Console, Heart-Lung Machine, Cardiopulmonary Bypass

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2026-02-05Open, ClassifiedUnder Investigation by firm

  Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;

  Internal investigations have identified an issue with the durability of the connecting cable near the connection to the Venous Bubble Sensor. Excessive bending of the connecting cable can lead to full damage of the Venous Bubble Sensor or loose cable contact, which may trigger the errors Ven. bubble sensor defective or Ven. bubble sensor disconnected on the connected medical device. These errors can occur temporarily when the connecting cable is moved or permanently if the connection is fully compromised.

• 2025-05-27Open, ClassifiedUnder Investigation by firm

  Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.

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

• 2024-11-27Open, ClassifiedSoftware change control

  Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software

  Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained through backup control panel, but second reset may occur, may lead to gas blender standby, then gas blender must be reactivated using user interface on blender, sensors deactivated until new case started; GUI reset can lead to Hypoxia and Hypoperfusion.

• 2024-10-24CompletedComponent design/selection

  Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00

  The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.

• 2024-09-30Open, ClassifiedProcess design

  CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). Product REF Numbers: 701072780; 701048012

  CARDIOHELP-i System was not properly tested to measure leakage current

• 2024-05-16Open, ClassifiedUnder Investigation by firm

  CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.

  The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.

• 2024-02-08Open, ClassifiedLabeling mix-ups

  Bubble Sensor (REF: 70105.5720)

  The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the device.

• 2023-12-21Open, ClassifiedComponent design/selection

  Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802

  Firm received complaints of breaks in the insulation, shielding, or wires of the venous probe connection cable. Fracture of the venous probe cable may influence the management of extracorporeal support. Patient may be exposed to inappropriate blood flow, blood temperature, or hematocrit/hemoglobin levels as a result of the CARDIOHELP-i not receiving information from the venous probe.

• 2023-12-14Open, ClassifiedLabeling design

  CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass Part Number: 701072780, (CARDIOHELP-I US); 701048012 (CARDIOHELP-I NON US)

  Certain factory settings for the device were incorrectly described in the IFU-related to the warning limits for PVen and PAux, and the default settings for the venous bubble sensor (VBS) and the automatic lock in the Minimized Extracorporeal Circulation (MECC) ThApp

• 2023-12-07Open, ClassifiedUnder Investigation by firm

  CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.

  Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This issue can lead to the patient being exposed to inappropriate low blood flow. Potential associated harms are ischemia and hypoxia.