FDA Device

CS100 Intra-Aortic Balloon Pump.

Hazard

Certain MAQUET/Datascope Intra-Aortic Balloon Pumps (IABP) have the potential to experience display related issues. Although the IABP continues to deliver therapy to the patient, display related issues may cause the user to be unable to view the IABP on the information screen.

What You Should Do

Remedy

Medical Device Recall Letters were sent to Hospital Administrators beginning May 10, 2010 by overnight mail. Customers with questions are directed to contact your local Sales/Service Representative or the company representative at 973-244-6314.

Products

CS100 Intra-Aortic Balloon Pump.
Brand
Datascope Corporation
UPC
Product number 0998-00-3023-XX: SA122365C8 SA122373C8. International: SA122359C8 SA122375C8 SA122358C8 SA122360C8 SA122363C8 SA122362C8 SA122361C8 SA122368C8 SA147699K8 SA122366C8 SA122370C8 SA119292B8 SA122371C8 SA122364C8 SA122367C8 SA122369C8 SA122372C8.

Units Affected

161 total devices