Datascope Corp. is recalling approximately 18,350 Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) because the devices may trigger false 'Gas Loss' or 'Gas Gain' alarms during therapy. These alarms, which can cause the pump to stop unexpectedly, were found to be triggered by common patient movements such as coughing, swallowing, or general movement, as well as blood in the circuit or hardware issues. If you or a family member are using one of these life-supporting devices, please contact your healthcare provider or the manufacturer immediately to ensure the device is functioning correctly and to discuss alternative care if necessary.
The device may unexpectedly stop providing critical cardiac support due to false alarms triggered by routine patient movements or hardware malfunctions. This interruption in therapy can lead to serious health complications, including unstable blood flow or organ damage, particularly for patients in critical condition.
Information update and technical review
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
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.