Cardiohelp System HKH 8820 Wall Holder Mounting Bracket Recall
The Cardiohelp System HKH 8820 Wall Holder, a mounting bracket for the CARDIOHELP-i system used in interhospital transport, does not comply with standard DIN EN 1789:20 and may detach during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The source indicates an FDA Class II recall with a non-compliance issue (failure to meet safety standard DIN EN 1789:20) and potential for detachment of a mounting bracket used in critical patient transport. No reported illnesses or injuries are mentioned, but this is a risk-of-harm product where injury has not yet been reported, meeting the High (score 3) threshold.
Plain-English summary
Maquet Cardiopulmonary Ag is recalling the Cardiohelp System HKH 8820 Wall Holder (Model No. 701045366, UDI 04037691456584, all serial numbers). This mounting bracket is designed to hold the CARDIOHELP-i system during interhospital transport by vehicle.
The wall holder does not comply with standard DIN EN 1789:20 and has the potential to detach. This non-compliance poses a risk during transport of critical cardiopulmonary support equipment.
Two units were distributed in the United States (Illinois and Missouri). An additional 168 units were distributed internationally to 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, and Thailand.
Customers who have received this product should contact Maquet Cardiopulmonary Ag or their local distributor for instructions on inspection, replacement, or return of the wall holder.
The recalled product
- Product
- Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
- Manufacturer
- Maquet Cardiopulmonary Ag
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No. 701045366
- UDI 04037691456584
- All Serial No.
Distribution
Related recalls
Same manufacturer · Maquet Cardiopulmonary Ag
See all →- HighMaquet Aortic Arterial Cannula Recall Due to De-airing Plug Defect
FDA (Devices) · 2018-06-20
- HighMaquet Aortic Arterial Cannula Recall Due to De-airing Plug Breakage Risk
FDA (Devices) · 2018-06-20
- SevereMaquet Aortic Arterial Cannula Recalled for De-airing Plug Breakage Risk
FDA (Devices) · 2018-06-20
- HighMaquet Cardiohelp Gas Bottle Holder Recalled for Potential Clamp Failure
FDA (Devices) · 2018-05-16
Same hazard · equipment detachment
See all →- HighHip Traction Boot Assembly Defect Could Cause Device Detachment
FDA (Devices) · 2024-03-27
- HighAltec Welder Equipment May Detach From Aerial Device Vehicles
NHTSA · 2023-12-07
- HighNova Bus LFS Transit Buses Recalled for HVAC Unit Bracket Failure
NHTSA · 2023-11-11
- HighOEC Flexiview 8800 Image Intensifier Risks Detachment During Movement
FDA (Devices) · 2023-08-09
- HighImage intensifier detachment hazard in OEC fluoroscopy imaging systems
FDA (Devices) · 2023-08-09
Similar recalls
- HighMaquet Cardiohelp Gas Bottle Holder Recalled for Potential Clamp Failure
FDA (Devices) · 2018-05-16
- HighCardiohelp-i Transport Guard Pin Defect May Prevent Device Opening
FDA (Devices) · 2022-04-13
- ModerateCARDIOHELP-i Heart-Lung Support System not properly tested for leakage current
FDA (Devices) · 2023-12-27
- HighCARDIOHELP-i Heart-Lung Support System: Incorrectly Documented Factory Settings
FDA (Devices) · 2023-12-20
- HighMaquet Cardiohelp Support System Recalled for Unexpected Shutdowns
FDA (Devices) · 2013-04-24
- HighCARDIOHELP-i System Recalled for Elevated Patient Leakage Current
FDA (Devices) · 2024-05-22