Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system. Recalled by Maquet Medical Systems USA Due to The firm identified that the measured patient leakage...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Maquet Medical Systems USA directly.
Affected Products
CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
Quantity: 148 units (US: 5; OUS: 143)
Why Was This Recalled?
The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Maquet Medical Systems USA
Maquet Medical Systems USA has 40 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report