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Terminated

System 98XT/98 Intra-Aortic Balloon Pump This product was only distributed in India and Hong Kong/China.

FDA Recall Z-1813-2010 · Posted 2010-06-21

Recalling FirmDatascope Corporation
Recall StatusTerminated
Product CodeDSP
Date Initiated2010-05-10
Date Terminated2010-10-27
Product Quantity161 units total

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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