FDA Medical Device Recalls (openFDA)
Datascope Corp: Datascope CS 100 Intra-Aortic Balloon Pump and Datascope CS 300 Intra-Aortic Balloon Pump, Datascope Corp. Mahwah, NJ 07430
- Recall number
- Z-0567-2008
- 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
- Status
- Terminated
- Initiated
- 2007-11-19
- Posted
- 2008-01-31
- Terminated
- 2008-05-20
- Reason
- 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.
- 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
- 70 units US
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- 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.)
- 510(k) numbers
- ["K063525"]
- PMA numbers
- not on file
- Product code
- DSP
- Firm FEI
- 2221819
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28