FDA Medical Device Recalls (openFDA)
Datascope Corp.: Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
- Recall number
- Z-1907-2023
- Recalling firm
- Datascope Corp.
- Product
- Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
- Status
- Open, Classified
- Initiated
- 2023-05-04
- Posted
- 2023-06-14
- Terminated
- not on file
- Reason
- The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.
- Root cause
- Under Investigation by firm
- Action
- An URGENT FIELD SAFETY NOTICE MEDICAL DEVICE CORRECTION notification letter was sent to customer on 5/4/23. Actions to be taken by the customer: " Please locate the CARDIOSAVE Hybrid IABPs with the serial numbers listed in this notice. " Please ensure that all Cardiosave Hybrid Intra-Aortic Balloon Pump users at your facility are aware of this notice. " Please forward this information to all current and potential Cardiosave Hybrid IABPs users within your hospital / facility. " Please contact your local Getinge Service Representative to arrange to have the affected IFU USB drives replaced. " Please complete and sign the attached URGENT FIELD SAFETY NOTICE RESPONSE FORM (page 3) to acknowledge that you have received this notification. Return the completed form to Datascope Corp./Getinge by e-mailing a scanned copy to fieldaction@getinge.com Actions to be taken by Getinge: Getinge will provide your facility with an updated IFU USB drive that contains reference to the vibration testing standard, 60601-1-12:2014. The original USB drive that was provided during the D.00 software update can be destroyed locally. This voluntary correction notification only affects the products listed on page 1; no other products are affected by this voluntary correction. We apologize for any inconvenience this Medical Device Correction may cause. If you have any questions, please contact your Datascope Corp./Getinge representative.
- Quantity
- 4 units
- Distribution
- International distribution in the country of Germany.
- Lot, serial or model codes
- UDI-DI: 10607567108414; Serial Numbers: CB286971I8 CB283804G8 CB283867G8 CB283522G8
- 510(k) numbers
- ["K112372"]
- PMA numbers
- not on file
- Product code
- DSP
- Firm FEI
- 3001418283
- 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