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FDA-Device2025-12-17Class IIMISBRANDING

Datascope Cardiosave Hybrid intra-aortic balloon pump maintenance schedule update

Datascope
OTHERNationwide distribution

Check Cardiosave Hybrid maintenance schedule update

Datascope Corp. has updated the preventative maintenance schedule for Cardiosave Hybrid intra-aortic balloon pump systems to match changes made to the Service Manual in June 2023. Users should review the updated Instructions for Use (IFU) addendum to ensure proper maintenance timing.

  • Review the updated IFU addendum for your Cardiosave Hybrid model
  • Follow the revised preventative maintenance schedule
  • Contact Datascope or your service provider if you have questions about the updated schedule
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
11,470 units
Manufactured in
1300 Macarthur Blvd, N/A, Mahwah, NJ, United States
Products
Cardiosave Hybrid. Intra-Aortic Balloon Pump system.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0916-2026

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