Cardiohelp System HKH 8820 Wall Holder. Mounting bracket… recallZ-1823-2025 · Maquet Cardiopulmonary Ag · initiated Apr 30, 2025
Class II Open, Classified All recalls posted in May 2025
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Maquet Cardiopulmonary Ag or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.
FDA root cause category: Under Investigation by firm
What the company is doing
An URGENT MEDICAL DEVICE RECALL (REMOVAL) notification dated April 2025 was mailed to consignees. The notification instructs consignees to identify and quarantine all affected product. Consignees should forward the provided recall notification to any individuals within their organization that utilize the affected device or to the entity it was distributed to. Consignees should complete and return the provided response form by email to [email protected]. Getinge Customer Service can be contacted at 888-943-8872 option 2 or by email at [email protected] to coordinate return of affected devices.
Recall details
- Recall number
- Z-1823-2025
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Apr 30, 2025
- Posted by the FDA
- May 27, 2025
- Recalling firm
- Maquet Cardiopulmonary Ag
- Quantity
- US: 2 units; OUS: 168 units
- Product code
- DTQ
- FDA submissions
- K102726
- 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.
Product description
Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
Code information (models, lots, serial numbers)
Model No. 701045366; UDI 04037691456584; All Serial No.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NA Wall holder HKH 8820Maquet Cardiopulmonary AG · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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