Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP) Recalled by Datascope Corp. Due to An unexpected shutdown of the IABP may occur...
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), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 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, 0998-UC-0800-31, 0998-UC-0800-33, 0998-UC-0800-52, 0998-UC-0800-53, 0998-00-0800-55
Quantity: 4062 Total
Why Was This Recalled?
An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coiled Cord cable and the Cable Assembly backplane to the Coiled Cord cable which provides the communication between the display head and base unit.
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