medical Class I Updated 2023-12-13

Maquet Medical Systems USA recalls CARDIOHELP Emergency Drive, Part Numbers 701048002 and 70107

Recalled Product

CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: 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

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