Cardiohelp System HKH 8820 Wall Holder Recalled for Detachment Risk

Agency Publication Date: May 27, 2025

Summary

Maquet Cardiopulmonary Ag is recalling two HKH 8820 Wall Holders in the United States. These mounting brackets are designed to hold the Cardiohelp-i system during vehicle transport between hospitals. The holders do not meet specific safety standards and have the potential to detach from the wall while the vehicle is in motion. No injuries or incidents have been reported to date.

Risk

The mounting bracket can fail to securely hold the life-support equipment, causing it to fall or detach during transport. This poses a risk of equipment damage or a dangerous interruption of critical patient care while a vehicle is moving.

What You Should Do

This recall involves the Cardiohelp System HKH 8820 Wall Holder, which is a mounting bracket used to hold the Cardiohelp-i system for interhospital transport by vehicle.
The recalled products are identified by Model Number 701045366 and UDI 04037691456584. All serial numbers for this model are affected by the recall.
Stop using the recalled device immediately. Contact Maquet Cardiopulmonary Ag or your authorized medical device distributor to arrange for a return, replacement, or correction of the wall holder.
Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional questions regarding this recall.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Cardiohelp System HKH 8820 Wall Holder

Model / REF:

701045366

Serial Numbers:

All Serial No.

UDI:

04037691456584

Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96820

Status: Active

Manufacturer: Maquet Cardiopulmonary Ag

Sold By: Authorized medical device distributors

Manufactured In: Germany

Units Affected: US: 2 units; OUS: 168 units

Distributed To: Illinois, Missouri

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves the Cardiohelp System HKH 8820 Wall Holder, which is a mounting bracket used to hold the Cardiohelp-i system for interhospital transport by vehicle.

The recalled products are identified by Model Number 701045366 and UDI 04037691456584. All serial numbers for this model are affected by the recall.

Stop using the recalled device immediately. Contact Maquet Cardiopulmonary Ag or your authorized medical device distributor to arrange for a return, replacement, or correction of the wall holder.

Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional questions regarding this recall.