Medical device recalls Moderate risk

Maquet Cardiopulmonary Ag recalls Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital tra…

Recall date
April 30, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1823-2025
FDA classification
Class II
Brand / firm
Maquet Cardiopulmonary Ag
Sold / distributed
Domestic: IL & MO. Foreign: Australia, Austria, Belgium, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, India, Israel, Italy, Japan, South Korea, Poland, Russia, Saudi Arabia, Spain, Switzerland, Thailand.

Why it was recalled

HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.

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