Z-1812-2010

CS300 Intra-Aortic Balloon Pump

Name: Z-1812-2010 CS300 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 CS300 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-1812-2010
Status: Terminated
Initiated: 2010-05-10
Posted: 2010-06-21
Terminated: 2010-10-27
Recalling firm: Datascope Corp.
Product: CS300 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 units
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 0998-00-3013-XX SN# SI126162D8 SI120003C8 SI122070C8 SI147171J8 SI124922D8 SI118561B8 SI121095C8 SI121099C8 SI122072C8 SI118566B8 SI119984C8 SI119986C8 SI119994C8 SI119997C8 SI120015C8 SI120021C8 SI120022C8 SI121087C8 SI119989C8 SI118559B8 SI119999C8 SI120000C8 SI120001C8 SI120005C8 SI120009C8 SI120017C8 SI121091C8 SI121100C8 SI124933D8 SI121090C8 SI120008C8 SI124911D8 SI124918D8 SI120004C8 SI120018C8 SI120020C8 SI121085C8 SI121097C8 SI121098C8 SI121103C8 SI121104C8 SI121107C8 SI121117C8 SI122075C8 SI120023C8 SI120019C8 SI121115C8 SI121119C8 SI122073C8 SI120006C8 SI120013C8 SI120014C8 SI121081C8 SI121082C8 SI121083C8 SI121094C8 SI121102C8. International: SI118567B8 SI118558B8 SI135828G8 SI118560B8 SI118565B8 SI119992C8 SI119987C8 SI119988C8 SI124910D8 SI135278G8 SI118562B8 SI119995C8 SI119985C8 SI118563B8 SI121084C8 S8119777B8 SI124923D8 SI121089C8 SI124939D8 SI124937D8 SI118564B8 SI124915D8 SI119991C8 SI119998C8 SI121096C8 SI158367D9 SI124920D8.

Product code DSP

K063525Class IIDatascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and Cs300 Intra-Aortic Balloon Pump Control SystemDatascope Corp. / cleared 2007-01-05

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)