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Datascope Corp.: Cardiosave Hybrid. Intra-Aortic Balloon Pump system.

Medical DevicesSource: FDA (device) · Date: 2025-12-17

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Datascope Corp.
Product
Cardiosave Hybrid. Intra-Aortic Balloon Pump system.
Reason / hazard
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2025-11-04
Code info
Model No. (UDI): D998-00-0800-31 (10607567109053), D998-00-0800-32 (10607567111117), D998-00-0800-33 (10607567109008), D998-00-0800-35 (10607567109107), D998-00-0800-36 (10607567114187), D998-00-0800-45 (10607567108421), D998-00-0800-52 (10607567108438), D998-00-0800-53 (10607567108391), D998-00-0800-55 (10607567108414), D998-00-0800-65 (10607567113432), D998-UC-0800-31 (10607567109053), D998-UC-0800-33 (10607567109008), D998-UC-0800-52 (10607567108438), D998-UC-0800-53 (10607567108391), D998-UC-0800-55 (10607567108414); ALL SERIAL NO.
Product quantity
11,470 units
Voluntary mandated
Voluntary: Firm initiated
City
Mahwah
State
NJ
Country
United States
Event id
97946
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