NA Wall holder HKH 8820Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

9 other recalls cover devices cleared under the same FDA submission (K102726); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Apr 30, 2025Class IIOpen, Classified

   HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.

   Z-1823-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102726. One submission often covers many models, so check the product and lot details in each record.

• Z-1643-2023 · May 18, 2023 · Open, Classified
  QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, wit
• Z-1662-2023 · May 18, 2023 · Open, Classified
  QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult wi
• Z-0986-2019 · Feb 8, 2019 · Terminated
  Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the Cardiohelp-i fails.
• Z-1642-2018 · Apr 4, 2018 · Terminated
  CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901 Product Usage: The Cardiohelp Gas Bottle (or Cylinder) Holder HKH 8880 is an accessory for the CARDIOHEL
• Z-1372-2016 · Feb 23, 2016 · Terminated
  HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator
• Z-1690-2015 · Mar 5, 2015 · Terminated
  HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Product Usage: HLS/HIT Set Advanced: The CARDIO HELP System in configuration with the HLS/HIT Set Advanced is in
• Z-0211-2015 · Oct 17, 2014 · Terminated
  Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal bypass circuit for circulatory and/or pul
• Z-0082-2014 · Sep 12, 2013 · Terminated
  MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Made in Germany. Cardiopulmonary support system.
• Z-1149-2013 · Mar 7, 2013 · Terminated
  MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp System is a blood oxygenation and carbon dioxide removal system use