Z-1232-2023Class II

Cardiosave Rescue. Model Number: 0998-00-0800-83

Name: Z-1232-2023 Cardiosave Rescue. Model Number: 0998-00-0800-83
Creator: Datascope Corp.
Published: 2023-02-07
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2023-02-07 / Open, Classified / root cause: manufacturing process

FDA source

Datascope Corp. began a recall of Cardiosave Rescue. Model Number: 0998-00-0800-83 on 2023-02-07. FDA classified it as Class II and gives the reason as "Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, therapy will be interrupted". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1232-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-07
Posted: 2023-03-06
Recalling firm: Datascope Corp.
Product: Cardiosave Rescue. Model Number: 0998-00-0800-83.
Product code: DSP System, Balloon, Intra-Aortic And Control
Reason for recall: Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, therapy will be interrupted.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Firm notified customers on February 7, 2023, in an Urgent Medical Device Correction letter which discussed four issues in total - this issue was Issue #4. Customers were instructed to contact their Datascope/Getinge service representative if they observe any visual damage to the O-ring installed as part of the quick disconnect fitting. Datascope/Getinge is currently updating the annual Preventive Maintenance instruction to include replacement of the quick disconnect fitting O-ring. 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). On 11/04/2025 the recall was expanded, and consignees were notified via letter. The notification was for awareness to the update of Datascope s preventative maintenance in the IFU addendum, which was provided to consignees. The IFU Addendum contains an updated Schedule B Preventive Maintenance Schedule which calls for the Quick Disconnect Fitting O-Ring to be replaced and to lubricate the console release latch every 12 months or 2500 hours. The Service Manual has contained this update to Preventive Maintenance for the Helium O-Ring since June 2023. Consignees were instructed to review the IFU Addendum and local Preventive Maintenance Schedule and update their Preventive Maintenance schedule accordingly.
Quantity in commerce: 47 units (44 US, 3 OUS)
Distribution: Nationwide US distribution. Worldwide international distribution.
Product codes and lots: Model Number: 0998-00-0800-83. UDI-DI: 10607567108407. All serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1232-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1231-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-15	2023-03-06
Z-1232-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-15	2023-03-06

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)