Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide Recalled by Maquet Medical Systems USA Due to CARDIOHELP-i System was not properly tested to measure...
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 Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). Product REF Numbers: 701072780; 701048012
Quantity: 1594 units
Why Was This Recalled?
CARDIOHELP-i System was not properly tested to measure leakage current
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