Maquet Medical Systems USA is recalling 274 units of the Bubble Sensor, an optional accessory used with the CARDIOHELP-i extracorporeal life support system, because the devices were shipped with an incorrect Universal Device Identifier (UDI) on the label. This recall affects approximately 70 units in the United States and 204 units internationally that were distributed in several states including California, Texas, and Florida. While the sensor itself functions correctly, the incorrect identification label could lead to confusion during device tracking or maintenance.
The use of an incorrect device identifier can cause errors in medical record-keeping and device tracking, which may complicate equipment maintenance or the ability to identify specific units during future safety updates.
Label correction and contact 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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