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Recall Observatory FDA recall evidence

Device product

Cardiosave Rescue. Intra-Aortic Balloon Pump system.

Z-0917-2026

November 04, 2025

Class II

Product summary

Firm
Datascope Corp.
Event
Event 97946
Status
Ongoing
Classification
Class II
Quantity
47 units
Official record key
device-enforcement:Z-0917-2026

Official wording

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

Code information: Model No. (UDI): 0998-00-0800-83 (10607567108407); ALL SERIAL NO.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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