Maquet Medical Systems USA is recalling approximately 1,213 venous probe connection cables used with the Cardiohelp-i System due to reports of broken insulation, shielding, or wires within the cable. These fractures can prevent the system from receiving critical data from the venous probe, which is used during extracorporeal life support. If the cable fails, the patient may be exposed to incorrect blood flow, improper blood temperatures, or inaccurate hemoglobin and hematocrit levels. Consumers using these systems should contact the manufacturer or their healthcare provider for specific guidance on managing affected equipment.
A fractured cable causes a loss of communication between the probe and the Cardiohelp-i System, leading to potential mismanagement of life-sustaining extracorporeal support. This could result in critical errors regarding blood flow regulation or temperature management, posing a significant risk to patients in clinical settings.
Manufacturer notification and guidance
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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