Cardiosave Rescue
Reported: December 24, 2025 Initiated: October 23, 2025 #Z-0932-2026
Product Description
Cardiosave Rescue
Reason for Recall
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
Details
- Recalling Firm
- Datascope Corp.
- Units Affected
- 47 units (44 US, 3 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;
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
Cardiosave Rescue. Recalled by Datascope Corp.. Units affected: 47 units (44 US, 3 OUS).
Why was this product recalled? ▼
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 24, 2025. Severity: Low. Recall number: Z-0932-2026.
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