SCP Pump Control PanelRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04033817900986), received between Nov 3, 2016 and Sep 24, 2024 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Device Operational Issue” (4 reports).

4 other recalls cover devices cleared under the same FDA submission (K011838); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2024Pumping Problem; Pumping Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A SCP FLOW MEASUREMENT ON THE PANEL IS DEFECTIVE DURING A PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20288913 ↗
• MalfunctionAug 24, 2022Decreased Pump Speed; Increased Pump Speed; Decreased Pump Speed; Increased Pump Speed

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT OF A CENTRIFUGAL PUMP SCP CONTROL PANEL WITH A DEFECTIVE SPEED CONTROL KNOB DURING PROCEDURE. REPORTEDLY THE PUMP SPEED COULD ONLY BE REGULATED UP TO 300 RPMS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15281397 ↗
• InjuryMar 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIVANOVA RECEIVED A MEDWATCH REPORT MW5106649 STATING THAT THE NP HAD HIS HAND ON THE SCP CENTRIFUGAL PUMP AND INADVERTENTLY FLIPPED THE POWER SWITCH TO OFF. THE PUMP WAS IMMEDIATELY TURNED BACK ON BUT THE PATIENT BEGAN IMMEDIATELY TO LOSE CONSCIOUSNESS. REPORTEDLY THE PUMP WAS THEN MOVED TO HAND CRANK TO RESTORE FLOWS SINCE THE PATIENT HAD SLOUCHED DOWN AND HIS RETURN CANNULA WAS KINKED OFF WHICH DELAYED THE FLOWS. ONCE THE KINK WAS FIXED, THE FLOWS WERE RESTORED AND THE PATIENT REGAINED CONSCIOUSNESS. THE PATIENT DID NOT REQUIRE CPR AND HAD NO RECOLLECTION OF THE EVENT. IT WAS REPORTED THAT THE SWITCH OF THE SCP CENTRIFUGAL PUMP WAS TAPED TO THE ON POSITION WITH A TONGUE DEPRESSOR.

  Patient problems: Loss of consciousness

  MAUDE report 13657921 ↗
• InjuryMar 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIVANOVA RECEIVED A MEDWATCH REPORT MW5106649 STATING THAT THE NP HAD HIS HAND ON THE SCP CENTRIFUGAL PUMP AND INADVERTENTLY FLIPPED THE POWER SWITCH TO OFF. THE PUMP WAS IMMEDIATELY TURNED BACK ON BUT THE PATIENT BEGAN IMMEDIATELY TO LOSE CONSCIOUSNESS. REPORTEDLY THE PUMP WAS THEN MOVED TO HAND CRANK TO RESTORE FLOWS SINCE THE PATIENT HAD SLOUCHED DOWN AND HIS RETURN CANNULA WAS KINKED OFF WHICH DELAYED THE FLOWS. ONCE THE KINK WAS FIXED, THE FLOWS WERE RESTORED AND THE PATIENT REGAINED CONSCIOUSNESS. THE PATIENT DID NOT REQUIRE CPR AND HAD NO RECOLLECTION OF THE EVENT. IT WAS REPORTED THAT THE SWITCH OF THE SCP CENTRIFUGAL PUMP WAS TAPED TO THE ON POSITION WITH A TONGUE DEPRESSOR.

  Patient problems: Loss of consciousness

  MAUDE report 13657920 ↗
• MalfunctionAug 8, 2019Partial Blockage; Partial Blockage

  SEE INITIAL REPORT.

  Patient problems: No Patient Involvement

  MAUDE report 8873333 ↗
• MalfunctionAug 8, 2019Partial Blockage; Partial Blockage

  SEE INITIAL REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8872666 ↗
• MalfunctionApr 30, 2019Mechanical Jam; Mechanical Jam

  LIVANOVA (B)(4) RECEIVED A REPORT THAT A CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP ENCODER BECAME STUCK AND DIFFICULT TO ROTATE DURING INSTALLATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8564383 ↗
• MalfunctionMar 22, 2019Pumping Problem; Pumping Problem

  SEE INITIAL REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8443386 ↗
• MalfunctionMar 22, 2019Communication or Transmission Problem; Communication or Transmission Problem

  SEE INITIAL REPORT.

  Patient problems: No Patient Involvement

  MAUDE report 8443140 ↗
• MalfunctionMar 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  LIVANOVA (B)(4) RECEIVED A REPORT THAT THE ENCODER FROM A CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP BECAME LOOSE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8411627 ↗
• MalfunctionFeb 20, 2019Communication or Transmission Problem; Communication or Transmission Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE CONTROL KNOB OF A CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP WAS GRINDING WHILE TURNING. THE ISSUE WAS IDENTIFIED DURING TRAINING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8353705 ↗
• MalfunctionFeb 20, 2019Communication or Transmission Problem; Communication or Transmission Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE CONTROL KNOB OF A CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP WAS GRINDING WHILE TURNING. THE EVENT OCCURRED DURING TRAINING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8353690 ↗
• MalfunctionMay 26, 2017Device Operational Issue; Device Operational Issue

  LIVANOVA (B)(4) RECEIVED A REPORT THAT THE FLOW RATE WAS NOT DISPLAYED ON THE CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6595971 ↗
• MalfunctionMar 14, 2017Device Operational Issue; Physical Property Issue; Device Operational Issue; Physical Property Issue

  (B)(4) RECEIVED A REPORT THAT THE ENCODER OF THE CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP WOULD NOT CONTROL THE FLOW SPEED DURING PRIMING. THE USER STATED THAT THE KNOB WAS FOUND TO BE LOOSE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6404820 ↗
• MalfunctionJan 11, 2017Device Operational Issue; Device Operational Issue

  SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE SPEED ADJUSTMENT ENCODER OF THE SORIN CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP DID NOT FUNCTION PROPERLY POST-PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Patient Involvement

  MAUDE report 6244562 ↗
• MalfunctionNov 3, 2016Device Operational Issue; Device Operational Issue

  SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE FLOW SENSOR OF THE SORIN CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP FAILED INTERMITTENTLY DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6075716 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K011838. One submission often covers many models, so check the product and lot details in each record.

• Z-2439-2020 · Aug 26, 2019 · Terminated
  Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI: 04033817900993
• Z-2440-2020 · Aug 26, 2019 · Terminated
  Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI: 04033817900986
• Z-0167-2013 · Sep 20, 2012 · Terminated
  SCP Pump Control Panel, Product Code: 60-02-50, Serial Numbers: 60S09131, 60S09133-60S09135, 60S09140-60S09142, 60S08954. The SCP is a cardiopulmonary bypass speed control device
• Z-0166-2013 · Sep 20, 2012 · Terminated
  SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139. The SCP is a cardiopulmonary bypass speed control device indicated