AtriCure, Inc. is recalling 36 tank hose assemblies used with Cryo Module medical equipment because a supplier provided hoses with the wrong internal tubing material and an outer sheathing that lacks necessary pin perforations. These specific components are critical for the safe delivery of cryogenic gases during medical procedures. Approximately 35 units of the Cryo Module Accessories (A001053) and 1 unit of the Packaged Tank Hose Assembly (A001056) are affected by this defect. Consumers should immediately identify if their equipment is part of the affected lots and contact the manufacturer for further instructions.
The use of incorrect tubing materials and non-perforated sheathing can lead to component failure or the buildup of pressure during cryogenic medical procedures. This defect could potentially cause equipment malfunction or injury to patients or medical staff under certain operating conditions.
Contact manufacturer for instructions
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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