Datascope Corp. has recalled 160 units of the MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories (Model Number 0684-00-0295-01) due to discrepant labeling on the inner and outer packaging. The labeling on the packaging does not match, which may cause confusion regarding the device's specifications during use. There have been no reports of injuries or incidents related to this recall.
The inconsistent labeling on the device packaging could lead to medical professionals having incorrect information about the product during clinical procedures. This confusion could result in improper device selection or usage during critical care.
Recall #: Z-0311-2025
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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