Datascope Corp. is recalling approximately 10,950 units of the Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP) due to software-related issues. The recall covers 5,475 Hybrid units and 5,475 Rescue units distributed internationally. The company has developed a software update (Revision D.01) to fix defects that can cause the pumps to stop working or fail to transmit clinical data correctly. This recall affects all lots of specific model numbers used to help the heart pump blood.
The software defects can cause the medical device to stop providing mechanical circulatory support, leading to hemodynamic instability where the heart cannot pump enough blood to the body. This failure, along with potential transmission errors of clinical data, poses a critical risk of serious injury or death to patients relying on the device for cardiac support.
You have 2 options:
Software correction (Revision D.01)
Manufacturer consultation
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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