Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP) Recalled by Datascope Corp. Due to The digital IFUs provided with the Cardiosave IABP...
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 Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
Quantity: 4 units
Why Was This Recalled?
The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.
Where Was This Sold?
International distribution in the country of Germany.
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