Class II
Medical Device Recall: CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
Maquet Medical Systems USA · April 15, 2024
Reason for Recall
The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.
Distribution
US Nationwide distribution in the states of NJ & TX.
States Affected
NATIONWIDE
Quantity Affected
148 units (US: 5; OUS: 143)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1831-2024
Status: ongoing
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