Datascope Corp. has recalled approximately 11,517 Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump systems to update their Instructions for Use. This recall was initiated to align the devices' preventative maintenance schedule with an updated Service Manual released in June 2023. These systems are used in hospitals to provide life-saving cardiac support to patients.
The recall addresses a documentation discrepancy regarding the preventative maintenance schedule. If the devices are not maintained according to the most current schedule, there is a potential for reduced device performance or unexpected failure during critical patient care. No injuries have been reported in connection with this update.
Instruction for Use (IFU) addendum revises the Preventative Maintenance schedule.
Instruction for Use (IFU) addendum revises the Preventative Maintenance schedule.
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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