Recall archive / FDA device enforcement
Cardiosave Hybrid — FDA record Z-0931-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 23, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Cardiosave Hybrid
- Reason
- The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
- Classification
- Class III
- Recalling firm
- Datascope Corp.
- Quantity
- 11470 units (5095 US, 6375 OUS)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0931-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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; |
Match all identifying details in the current notice. A brand name alone is not enough.
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;
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Dec 24, 2025
- Recall initiation date
- Oct 23, 2025
- Center classification date
- Dec 16, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.