Z-1907-2023Class III

Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX

Name: Z-1907-2023 Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
Creator: Datascope Corp.
Published: 2023-05-04
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2023-05-04 / Open, Classified / root cause: labeling and UDI

FDA source

Datascope Corp. began a recall of Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX on 2023-05-04. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1907-2023
Classification: Class III
Status: Open, Classified
Initiated: 2023-05-04
Posted: 2023-06-14
Recalling firm: Datascope Corp.
Product: Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
Product code: DSP System, Balloon, Intra-Aortic And Control
Reason for recall: 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 tag: labeling and UDI
FDA 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 [email protected] 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 in commerce: 4 units
Distribution: International distribution in the country of Germany.
Product codes and lots: UDI-DI: 10607567108414; Serial Numbers: CB286971I8 CB283804G8 CB283867G8 CB283522G8

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1907-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1907-2023	Class III	Ongoing	Voluntary: Firm initiated	2023-06-21	2023-06-14

Product code DSP

K112372Class IICardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC / cleared 2011-09-15

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)