Maquet Medical Systems USA is recalling 1,594 units of the CARDIOHELP-i Heart Lung Support System because the devices were not properly tested for electrical leakage current during manufacturing. This system is a critical medical device used to pump and oxygenate a patient's blood during circulatory or pulmonary support for up to six hours. The affected units include those with product reference numbers 701072780 and 701048012, specifically all serial numbers up to and including 90415172. While this is a voluntary recall initiated by the firm, it is important to verify if your equipment is among the affected units distributed globally and nationwide in the United States.
The failure to properly test for leakage current means the device could potentially expose patients or healthcare providers to unintended electrical currents. This poses a risk of electrical shock or interference with other medical equipment during critical heart-lung support procedures.
Manufacturer consultation and potential refund/repair
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.