Terumo Advanced Perfusion System 1Recalls & reported problems across all models

We found 31 models of Terumo Advanced Perfusion System 1 by Terumo Cardiovascular Systems Corporation in the FDA's device registry (GUDID). Together they are named in 1,869 adverse event reports in the FDA's MAUDE database, received between May 18, 2018 and Sep 29, 2026 — classified as 2 deaths, 1 injury, 1,866 malfunctions.

The most frequently reported specific device problem is “Output Problem” (509 reports).

11 FDA recall records name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Terumo Advanced Perfusion System 1 recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 8, 2021Terminated

   intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up period. The control sliders on the Central Control Monitor (CCM) are disabled and the gas system can only be controlled by the local control knobs

   Z-2350-2021 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Aug 25, 2020Terminated

   Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the mating wire connector. This intermittent connection may result in false air bubble alarms.

   Z-2961-2020 · Root cause: Employee error · Recall details · FDA record ↗

3. Aug 25, 2020Terminated

   Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the mating wire connector. This intermittent connection may result in false air bubble alarms.

   Z-2960-2020 · Root cause: Employee error · Recall details · FDA record ↗

4. Aug 25, 2020Terminated

   Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the mating wire connector. This intermittent connection may result in false air bubble alarms.

   Z-2959-2020 · Root cause: Employee error · Recall details · FDA record ↗

5. Jan 10, 2020Terminated

   These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a noise that is atypical of roller pump operation. The noise is caused when an unsecured shaft end contacts the rotating pulley of the roller pump. Prolonged use of a roller pump in this condition could lead to an eventual pump stop, resulting in the inability to create pump flow due to pulley loosening and drive belt damage.

   Z-1109-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

6. Jan 10, 2020Terminated

   These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a noise that is atypical of roller pump operation. The noise is caused when an unsecured shaft end contacts the rotating pulley of the roller pump. Prolonged use of a roller pump in this condition could lead to an eventual pump stop, resulting in the inability to create pump flow due to pulley loosening and drive belt damage.

   Z-1108-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

7. Oct 17, 2018Terminated

   An intermittent failure which causes a blender initialization fault upon start-up or during an EPGS calibration attempt leads to the Central Control Monitor control sliders being disabled, such that the gas system can only be controlled by the local control knobs.

   Z-1769-2019 · Root cause: Process control · Recall details · FDA record ↗

8. Sep 13, 2018Terminated

   The service manual was not updated at the time of the release of software version 1.30.

   Z-0176-2019 · Root cause: Error in labeling · Recall details · FDA record ↗

9. Jan 19, 2018Terminated

   Inaccurrate flow readings. Depending on the degree of inaccuracy, this issue may not be easy for the user to detect during setup or use (for example, following a Flow Probe relocation or manipulation).

   Z-1478-2018 · Root cause: Employee error · Recall details · FDA record ↗

10. Feb 20, 2017Terminated

    Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads due to non-compliant labeling because the product expiration date is displayed in a format that may not be recognizable to all users.

    Z-1459-2017 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

11. Feb 20, 2017Terminated

    Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads due to non-compliant labeling because the product expiration date is displayed in a format that may not be recognizable to all users.

    Z-1458-2017 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Terumo Advanced Perfusion System 1 problems

Terumo Advanced Perfusion System 1 models

31 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Terumo® Advanced Perfusion System 1 801188

  Console, Heart-Lung Machine, Cardiopulmonary Bypass
  3 recalls447 reports
• Terumo® Advanced Perfusion System 1 816300

  Console, Heart-Lung Machine, Cardiopulmonary Bypass
  300 reports
• Terumo® Advanced Perfusion System 1 801763

  Console, Heart-Lung Machine, Cardiopulmonary Bypass
  1 death230 reports
• Terumo® Advanced Perfusion System 1 816571

  Console, Heart-Lung Machine, Cardiopulmonary Bypass
  230 reports
• Terumo® Advanced Perfusion System 1 5773

  Console, Heart-Lung Machine, Cardiopulmonary Bypass
  1 recall78 reports
• Terumo® Advanced Perfusion System 1 801040

  Console, Heart-Lung Machine, Cardiopulmonary Bypass
  2 recalls0 reports
• Terumo® Advanced Perfusion System 1 802018

  Pump, Blood, Cardiopulmonary Bypass, Roller Type
  1 recall1 death46 reports
• Terumo® Advanced Perfusion System 1 816570

  Console, Heart-Lung Machine, Cardiopulmonary Bypass
  87 reports
• Terumo® Advanced Perfusion System 1 816572

  Console, Heart-Lung Machine, Cardiopulmonary Bypass
  73 reports
• Terumo® Advanced Perfusion System 1 195240

  Console, Heart-Lung Machine, Cardiopulmonary Bypass
  1 recall20 reports
• Terumo® Advanced Perfusion System 1 195215

  Console, Heart-Lung Machine, Cardiopulmonary Bypass
  68 reports
• Terumo® Advanced Perfusion System 1 6382

  Console, Heart-Lung Machine, Cardiopulmonary Bypass
  60 reports
• Terumo® Advanced Perfusion System 1 5785

  Console, Heart-Lung Machine, Cardiopulmonary Bypass
  1 recall2 reports
• Terumo® Advanced Perfusion System 1 5791

  Console, Heart-Lung Machine, Cardiopulmonary Bypass
  1 recall0 reports
• Terumo® Advanced Perfusion System 1 217390

  Console, Heart-Lung Machine, Cardiopulmonary Bypass
  1 recall0 reports
• Terumo® Advanced Perfusion System 1 195274

  Console, Heart-Lung Machine, Cardiopulmonary Bypass
  44 reports
• Terumo® Advanced Perfusion System 1 164267

  Console, Heart-Lung Machine, Cardiopulmonary Bypass
  31 reports
• Terumo® Advanced Perfusion System 1 802111

  Console, Heart-Lung Machine, Cardiopulmonary Bypass
  30 reports
• Terumo® Advanced Perfusion System 1 802114

  Pump, Blood, Cardiopulmonary Bypass, Roller Type
  23 reports
• Terumo® Advanced Perfusion System 1 806455

  Pump, Blood, Cardiopulmonary Bypass, Roller Type
  23 reports
• Terumo® Advanced Perfusion System 1 801764

  Console, Heart-Lung Machine, Cardiopulmonary Bypass
  22 reports
• Terumo® Advanced Perfusion System 1 803480

  Pump, Blood, Cardiopulmonary Bypass, Roller Type
  14 reports
• Terumo® Advanced Perfusion System 1 890500

  Console, Heart-Lung Machine, Cardiopulmonary Bypass
  14 reports
• Terumo® Advanced Perfusion System 1 802112

  Pump, Blood, Cardiopulmonary Bypass, Roller Type
  12 reports
• Terumo® Advanced Perfusion System 1 802110

  Console, Heart-Lung Machine, Cardiopulmonary Bypass
  6 reports
• Terumo® Advanced Perfusion System 1 164268

  Console, Heart-Lung Machine, Cardiopulmonary Bypass
  3 reports
• Terumo® Advanced Perfusion System 1 801041

  Console, Heart-Lung Machine, Cardiopulmonary Bypass
  2 reports
• Terumo® Advanced Perfusion System 1 149673

  Console, Heart-Lung Machine, Cardiopulmonary Bypass
  1 report
• Terumo® Advanced Perfusion System 1 802100

  Console, Heart-Lung Machine, Cardiopulmonary Bypass
  1 report
• Terumo® Advanced Perfusion System 1 884660

  Console, Heart-Lung Machine, Cardiopulmonary Bypass
  1 report
• Terumo® Advanced Perfusion System 1 893607

  Console, Heart-Lung Machine, Cardiopulmonary Bypass
  1 report

Recent Terumo Advanced Perfusion System 1 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936786 ↗
• MalfunctionSep 23, 2026Display or Visual Feedback Problem

  The Field Service Representative (FSR) reported that during preventative maintenance (PM) of the device the centrifugal control unit (CCU) display had missing pixels which caused it to be difficult to read. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870056 ↗
• MalfunctionSep 23, 2026Output Problem

  It was reported that during set-up of the device for a cardiopulmonary bypass (CPB) procedure, the roller pump displayed a 'Stopped: Motor error and service pump' message. As a result, an alternate device was employed. The surgical procedure was completed successfully. There was no delay, no blood loss, nor adverse consequences to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869924 ↗
• MalfunctionSep 22, 2026Inadequate User Interface

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50861414 ↗
• MalfunctionSep 22, 2026Display or Visual Feedback Problem

  It was reported that during set-up of the device for a cardiopulmonary bypass (CPB) procedure, the Central Control Monitor (CCM) display went blank. As a result, an alternate device was employed. The surgical procedure was completed successfully. There was no delay, no blood loss, nor adverse consequences to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50849683 ↗
• MalfunctionSep 21, 2026Inadequate User Interface

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840542 ↗
• MalfunctionSep 18, 2026Device Alarm System

  The Field Service Representative (FSR) reported that during preventive maintenance (PM) of the device, the ultrasonic air sensor (UAS) was not working. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819109 ↗
• MalfunctionSep 17, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808578 ↗
• MalfunctionSep 15, 2026Inadequate User Interface

  The Field Service Representative (FSR) reported that during preventative maintenance (PM) of the device, the Central Control Monitor (CCM) mouse on the touchscreen was off about half of an inch. Recalibration worked for a while, then it drifted again an inch off but was able to be recalibrated again and drifted again. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50773105 ↗
• MalfunctionSep 14, 2026Charging Problem

  Patient problems: Insufficient Information

  MAUDE report 50765732 ↗
• MalfunctionSep 14, 2026Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50765161 ↗
• MalfunctionSep 4, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50614448 ↗
• MalfunctionAug 28, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50508241 ↗
• MalfunctionAug 28, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50499058 ↗
• MalfunctionAug 14, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50253407 ↗

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