Maquet Medical Systems USA is recalling 69 affected units of the CARDIOHELP Emergency Drive (Part Numbers 701048002 and 701076205) due to a defect that can cause the drive to become blocked or impaired. This emergency drive is part of the CARDIOHELP System, which is used to oxygenate blood and remove carbon dioxide for patients. If the emergency drive fails to function correctly, the patient may receive dangerously low blood flow, which can lead to serious health complications like tissue damage or lack of oxygen to vital organs.
The mechanical failure of the emergency drive can cause it to stop or operate poorly, preventing the necessary circulation of blood and oxygen. This lack of circulation poses a critical risk of ischemia (restricted blood supply) and hypoxia (insufficient oxygen levels) to the patient's body.
Product removal and field action
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.
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Sources: FDA iRES · Raw API Response
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