S. customer IABPs and 453 international customer IABPs are affected by this field correction.

The FDA has designated this action as a Class 1 recall, which means that this recall represents 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. The recalled items include:

• 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)

• CS300 ( Part Numbers: 0998-00-3023-xx, 0998-UC-3023-xx) IABP brand names.

Customers with the recalled 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, may schedule a visit by a Service Representative by contacting the US Call Center at 1.800.777.4222, Press 3.

Between May 2008 and December 2010 specific System 98/98XT, CS100/CS100i, and CS300 IABPs were manufactured with an affected power supply. The devices may also 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. Device failure may result in unanticipated interruption of counterpulsation therapy.

Datascope Corp/Maquet initiated the field correction in March 2011 and, at that time, notified all customers who may have an IABP affected by this field correction. The corrective action associated with this field correction was meant 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 percent of U.S. customer units have been completed and every effort is being made to complete all affected domestic IABPs as soon as possible.

The firm’s Technical Support department can be reached 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 by a Field Service Representative, the firm’s U.S. Call Center can be reached at 1.800.777.4222; Press 3 (Monday though Friday from 8:30 a.m. to 5:30 p.m. EST). The U.S. Call Center can be reached after business hours at 1.800.777.4222; 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 telephone at 1.800.FDA.1088; by Fax at 1.800.FDA.0178; by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787; or on the MedWatch website at www.fda.gov/medwatch.

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