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 Cardiosave IABP may unexpectedly shut down when...
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: 3969 total (US), 3550 total (OUS)
Why Was This Recalled?
The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. This occurs during a very specific set of conditions.
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