Z-1823-2025Class II

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

Name: Z-1823-2025 Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for...
Creator: Maquet Cardiopulmonary Ag
Published: 2025-04-30
License: https://open.fda.gov/license/

MAQUET CARDIOPULMONARY GmbH / initiated 2025-04-30 / Open, Classified

FDA source

Maquet Cardiopulmonary Ag began a recall of Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle on 2025-04-30. FDA classified it as Class II and gives the reason as "HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1823-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-30
Posted: 2025-05-27
Recalling firm: MAQUET CARDIOPULMONARY GmbH
Product: Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: US: 2 units; OUS: 168 units
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 codes and lots: Model No. 701045366; UDI 04037691456584; All Serial No.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1823-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1823-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-04	2025-05-27

Product code DTQ

K102726Class IICardiohelp SystemMaquet Cardiopulmonary, AG / cleared 2011-04-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)