medical Class III Updated 2023-12-27

Maquet Medical Systems USA recalls CARDIOHELP-i Heart Lung Support System: Blood oxygenation an

Recalled Product

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


Hazard / Issue

CARDIOHELP-i System was not properly tested to measure leakage current

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 04058863074863; 04037691658384 All serial numbers up to and including 90415172
View official government recall

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