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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device

Datascope Corp.: 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.

Agency Publication Date: March 9, 2023
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Affected Products

Product: 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

All serial numbers. Model 0998-00-0800-31, UDI-DI 10607567109053; Model 0998-00-0800-32, UDI-DI 10607567111117; Model 0998-00-0800-33, UDI-DI 10607567109008; Model 0998-00-0800-34, UDI-DI 10607567111940; Model 0998-00-0800-35, UDI-DI 10607567109107; Model 0998-00-0800-45, UDI-DI 10607567108421; Model 0998-00-0800-52, UDI-DI 10607567108438; Model 0998-00-0800-53, UDI-DI 10607567108391; Model 0998-00-0800-55, UDI-DI 10607567108414; Model 0998-00-0800-65, UDI-DI 10607567113432

Product: Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

All serial numbers. Model Number 0998-00-0800-75, UDI-DI 10607567112312; Model Number 0998-00-0800-83, UDI-DI 10607567108407; Model Number 0998-00-0800-85, UDI-DI 10607567113449

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91602
Status: Active
Manufacturer: Datascope Corp.
Manufactured In: United States
Units Affected: 2 products (4062 Total)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.