Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital tran
Summary
The FDA issued a Class II for Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CA by Maquet Cardiopulmonary Ag. Reason: HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach..
Details
Source
Device Recall
External ID
Z-1823-2025
Action Date
2025-06-04
Status
Ongoing
Category
device
Product Description
Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
Lot/Code Info: Model No. 701045366; UDI 04037691456584; All Serial No.
Quantity Affected: US: 2 units; OUS: 168 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-30
Company
Rastatt, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 185 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Maquet Cardiopulmonary Ag) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Maquet Cardiopulmonary Ag have FDA actions?
This is the only FDA action we have on record for Maquet Cardiopulmonary Ag in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1823-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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