Console, Heart-Lung Machine, Cardiopulmonary Bypass

FDA product code DTQ · Class 2 · 102 devices · 2,882 reports · 30 deaths reported · 15 devices named in recalls

• Terumo® Advanced Perfusion System 1 801188

  Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  3 recalls447 reports
• MAQUET CARDIOHELP CARDIOHELP-i

  Maquet Cardiopulmonary AG · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  5 recalls2 deaths64 reports
• MAQUET CARDIOHELP CARDIOHELP System

  Maquet Cardiopulmonary AG · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  4 recalls18 deaths107 reports
• Terumo® Advanced Perfusion System 1 816300

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

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

  Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  230 reports
• ESSENZ HLM

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  1 recall1 death110 reports
• Terumo® Advanced Perfusion System 1 5773

  Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  1 recall78 reports
• S5 Roller Pump 150 RP 150

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  1 death120 reports
• Terumo® Advanced Perfusion System 1 801040

  Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  2 recalls0 reports
• MAQUET CARDIOHELP BS 3/8x3/32 L1.7

  Maquet Cardiopulmonary AG · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  2 recalls0 reports
• Terumo® Advanced Perfusion System 1 816570

  Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  87 reports
• Quantum QRP8

  Spectrum Medical Limited · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  1 recall24 reports
• Terumo® Advanced Perfusion System 1 816572

  Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  73 reports
• CentriMag™ CMAEK00

  Thoratec Corporation · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  1 recall1 death21 reports
• Terumo® Advanced Perfusion System 1 195240

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

  Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  68 reports
• Quantum QRP6

  Spectrum Medical Limited · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  66 reports
• S5 Console 4-position

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  1 death65 reports
• Terumo® Advanced Perfusion System 1 6382

  Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  60 reports
• S5 Double Roller Pump 85 DRP 85

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  54 reports
• Terumo® Advanced Perfusion System 1 5785

  Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  1 recall2 reports
• Electrical Remote-Controlled Tubing Clamp 620 mm

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  52 reports
• Terumo® Advanced Perfusion System 1 5791

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

  Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  1 recall0 reports
• NA Wall holder HKH 8820

  Maquet Cardiopulmonary AG · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  1 recall0 reports
• MAQUET CARDIOHELP CARDIOHELP Emergency Drive (w/o holder)

  Maquet Cardiopulmonary AG · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  1 recall0 reports
• Terumo® Advanced Perfusion System 1 195274

  Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  44 reports
• S5 Console 3-position

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  37 reports
• Terumo® Advanced Perfusion System 1 164267

  Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  31 reports
• Electrical Remote-Controlled Tubing Clamp 500 mm

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  31 reports
• Terumo® Advanced Perfusion System 1 802111

  Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  30 reports
• Quantum QRP4

  Spectrum Medical Limited · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  29 reports
• Bubble Detector Sensor 3/8"

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  1 death26 reports
• S5 Mast Roller Pump MRP 150

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  23 reports
• Terumo® Advanced Perfusion System 1 801764

  Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  22 reports
• ESSENZ Venous clamp

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  22 reports
• SCPC w Level/Bubble & Pressure

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  1 death21 reports
• ESSENZ Cockpit

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  18 reports
• S5 Console 5-position

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  2 deaths16 reports
• S5 Console 4-position

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  15 reports
• S5 Roller Pump 150 RP 150

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  15 reports
• Terumo® Advanced Perfusion System 1 890500

  Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  14 reports
• S5 Mast Roller Pump MRP 85

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  12 reports
• S5 Mast Roller Pump Control Panel for 1 MRP

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  11 reports
• ESSENZ RP85

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  11 reports
• Performer™ R5100052

  Medtronic, Inc. · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  10 reports
• ESSENZ Arterial Clamp- AC arm long (620 mm)

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  10 reports
• SCPC w Temperature & Pressure

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  7 reports
• Quantum QFS4-ST-200

  Spectrum Medical Limited · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  7 reports
• Quantum QSOR

  Spectrum Medical Limited · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  7 reports
• Quantum QSOL

  Spectrum Medical Limited · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  7 reports
• Terumo® Advanced Perfusion System 1 802110

  Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  6 reports
• ESSENZ Arterial Clamp - AC arm short (500mm)

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  6 reports
• Quantum QFS4-ST-075

  Spectrum Medical Limited · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  6 reports
• Bubble Detector Sensor 1/4"

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  5 reports
• Display & Control Module (S5)

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  5 reports
• SCP Pump Control Panel for S5/C5

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  5 reports
• S5 Double Roller Pump 85 DRP 85

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  5 reports
• S5 Console CP5 Console

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  5 reports
• Accessories Bubble Sensor 3/16“ x 1/16”

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  4 reports
• Accessories Bubble Sensor 3/8“ x 3/32“

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  4 reports
• ESSENZ RP150

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  4 reports
• ESSENZ CPD

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  4 reports
• Quantum QFS3-ST-200

  Spectrum Medical Limited · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  4 reports
• Performer™ RR5100052

  Medtronic, Inc. · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  3 reports
• Terumo® Advanced Perfusion System 1 164268

  Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  3 reports
• Bubble Detector Sensor 3/16"

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  3 reports
• Bubble Detector Sensor Module

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  3 reports
• E/P Pack S5

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  3 reports
• E/P Pack UPS Module

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  3 reports
• Quantum QFS2-ST-200

  Spectrum Medical Limited · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  1 death3 reports
• Quantum QSOR

  Spectrum Medical Limited · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  3 reports
• Quantum QFS5-ST-075

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

  Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  2 reports
• C5 System

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  2 reports
• Electrical Remote-Controlled Tubing Clamp 500 mm (S3)

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  2 reports
• Accessories Bubble Sensor 1/4“ x 1/16“

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  2 reports
• S5 Console 5-position

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  2 reports
• MAQUET CARDIOHELP CARDIOHELP Base Unit

  Maquet Cardiopulmonary AG · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  2 reports
• Quantum QSOL

  Spectrum Medical Limited · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  2 reports
• Quantum QFS4-ST-120

  Spectrum Medical Limited · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  2 reports
• Quantum QSOL

  Spectrum Medical Limited · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  2 reports
• Quantum QSOR

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

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

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

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

  Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  1 report
• Variolock Tubing Clamp RP150

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  1 report
• Level Control Sensor

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  1 report
• Level Control Sensor Module

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  1 report
• Cardioplegia Control Sensor Module

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  1 report
• Display & Control Panel 4 pos. (S5)

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  1 report
• S5 Mast Roller Pump Control Panel for 2 MRP85

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  1 report
• Accessories Flow Sensor 3/8“ x 3/32“

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  1 report
• S5 Console 3-position

  LivaNova Deutschland GmbH · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  1 report
• Quantum ® QPF2

  Spectrum Medical Limited · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  1 report
• Quantum QPS

  Spectrum Medical Limited · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  1 report
• Quantum QFS1-ST-200

  Spectrum Medical Limited · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  1 report
• Quantum QFS5-ST-200

  Spectrum Medical Limited · Console, Heart-Lung Machine, Cardiopulmonary Bypass
  1 report