Z-2616-2021Class II

Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83...

Name: Z-2616-2021 Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83...
Creator: Datascope Corp.
Published: 2021-09-08
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2021-09-08 / Open, Classified / root cause: software

FDA source

Datascope Corp. began a recall of Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85 on 2021-09-08. FDA classified it as Class II and gives the reason as "The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. This occurs...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2616-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-09-08
Posted: 2021-09-30
Recalling firm: Datascope Corp.
Product: Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Product code: DSP System, Balloon, Intra-Aortic And Control
Reason for recall: The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. This occurs during a very specific set of conditions.
Root cause tag: software
FDA root cause: Software design
Action: On Wednesday, September 8, 2021, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed that all lots of Maquet Cardiosave Hybrid experience the following issue: Unexpected Shutdown Upon Battery Removal. Immediate Actions to be taken by Customers: To ensure that the Cardiosave Hybrid is not susceptible to shutdown during the removal of a battery, users should not eject a battery when: - There is a singulat battery in either battery charging bay and unused battery bay is empty. - The battery is charging on AC power (indicated by a flashing LED on the battery pack). Additionally, the user can prevent the issue by ensuring that a battery is inserted into each of the two battery bays. Should a charging battery be ejected inadvertently, the unit will automatically switch over to the second battery, thus preventing system shutdown. Furthermore, Datascope/Getinge is developing a software correction to address this issue. A Datascope/Getinge service representative will contact you to schedule the installation of the updated software. This work will be done at no cost to your facility. If you have any questions, please contact your Datascope/Getinge representative or call the Datascope/Getinge Technical Support at 1-888-943-8872, options 4, 2, 1, Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
Quantity in commerce: 3969 total (US); 3550 total (OUS)
Distribution: Nationwide domestic distribution. Foreign distribution worldwide.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2616-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2615-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-10-06	2021-09-30
Z-2616-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-10-06	2021-09-30

Product code DSP

K181122Class IICARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp. / cleared 2018-05-31

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)