Maquet Medical Systems USA recalls CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through…

Recall date

November 14, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0595-2024

FDA classification

Class III

Brand / firm

Maquet Medical Systems USA

Sold / distributed

Nationwide-WW Distribution to Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, French Polynesia, Germany, Ghana, Greece, Hong Kong,…

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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