Datascope Corp Datascope CS 100 Intra-Aortic Balloon Pump and Datascope CS 300 Intra-Aortic Balloon Pump, Datascope Corp. Mahwah, NJ 07430 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Datascope CS 100 Intra-Aortic Balloon Pump and Datascope CS 300 Intra-Aortic Balloon Pump, Datascope Corp. Mahwah, NJ 07430
Brand
Datascope Corp
Lot Codes / Batch Numbers
just the board contained within.)
Products Sold
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.)
Datascope Corp is recalling Datascope CS 100 Intra-Aortic Balloon Pump and Datascope CS 300 Intra-Aortic Balloon Pump, Datascope due to 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 exhib. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026