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Z-0931-2026Class III

Datascope Corp.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Datascope Corp.
Product type
Device
Status
Ongoing
Report date
2025-12-24
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
Firm state
NJ
Product quantity
11470 units (5095 US, 6375 OUS)
Initiated by
Voluntary: Firm initiated
Reason for recall

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

Product description

Cardiosave Hybrid

Code / lot info

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;

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →