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Recall Observatory FDA recall evidence

Device product

Cardiosave Rescue

Z-0932-2026

October 23, 2025

Class III

Product summary

Firm
Datascope Corp.
Event
Event 97956
Status
Ongoing
Classification
Class III
Quantity
47 units (44 US, 3 OUS)
Official record key
device-enforcement:Z-0932-2026

Official wording

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

Code information: Model: 0998-00-0800-83; UDI-DI: 10607567108407; Serial Numbers: All;

Distribution pattern: 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;

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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