SCPC w Level/Bubble & PressureRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 04033817901020), received between Jan 5, 2017 and Sep 25, 2026 — classified as 1 death, 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (6 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionSep 29, 2022Pumping Stopped; Pumping Stopped

  LIVANOVA RECEIVED REPORT THAT A SCP DRIVE UNIT COULD BE CONTROLLED BY THE SCP CONTROL PANEL FOR ABOUT 20 SECONDS AND THEN THE DRIVE UNIT WOULD ROTATE TO MAXIMUM RPM, THEN DROP TO 0 RPM. IN ADDITION AN ERROR CODE ASSOCIATED WITH A DIFFERENCE BETWEEN THE SET VALUE AND THE ACTUAL VALUE MORE THAN 1000 RPM WAS DISPLAYED. THE ISSUE WAS IDENTIFIED DURING MAINTENANCE AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15508886 ↗
• MalfunctionSep 1, 2022Pumping Stopped; Pumping Stopped

  LIVANOVA RECEIVED REPORT OF A MECHANICAL FAILURE OF A CENTRIFUGAL PUMP CONSOLE NOT GENERATING FORWARD FLOW DURING ECMO SUPPORT. THERE WAS NO PATIENT INJURY. ON AUGUST 23, 2022 LIVANOVA RECEIVED A MEDWATCH NOTIFICATION (B)(4). WITHIN THE REPORT IT WAS STATED THE FOLLOWING: PATIENT ON VA ECMO FOR PULMONARY HYPERTENSION (PHTN) LISTED AND DELISTED FOR HEART/LUNG TRANSPLANT DURING HER COURSE OF ECMO RUN. ECMO CANNULAS PLACED IN RIGHT INTERNAL JUGULAR (RIJ) AND RIGHT COMMON CAROTID ARTERY (RCCA). SHE IS ACTIVE AND VERBAL. SHE REFUSES NECK COLLAR WHILE IN BED. SHE SEEMS AGITATED IN THE LAST COUPLE OF DAYS AND HASN'T BEEN ABLE TO SLEEP. SHE HAD TWO PRIOR CIRCUIT EVENTS WHICH SHE REQUIRED A PART OF HER CIRCUIT REPLACED ONCE AND A WHOLE CIRCUIT CHANGE FOR THE SECOND EVENT BOTH RELATED TO AIR BUBBLE ALARM THAT HAS INTERRUPTED FORWARD FLOW. ON BOTH EVENTS, NO CIRCUIT AIR WERE NOTED BY ECMO SPECIALISTS. BEDSIDE RN HAD NOTED DAMPENING OF BLOOD PRESSURE TRACING AND WHILE ADJUSTING ARTERIAL LINE POSITION ON HER WRIST, SHE FOUND PATIENT UNRESPONSIVE. ECMO SPECIALISTS, AT THE SAME TIME DURING HER HOURLY CIRCUIT ASSESSMENT AND CANNULA CHECK NOTICED PATIENT UNRESPONSIVE AS WELL. THIS HAD OCCURRED AFTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15335763 ↗
• MalfunctionJul 7, 2022Unexpected Shutdown; Unexpected Shutdown

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A CENTRIFUGAL PUMP CONSOLE DID NOT DISPLAY BATTERY INFORMATION AND SHUT DOWN WHEN UNPLUGGED. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14942276 ↗
• MalfunctionJan 5, 2022Pumping Problem; Pumping Problem

  LIVANOVA RECEIVED REPORT ABOUT A CONTROL KNOB NOT WORKING SOMETIMES. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13168178 ↗
• MalfunctionDec 13, 2021Decreased Pump Speed; Decreased Pump Speed

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12983546 ↗
• MalfunctionJun 25, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  LIVANOVA (B)(4) RECEIVED A REPORT THAT A CENTRIFUGAL PUMP CONSOLE STOPPED MEASURING THE PRESSURE AND AN ERROR MESSAGE WAS DISPLAYED DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8729955 ↗
• MalfunctionJun 7, 2019No Display/Image; No Display/Image

  SEE INITIAL REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8678256 ↗
• InjuryMay 28, 2019Unexpected Shutdown; Unexpected Shutdown

  SEE INITIAL REPORT.

  Patient problems: No Information

  MAUDE report 8645323 ↗
• MalfunctionMar 13, 2018Loss of Power; Loss of Power

  LIVANOVA (B)(4) RECEIVED A REPORT THAT A CENTRIFUGAL PUMP CONSOLE LOST POWER DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7333856 ↗
• MalfunctionDec 20, 2017No Display/Image; No Display/Image

  LIVANOVA (B)(4) RECEIVED A REPORT THAT THE DISPLAY OF THE CENTRIFUGAL PUMP CONSOLE BECAME BLANK AND THE BACKGROUND TURNED BLUE DURING SETUP. THE DEVICE WAS RESTARTED AND BEGAN TO FUNCTION AS EXPECTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7135926 ↗
• MalfunctionMay 5, 2017No Display/Image; No Display/Image

  LIVANOVA (B)(4) RECEIVED A REPORT THAT THE DISPLAY OF THE CENTRIFUGAL PUMP CONSOLE WAS BLANK DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6549754 ↗
• MalfunctionJan 5, 2017Overheating of Device; Overheating of Device

  SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE CHASSIS OF THE SORIN CENTRIFUGAL PUMP CONSOLE OVERHEATED DURING THE BATTERY DISCHARGE TEST DURING MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6227450 ↗