Z-1811-2010

CS100 Intra-Aortic Balloon Pump

Name: Z-1811-2010 CS100 Intra-Aortic Balloon Pump
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 CS100 Intra-Aortic Balloon Pump 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-1811-2010
Status: Terminated
Initiated: 2010-05-10
Posted: 2010-06-21
Terminated: 2010-10-27
Recalling firm: Datascope Corp.
Product: CS100 Intra-Aortic Balloon Pump.
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 total devices
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 0998-00-3023-XX: SA122365C8 SA122373C8. International: SA122359C8 SA122375C8 SA122358C8 SA122360C8 SA122363C8 SA122362C8 SA122361C8 SA122368C8 SA147699K8 SA122366C8 SA122370C8 SA119292B8 SA122371C8 SA122364C8 SA122367C8 SA122369C8 SA122372C8.

Product code DSP

K031636Class IICs100 Intra-Aortic Balloon Pump, Model 0998-00-3013-XxDatascope Corp. / cleared 2003-08-11

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)