--- title: "CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOH... — FDA record Z-0420-2024 | Is It on Recall" description: "Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This issue can lead to the patient being exposed to inappropriate low" url: https://isitonrecall.com/recall/fda-device-z-0420-2024-cardiohelp-emergency-drive-part-numbers-701048002-and-701076205-the-cardiohelp-system-is-a-blood-oxy/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and ca... — FDA record Z-0420-2024 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Oct 10, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system. - **Reason**: Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This issue can lead to the patient being exposed to inappropriate low blood flow. Potential associated harms are ischemia and hypoxia. - **Classification**: Class I - **Recalling firm**: Maquet Medical Systems USA - **Quantity**: Updated 1/8/24 - 1858 Total distributed in U.S.; 69 Total affected units in U.S. - **Agency-reported status**: Ongoing - **Source record identifier**: Z-0420-2024 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0420-2024%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | Part No. 701048002: UDI - 04037691643526; Serial Numbers 90425259 to 90425748 (Excluding 90425438, 90425443, 90425568, 90425570, 90425588, 90425716) [\*\*\*Updated 1/8/24 to include Serial numbers 90421507, 90421980, 90424277. Serial numbers 90425366 and 90423121 are additionally included in the scope due to internal complaints, but these units were corrected prior to the field action initiation and therefore are not included in customer notification\*\*\*] Part No. 701076205: No UDI; Serial Numbers 90425438, 90425443, 90425568, 90425570, 90425588, 90425716, 90425747, 90425748 | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution US Nationwide - Worldwide Distribution: Domestic distribution to: AL, CA, DC, FL, HI, IA, IL, IN, KY, MD, MI, MN, MO, NE, OH, SC, VA Foreign distribution to: Austria, Australia, Brazil, Canada, Chile, China, Czech Republic, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Jordan, Mexico, New Zealand, Pakistan, Portugal, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom States below are derived from the distribution text, including nationwide wording. 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These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0420-2024%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Maquet Medical Systems USA records](https://isitonrecall.com/brand/maquet-medical-systems-usa/)