Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cardiosave Hybrid. Intra-Aortic Balloon Pump system. Recalled by Datascope Corp. Due to The IFU addendum revises the Preventative Maintenance schedule...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Datascope Corp. directly.
Affected Products
Cardiosave Hybrid. Intra-Aortic Balloon Pump system.
Quantity: 11,470 units
Why Was This Recalled?
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Datascope Corp.
Datascope Corp. has 66 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report