Cardiosave Hybrid (Datascope) – IFU Vibration Standards Update (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cardiosave Hybrid
Brand
Datascope Corp.
Lot Codes / Batch Numbers
1) Model: 0998-00-0800-31, UDI-DI: 10607567109053, Serial Numbers: All, 2) Model: 0998-00-0800-32, UDI-DI: 10607567111117, Serial Numbers: All, 3) Model: 0998-00-0800-33, UDI-DI: 10607567109008, Serial Numbers: All, 4)Model: 0998-00-0800-35, UDI-DI: 10607567109107, Serial Numbers: All, 5)Model: 0998-00-0800-36, UDI-DI: 10607567114187, Serial Numbers: All, 6)Model: 0998-00-0800-45, UDI-DI: 10607567108421, Serial Numbers: All, 7)Model: 0998-00-0800-52, UDI-DI: 10607567108438, Serial Numbers: All, 8)Model: 0998-00-0800-53, UDI-DI: 10607567108391, Serial Numbers: All, 9) Model: 0998-00-0800-55, UDI-DI: 10607567108414, Serial Numbers: All, 10) Model: 0998-00-0800-65, UDI-DI: 10607567113432, Serial Numbers: All, 11) Model: 0998-UC-0800-31, UDI-DI: 10607567109053, Serial Numbers: All, 12) Model: 0998-UC-0800-33, UDI-DI: 10607567109008, Serial Numbers: All, 13) Model: 0998-UC-0800-52, UDI-DI: 10607567108438, Serial Numbers: All, 14) Model: 0998-UC-0800-53, UDI-DI: 10607567108391, Serial Numbers: All, 15) Model: 0998-UC-0800-55, UDI-DI: 10607567108414, Serial Numbers: All
Products Sold
1) Model: 0998-00-0800-31; UDI-DI: 10607567109053; Serial Numbers: All; 2) Model: 0998-00-0800-32; UDI-DI: 10607567111117; Serial Numbers: All; 3) Model: 0998-00-0800-33; UDI-DI: 10607567109008; Serial Numbers: All; 4)Model: 0998-00-0800-35; UDI-DI: 10607567109107; Serial Numbers: All; 5)Model: 0998-00-0800-36; UDI-DI: 10607567114187; Serial Numbers: All; 6)Model: 0998-00-0800-45; UDI-DI: 10607567108421; Serial Numbers: All; 7)Model: 0998-00-0800-52; UDI-DI: 10607567108438; Serial Numbers: All; 8)Model: 0998-00-0800-53; UDI-DI: 10607567108391; Serial Numbers: All; 9) Model: 0998-00-0800-55; UDI-DI: 10607567108414; Serial Numbers: All; 10) Model: 0998-00-0800-65; UDI-DI: 10607567113432; Serial Numbers: All; 11) Model: 0998-UC-0800-31; UDI-DI: 10607567109053; Serial Numbers: All; 12) Model: 0998-UC-0800-33; UDI-DI: 10607567109008; Serial Numbers: All; 13) Model: 0998-UC-0800-52; UDI-DI: 10607567108438; Serial Numbers: All; 14) Model: 0998-UC-0800-53; UDI-DI: 10607567108391; Serial Numbers: All; 15) Model: 0998-UC-0800-55; UDI-DI: 10607567108414; Serial Numbers: All;
Datascope Corp. is recalling Cardiosave Hybrid due to The IFU addendum updates the Vibration and Shock Table to reference the correct standards.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
Recommended Action
Per FDA guidance
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).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026