Datascope Corp. is recalling approximately 10,950 Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps due to a software defect that requires a correction (Revision D.00). These devices are electromechanical systems used to inflate and deflate balloons inside the aorta to assist the heart. The recall was initiated because the devices may experience hemodynamic instability or fail to transmit clinical data, which can compromise patient care. Affected units were manufactured in the United States and distributed internationally to dozens of countries.
The software defect poses a risk of sudden hemodynamic instability, which means the heart may not be able to pump enough blood to the rest of the body. Additionally, the failure to transmit clinical data prevents medical staff from receiving critical information needed to monitor the patient's condition.
You have 2 options:
Software Correction Revision D.00
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.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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
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