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FDA-Device2025-12-17Class IIMISBRANDING

Datascope Cardiosave Rescue intra-aortic balloon pump recalled for maintenance schedule update

Datascope
OTHERNationwide distribution

Check Datascope Cardiosave Rescue maintenance schedule

Datascope Corp. is updating the maintenance schedule for Cardiosave Rescue intra-aortic balloon pump systems to match changes made to the Service Manual in June 2023. This affects 47 units distributed worldwide. No injuries have been reported.

  • Review the updated Instructions for Use (IFU) addendum for your Cardiosave Rescue system
  • Update your preventative maintenance schedule to match the revised guidance
  • Contact Datascope Corp. if you have questions about the new maintenance requirements
Hazard

The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.

Sold states
Domestic: Nationwide Distribution; Foreign: Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia And Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, C¿te d Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Ghana, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Myanmar, 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, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Yemen, Zambia.
Affected count
47 units
Manufactured in
1300 Macarthur Blvd, N/A, Mahwah, NJ, United States
Products
Cardiosave Rescue. Intra-Aortic Balloon Pump system.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0917-2026

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