Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Cardiosave Hybrid Recalled by Datascope Corp. Due to The IFU addendum updates the Vibration and Shock...
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
Quantity: 11470 units (5095 US, 6375 OUS)
Why Was This Recalled?
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
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