Datascope Corp. is recalling approximately 10,897 CS100 and CS300 Intra-Aortic Balloon Pumps (IABP) because the Instructions for Use (IFU) contain outdated battery runtime and cycle specifications. This issue affects devices using Software Versions Q.01 (CS100) and C.01 (CS300) manufactured in the United States. The firm is initiating this voluntary recall to ensure medical staff have accurate information regarding the battery's expected performance and lifespan during clinical use.
Incorrect battery runtime and cycle information can lead to unexpected device shutdown if the battery exhausts its power sooner than the clinician anticipates based on the manual. This could cause a sudden interruption in cardiac support therapy, which may lead to serious health consequences for patients requiring hemodynamic stability.
Recall #: Z-1486-2026. Quantity: 10,897 units.
Recall #: Z-1487-2026. Quantity: 10,897 units.
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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