Z-1813-2010

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

Name: Z-1813-2010 System 98XT/98 Intra-Aortic Balloon Pump This product was only distributed in India and Hong Kong/China
Creator: Datascope Corporation
Published: 2010-05-10
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2010-05-10 / Terminated

FDA source

Datascope Corporation began a recall of System 98XT/98 Intra-Aortic Balloon Pump This product was only distributed in India and Hong Kong/China on 2010-05-10. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1813-2010
Status: Terminated
Initiated: 2010-05-10
Posted: 2010-06-21
Terminated: 2010-10-27
Recalling firm: Datascope Corp.
Product: System 98XT/98 Intra-Aortic Balloon Pump This product was only distributed in India and Hong Kong/China.
Product code: DSP System, Balloon, Intra-Aortic And Control
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.
FDA root cause: Other
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.
Quantity in commerce: 161 units total
Distribution: 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.
Product codes and lots: Product number 0998-00-0446-XX and 0998-00-0479-XX. SN# S8119767B8 S8119768B8 S8119769B8 S8119771B8 S8119773B8 S8119774B8 S8119775B8 S8119778B8 S8119780B8 S8119781B8 S8119782B8 S8119764B8 S8119766B8 S8119770B8 S8119772B8 S8119776B8 S8119779B8

Product code DSP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)