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Model note · Cardiopulmonary Bypass

Maquet HL 20 heart-lung machine

The HL 20 is Getinge's modular roller pump heart-lung machine, sold under the Jostra and then Maquet names, which drives, controls and monitors extracorporeal circulation. During bypass the HL 20 does the heart's pumping while a disposable oxygenator handles gas exchange. It sits on a console holding four or five roller pumps, with mast mounted accessories. Public technical data are sparse, so this note leans on FDA recall and device identifier records.

The model

Maker, model and type.

Maker
Maquet Cardiopulmonary AG (Getinge; originally Jostra)
Model
Maquet HL 20 heart-lung machine (4 pump console P/N 917741, 5 pump console P/N 917751)
Device type
Cardiopulmonary Bypass
Main document
Open the public document

Key specifications

What the public record says.

ItemValueSource
FDA product code and clearanceDTQ, cardiopulmonary bypass heart-lung machine console; premarket submission K943803 (Jostra HL-20 Integrated Perfusion System, decided 30 January 1996)Source
Indication (from FDA recall record)Extracorporeal circulation for perfusion lasting not more than six hoursSource
Console bases4 pump console P/N 917741; 5 pump console P/N 917751Source
Roller pumpRPM 20 roller pump; RPM 20-230 accepts single tube inserts such as STI 1/2 x 1/16 inch (catalogue 701020800)Source
Pump head guidanceFour pairs of tube guide rolls hold the tube in the raceway as the head turnsSource
Mast accessories (GUDID)VEM 20-119 vertical mast short (701020742); extended mast system (701043271)Source
Emergency manual operationRoller pumps have a hand crank for emergency manual rotationSource

Recalls

Known FDA recalls.

  • Z-3084-20112011-06-20

    Twin pump modules could briefly increase speed unintentionally.

    FDA record
  • Z-3057-20112011-06-20

    4 and 5 pump consoles could malfunction from circuit board exposure to excess liquid.

    FDA record
  • Z-1394-20112010-09-28

    Wrong ball bearing in RPM 20 pump heads could cause wear and loss of function.

    FDA record
  • Z-0159-20072006-10-03

    Dirt in tube guide rolls could make them stick.

    FDA record
  • Z-0158-20072006-09-01

    Emergency hand cranks too wide to fit their pump head holes.

    FDA record

Safety

Safety warnings from the record.

  • Twin pump modules could raise speed unintentionally for 1.5 to 2 seconds before returning to the set value. Source
  • A hand crank that does not fit leaves no manual backup if a pump fails during bypass. Source
  • Using too much liquid when cleaning the console can cause it to malfunction. Source

Sources

Where this note comes from.

Not covered: Sources are thin. The HL 20 510(k) summary (K943803, 1996) is not online, Getinge's product page no longer shows HL 20 detail, and the user manuals found online sit on a third party site that refused access, so flow ranges, battery backup time, sensors, electrical ratings and alarm messages are not included. No error codes were found in an opened public document. Recalls are mostly from 2006 to 2011; newer field actions may exist under other names such as HL 40. Recall text was read through openFDA because FDA recall pages returned errors at drafting time.

BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.