Skip to content

NA CARDIOHELP Holder for mast HKH 9102-M

by Maquet Cardiopulmonary AG

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

3 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04037691720791 UDI-DIDate29 Feb 2016ListedStatusListed GUDID: in commercial distribution

Recalls

10 recalls · 3 ongoing · FDA

    • Ongoing Z-1823-2025 FDA Class II initiated 30 Apr 2025

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

    • Ongoing Z-1662-2023 FDA Class II initiated 18 May 2023 on shared 510(k) K102726

    Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.

    • Ongoing Z-1643-2023 FDA Class II initiated 18 May 2023

    1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.

    • Terminated Z-0986-2019 FDA Class I initiated 8 Feb 2019

    Upon servicing the gearwheel in the Emergency Drive the gearwheel may have been re-assembled incorrectly, leading to the inadequate operation of the Emergency Drive.

    • Terminated Z-1642-2018 FDA Class II initiated 4 Apr 2018 on shared 510(k) K102726

    There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrations.

    • Terminated Z-1372-2016 FDA Class II initiated 23 Feb 2016

    Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.

    • Terminated Z-1690-2015 FDA Class II initiated 5 Mar 2015

    A potential issue was detected that could result in blood leakage from the gas outlet port in all lots of Quadrox-iD Adult Diffusion Membrane Oxygenator with Bioline and Softline Coatings, Custom Tubing Packs and Diffusion Membrane HLS Set Advanced and HIT Set Advanced Models.

    • Terminated Z-0211-2015 FDA Class II initiated 17 Oct 2014

    Cardiohelp- i System may have a software issue that can potentially result in an erroneous display of a "Battery Needs Service" message after startup of the units when using either AC or DC power

    • Terminated Z-0082-2014 FDA Class II initiated 12 Sep 2013

    It has come to the attention of MAQUET that in certain rare instances, the CARDIOHELP-i device may display an error message with audible alarm, indicating "battery defective." The alarm will occur-upon start up or when the main power supply is unplugged from the main power source. The human machine interface touch screen of the CARDIOHELP-i device may gradually become black due to the human machine interface (HMI) back light shutting down.

    • Terminated Z-1149-2013 FDA Class II initiated 7 Mar 2013

    It has come to the attention of MAQUET that there have been episodes of brief unexpected shutdown, followed by an automatic device restart of the human machine interface (touch screen) of the CARDIOHELP device. The human machine interface (HMI) is the central display of the CARDIOHELP device, where measured values, settings and alarms are displayed and adjusted/confirmed, with the exception of bl

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Medical device rail
Model / Ref / Catalog
CARDIOHELP Holder for mast HKH 9102-M, 70104.9584
Primary DI / UDI-DI
04037691720791
510(k) Number
FDA Product Code
DTQ
GMDN Term
Medical device rail
Device Class
Class II
Regulation Number
870.4220
GUDID distribution status
In Commercial Distribution

Related devices

Category: Medical device rail

Cleared under the same submission (K102726)

Other devices from Maquet Cardiopulmonary AG

See all devices from Maquet Cardiopulmonary AG →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No