Datascope Corp. has recalled 18,758 units of the Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP) due to a recurring hardware failure. The issue occurs when the fiber optic connector is inserted into the pump, which can cause the IAB fiber optic sensor input to fail. If this occurs, the device may lose certain monitoring capabilities during critical cardiac support. Consumers should contact their healthcare provider or the manufacturer for further instructions regarding this equipment defect.
A failure in the fiber optic sensor input can prevent the pump from receiving necessary pressure data from the balloon, potentially leading to a delay or interruption in therapy for patients requiring circulatory support.
Manufacturer correction/instruction following sensor failure reports.
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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