Datascope Corp. recalls Cardiosave Hybrid. Intra-Aortic Balloon Pump system.

The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.

Cardiosave Hybrid. Intra-Aortic Balloon Pump system.

An URGENT MEDICAL DEVICE CORRECTION NOTICE, dated October 2025, was sent via FEDEX to consignees. The notification notifies consignees of four addendum updates: 1) NVRAM Preventive Maintenance (New FSCA - reflected in this recall entry), 2) Vibration and Shock Table Specifications (New FSCA), 3) Helium O-Ring Preventive Maintenance (FSCA 2249723-01/24/2023-004-C), and 4) Battery Runtime Specifications (FSCA 2249723-09/10/2021-001-R). The notification instructs consignees regarding the NVRAM Preventive Maintenance to review the provided IFU addendum, update local preventive maintenance procedures as such, and ensure all NVRAM batteries are within their life expectancy. If a NVRAM is greater than 8 years old, until it can be replaced, it is advised a back-up Cardiosave IABP be available to provide therapy. Consignees with any questions can contact Datascope/Getinge Customer Support at 1-88-943-8872 (options 4, 2, 1) Monday through Friday, from 8:00 AM EST and 6:00 PM EST.

• FDA enforcement recordOfficial FDA database entry for Z-0916-2026
• FDA 510(k) clearance · K112372The device's official FDA premarket clearance record
• FDA 510(k) clearance · K151254The device's official FDA premarket clearance record
• FDA 510(k) clearance · K181122The device's official FDA premarket clearance record
• FDA device classification · DSPOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.3535The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Datascope Corp.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.