Z-0567-2008

Datascope CS 100 Intra-Aortic Balloon Pump and Datascope CS 300 Intra-Aortic Balloon Pump, Datascope Corp...

Name: Z-0567-2008 Datascope CS 100 Intra-Aortic Balloon Pump and Datascope CS 300 Intra-Aortic Balloon Pump, Datascope Corp...
Creator: Datascope Corp
Published: 2007-11-19
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2007-11-19 / Terminated

FDA source

Datascope Corp began a recall of Datascope CS 100 Intra-Aortic Balloon Pump and Datascope CS 300 Intra-Aortic Balloon Pump, Datascope Corp. Mahwah, NJ 07430 on 2007-11-19. The reason FDA records is "Defective Circuit Board -- A defect in the Printed Circuit Board's (PCB) in the CS 100 and CS300 Intra-Aortic Balloon Pump may cause the pump to exhibit intermittent malfunctions, which include failure to start-up or...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0567-2008
Status: Terminated
Initiated: 2007-11-19
Posted: 2008-01-31
Terminated: 2008-05-20
Recalling firm: Datascope Corp.
Product: Datascope CS 100 Intra-Aortic Balloon Pump and Datascope CS 300 Intra-Aortic Balloon Pump, Datascope Corp. Mahwah, NJ 07430
Product code: DSP System, Balloon, Intra-Aortic And Control
Reason for recall: Defective Circuit Board -- A defect in the Printed Circuit Board's (PCB) in the CS 100 and CS300 Intra-Aortic Balloon Pump may cause the pump to exhibit intermittent malfunctions, which include failure to start-up or reset of the display screen during therapy.
FDA root cause: Other
Action: Datascope sent a Product Field Correction notification letters to Hospital Administrators, via certified mail, on November 19, 2007. The letter informed them of a defect in the circuit board. It described the possible malfunction and provided instructions should malfunctioning occur. Datascope will be replacing the defective circuit boards in all affected IABP units. A Service Representative will be contacting the hospital to arrange for the replacement of the defective board.
Quantity in commerce: 70 units US
Distribution: Worldwide Distribution
Product codes and lots: Serial Numbers: S805991-C2 S805993-C2 SA02504-C4 S806332-G2 S82934-H9 SA03941-F5 S82416-D9 S805969-C2 S806909-B3 S806924-B3 SA03395-A5 SA03407-A5 SI101373-H7 S805404-H1 S81758-K8 S807356-F3 S807013-C3 S806289-F2 S806308-G2 S806282-F2 S806306-G2 S806284-F2 S806292-F2 S806297-G2 SA04871-A6 S806286-F2 S806926-B3 S804246-J0 S805797-A2 S804934-D1 S806155-E2 SI101367-H7 SI100417-H7 S807506-J3 S807042-C3 S81471-I8 SA02801-G4 S8233778-E0 S82518-E9 S803467-B0 SA03469-B5 S806229-F2 S804255-J0 S806193-E2 S806025-D2 S806012-D2 S806019-D2 S806045-D2 S806017-D2 S806024-D2 S805992-C2 S806009-D2 S805581-I1 S82350-C9 S804783-B1 S804793-B1 S804799-B1 S806859-A3 SA01430-A4 SA01152-I3 SA01421-A4 SA01412-A4 S803857-F0 S803775-E0 SA02521-D4 SI01410-E7 S807446-G3 S807470-H3 S806225-F2 and S806259-F2 (These serial numbers do not differentiate between CS100 and CS300, just the board contained within.)

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)