CS100 Intra-Aortic Balloon Pump.
FDA Recall Z-1811-2010 · Posted 2010-06-21
Recalling FirmDatascope Corporation
Recall StatusTerminated
Product CodeDSP
Date Initiated2010-05-10
Date Terminated2010-10-27
Product Quantity161 total devices
Reason for Recall
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.
Firm Action
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.
Root Cause
Other
Distribution Pattern
Class 2 - Worldwide distribution -- US and Distribution to Australia, Belarus, Belgium, Canada, Egypt, England, Germany, Hong Kong, India, Iran, Israel, Japan, Kuwait, Latvia, Lebanon, Serbia, Singapore, Spain, Switzerland, Turkey, Venezuela.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.