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 (IABP) Recalled by Datascope Corp. Due to The Helium Indicator on the Cardiosave display may...
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 (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65
Quantity: 5054 total (US), 5033 total (OUS)
Why Was This Recalled?
The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.
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