Datascope Corp. recalls Cardiosave Hybrid

The IFU addendum updates the Vibration and Shock Table to reference the correct standards.

Cardiosave Hybrid

On November 4, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: 1. Review the IFU Addendum. An IFU Addendum was created to reference the appropriate Transportation Standards that were tested in product specifications. Please forward this information to all current and potential Cardiosave IABP users within your facility. Complete and sign the attached Response Form to acknowledge that you have received and understand this notification. Return the completed form to recallresponses.qrc@getinge.com. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. Actions to be taken by Datascope: Datascope created an IFU Addendum with a clarification to the Vibration and Shock Table IFU information. If you require a physical copy, please contact your local Datascope/Getinge representative, and one will be provided to you at no cost. We apologize for any inconvenience this correction may cause. If you have any questions, please call Datascope/Getinge Customer 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).

• FDA enforcement recordOfficial FDA database entry for Z-0931-2026
• 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 · K163542The 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.