FDA-Device2025-12-24Class IIIMISBRANDING
Datascope Cardiosave Hybrid recalled for IFU documentation update
What this means
Datascope Corp. is updating the instruction manual for Cardiosave Hybrid devices to correct references in the Vibration and Shock Table to ensure alignment with applicable standards. This is a documentation correction that affects multiple device models.
- Locate your device model number (begins with 0998-00 or 0998-UC)
- Contact Datascope Corp. or your distributor for the updated instruction manual
- Replace your current manual with the corrected version once received
The agency's original wording
Hazard
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
Intended for
Adults
Illnesses reported
None reported
Sold states
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;
Affected count
11470 units (5095 US, 6375 OUS)
Manufactured in
1300 Macarthur Blvd, Mahwah, NJ, United States
Products
Cardiosave Hybrid
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0931-2026Want us to check the next one for you?
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