SCPCRecalls & reported problems across all models

We found 2 models of SCPC by LivaNova Deutschland GmbH in the FDA's device registry (GUDID). Together they are named in 28 adverse event reports in the FDA's MAUDE database, received between Jan 5, 2017 and Sep 25, 2026 — classified as 1 death, 1 injury, 26 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (7 reports).

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

Most reported SCPC problems

SCPC models

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

• SCPC w Level/Bubble & Pressure

  CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  1 death21 reports
• SCPC w Temperature & Pressure

  CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  7 reports

Recent SCPC adverse event reports

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

• MalfunctionSep 25, 2026Pumping Stopped

  LivaNova Deutschland received a report that, while a patient was off the ECMO machine and undergoing a CT scan, centrifugal pump main unit¿s control panel suddenly lost power for 15 minutes, causing the centrifugal pump to stop. Normal operation was resumed after connecting the device to AC power. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50893942 ↗
• MalfunctionOct 17, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23325564 ↗
• MalfunctionSep 5, 2025Display or Visual Feedback Problem; Pumping Stopped; Display or Visual Feedback Problem; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A SCPC GAVE BLANK BLUE SCREEN AND A ALARMING TONE DURING PRIMING AND SET UP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22979351 ↗
• MalfunctionMay 20, 2025Low Readings; Low Readings

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A PATIENT SENSOR OF A SCPC DID NOT READING ANYTHING. NO FURTHER INFORMATION IS AVAILABLE. IT CANNOT BE EXCLUDED THAT THE AFFECTED SENSOR IS A BUBBLE ONE AND THAT DID NOT DETECT AIR BUBBLE. THE ISSUE OCCURRED DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22050829 ↗
• MalfunctionMay 16, 2025Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22036607 ↗
• MalfunctionMay 7, 2025Unexpected Shutdown; Unexpected Shutdown

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT RELATED TO A SCPC DOWN DURING PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE AT THE MOMENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976991 ↗
• MalfunctionApr 30, 2025Pumping Problem; Pumping Problem

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21932974 ↗
• MalfunctionMar 24, 2025Unexpected Shutdown; Unexpected Shutdown

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A SCPC (STOCKERT CENTRIFUGAL PUMP SYSTEM) DID TURN OFF WHEN UNPLUGGED FROM THE MAINS. THE BATTERY DID NOT WORK. THE ISSUE OCCURRED POST PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21675232 ↗
• MalfunctionMar 19, 2025Unexpected Shutdown; Unexpected Shutdown

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21642187 ↗
• DeathMay 3, 2024Pumping Stopped; Pumping Stopped

  LIVANOVA HAS RECEIVED A REPORT THAT THE SCPC PUMP STOPPED DURING THE SERVICE, THE SCREEN PRESENTED AS THE INTIAL SCREEN. AFTER RESTARTED, THE PUMP RUN FOR A WHILE AND THE EQUIPMENT STOPPED AGAIN. THE OPERATION WAS COMPLETED WITH CP5 AS A REPLACEMENT. ACCORIND TO INFORMATION, THE EQUIPMENT FAILURE CAUSED ARTERIAL BLOOD REGURGITATION, AND CARDIOPULMONARY RESUSCITATION WAS PERFORMED. PLEASE CREATE A NEW CUSTOMER IN ETQ. THANK YOU! HOSPITAL: (B)(6), ADDRESS: (B)(6).

  Patient problems: Cardiac Arrest; Nervous System Injury

  MAUDE report 19236608 ↗
• MalfunctionApr 23, 2024Unexpected Shutdown; Unexpected Shutdown

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A CENTRIFUGAL PUMP CONSOLE SWITCHED OFF DURING OPERATION EVEN THOUGH THE BATTERY CAPACITY IS 60-70% AMOUNTS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19161793 ↗
• MalfunctionApr 2, 2024Pumping Problem; Pumping Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, DURING A PROCEDURE, THE SCPC INTERMITTENTLY DISPLAYED THE ALARM INCONSISTENT ACTUAL VALUE IMPULSES (E78). MEANWHILE, THE PUMP WAS HOT TO THE TOUCH AND THE FLOW OF BLOOD WAS UNSTABLE. THERE IS NO REPORT OF ANY PATIENT INJURY. THE RELEVANT PERSONAL COULD NOT TROUBLESHOOT THE PROBLEM AND THE TECHNICIAN COULD NOT JUDGE FOR THE CAUSE EITHER: THE SCPC IS CURRENTLY OUT OF SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19019120 ↗
• MalfunctionNov 14, 2023Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: Coma; Ischemia Stroke; Shock

  MAUDE report 18130127 ↗
• MalfunctionAug 8, 2023Device Sensing Problem; Pumping Problem; Device Sensing Problem; Pumping Problem

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17480825 ↗
• MalfunctionApr 13, 2023Pumping Problem; Pumping Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE KNOB OF A CENTRIFUGAL PUMP CONSOLE DID NOT TURN PROPERLY. THE ISSUE OCCURRED DURING MAINTENANCE ACTIVITY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16731503 ↗

Other LivaNova Deutschland GmbH products

• Heater-Cooler System2 models · 311 reports · 1 recall
• ESSENZ8 models · 185 reports · 1 recall
• CP54 models · 96 reports · 1 recall
• S5 Console7 models · 141 reports
• S5 Roller Pump 1502 models · 135 reports
• Electronic Gas Blender3 models · 106 reports
• Electrical Remote-Controlled Tubing Clamp3 models · 85 reports
• S5 Double Roller Pump 852 models · 59 reports