Class II

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

Maquet Cardiopulmonary Ag · April 30, 2025

Reason for Recall

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

Distribution

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.

States Affected

IL, MO

Quantity Affected

US: 2 units; OUS: 168 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1823-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Maquet Cardiopulmonary Ag Medical Device Recall: Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle. | SafeCheck