Z-0931-2026Class III

Cardiosave Hybrid

Name: Z-0931-2026 Cardiosave Hybrid
Creator: Datascope Corp.
Published: 2025-10-23
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2025-10-23 / Open, Classified / root cause: labeling and UDI

FDA source

Datascope Corp. began a recall of Cardiosave Hybrid on 2025-10-23. FDA classified it as Class III and gives the reason as "The IFU addendum updates the Vibration and Shock Table to reference the correct standards". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0931-2026
Classification: Class III
Status: Open, Classified
Initiated: 2025-10-23
Posted: 2025-12-16
Recalling firm: Datascope Corp.
Product: Cardiosave Hybrid
Product code: DSP System, Balloon, Intra-Aortic And Control
Reason for recall: The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
Root cause tag: labeling and UDI
FDA root cause: Process change control
Action: 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 [email protected]. 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).
Quantity in commerce: 11470 units (5095 US, 6375 OUS)
Distribution: Domestic: Nationwide distribution. International: Albania, Algeria, Angola, Argentina, Armenia, Republic of, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia And Herzegovina, Botswana, Republic of, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, C¿te d Ivoire, (Ivory Coast), Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Ghana, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Republic of, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Myanmar, (Burma), Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, Pakistan, Palestine Territory, Peru, Philippines, Poland, Portugal, Qatar, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Republic Of China, Tanzania, United Republic Of, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Yemen, Zambia;
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0931-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0931-2026	Class III	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-16
Z-0932-2026	Class III	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-16

Product code DSP

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)