Cardiosave Rescue
Enforcement
- Recall Number
- Z-0932-2026
- Event ID
- 97956
- Classification
- Class III
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Datascope Corp.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 24, 2025
- Initiation Date
- October 23, 2025
- Classification Date
- December 16, 2025
- Address
- 1300 Macarthur Blvd, Mahwah, NJ, 07430-2052, United States
Description
Cardiosave Rescue
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
Model: 0998-00-0800-83; UDI-DI: 10607567108407; Serial Numbers: All;
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;
47 units (44 US, 3 OUS)