Cardiosave Hybrid. Intra-Aortic Balloon Pump system.
Reported: December 17, 2025 Initiated: November 4, 2025 #Z-0916-2026
Product Description
Cardiosave Hybrid. Intra-Aortic Balloon Pump system.
Reason for Recall
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Details
- Recalling Firm
- Datascope Corp.
- Units Affected
- 11,470 units
- Distribution
- 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.
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
Cardiosave Hybrid. Intra-Aortic Balloon Pump system.. Recalled by Datascope Corp.. Units affected: 11,470 units.
Why was this product recalled? ▼
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 17, 2025. Severity: Moderate. Recall number: Z-0916-2026.
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