Datascope Corp. Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0800-35, D998-00-0800-36, D998-00-0800-45, D998-00-0800-52, D998-00-0800-53, D998-00-0800-55, D998-00-0800-65, D998-00-0800-83, D998-UC-0800-31, D998-UC-0800-33, D998-UC-0800-52, D998-UC-0800-53, D998-UC-0800-55. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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.