Maquet Cardiopulmonary Ag: Medical Device Recall in 2025 - (Recall #: Z-1823-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 30, 2025

Date Posted: June 4, 2025

Recall Number: Z-1823-2025

Event ID: 96820

Reason for Recall:

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

Status: Ongoing

Product Quantity: US: 2 units; OUS: 168 units

Code Information:

Model No. 701045366; UDI 04037691456584; All Serial No.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated