Maquet Medical Systems USA has recalled 1,022 units of the Cardiohelp-i blood oxygenation and carbon dioxide removal system and associated Slide Rail Holders. It was discovered that the weld used to attach the nut bolt to the slide rail plate is insufficient and can break off with slight manual force. Consumers and healthcare providers should be aware that this defect affects specific serial numbers of the Cardiohelp-i system and the accompanying slide rail equipment.
A broken nut bolt can cause the slide rail plate or attached components to become unstable or detached, potentially interrupting critical blood oxygenation or carbon dioxide removal therapy. This failure could lead to serious medical complications for patients relying on the device for life-sustaining respiratory or circulatory support.
Manufacturer Notification and Correction
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.