Rastatt, N/A, Germany
Maquet Cardiopulmonary Ag recalls
3 recalls recorded since 2018, most recently on 30 April 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)1
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 30 April 2025
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1823-2025
- Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
Terminated Class II Medical devices
- Recall started
- 14 May 2018
- Terminated
- 15 May 2020
- Reason
- This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula.
- Distribution
- Worldwide distribution including US state of VA and Puerto Rico, Australia, Belgium, Brazil, Canada, Chile, Colombia, Cuba, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Iran, Ireland, Israel, Italy, Japan, Lebanon, Malaysia, Martinique, Mauritius, Mexico, Netherlands,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2160-2018, Z-2159-2018, Z-2161-2018
- Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002246, Article Number A22-7107. For use in cardiopulmonary bypass
- Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L); with 3/8-inch wide connector, Part Number 701002206, Article Number A20-0101. For use in cardiopulmonary bypass
- Aortic Arterial Cannula 24 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002267, Article Number A24-7107. For use in cardiopulmonary bypass
Terminated Class II Medical devices
- Recall started
- 4 April 2018
- Terminated
- 29 March 2019
- Reason
- There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrations.
- Distribution
- The product was distributed to the following US state: MO. The product was distributed to the following foreign countries: France, Germany, Switzerland, and Thailand.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1642-2018
- 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 CARDIOHELP System and required for inter-hospi
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.