SCPRecalls & reported problems across all models
LivaNova Deutschland GmbH · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 3 models of SCP by LivaNova Deutschland GmbH in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Nov 3, 2016 and Sep 24, 2024 — classified as 2 injuries, 24 malfunctions.
The most frequently reported specific device problem is “Pumping Problem” (5 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
Reports received per month, all models
Most reported SCP problems
Device problems
- Pumping Problem5
- Device Operational Issue4
- Communication or Transmission Problem3
- Mechanical Jam3
- Adverse Event Without Identified Device or Use Problem2
- Appropriate Device Problem Term/Code Not Available2
- Partial Blockage2
- Pumping Stopped2
Patient problems
- No Patient Involvement12
- No Consequences Or Impact To Patient7
- No Clinical Signs, Symptoms or Conditions5
- Loss of consciousness2
SCP models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SCP Pump Control PanelControl, pump speed, cardiopulmonary bypass16 reports
- SCP Drive UnitControl, pump speed, cardiopulmonary bypass5 reports
- SCP Pump Control Panel for S5/C5CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS5 reports
Recent SCP adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionApr 2, 2024Pumping Problem; Pumping Problem
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE KNOB OF A SCPC PUMP WAS NOT WORKING DURING A PROCEDURE THERE IS NO REPORT OF ANY PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19019113 ↗MalfunctionDec 22, 2023Pumping Problem; Pumping Problem
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, DURING A PROCEDURE, THE SCP PUMP KEEPS RESETTING THE RPM TO 1000 AND DISPLAYS ERROR EPROM DEFECTIVE (E04). THERE IS NO REPORT OF ANY PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18387629 ↗MalfunctionApr 19, 2023Pumping Stopped; Pumping Stopped
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THERE WAS A FLOW DROPPING ON CENTRIFUGAL PUMP SYSTEM WHEN ROTATION PER MINUTE (RPM) WAS AT ITS MAXIMUM. THE ISSUE OCCURRED DURING PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16767219 ↗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 ↗MalfunctionOct 3, 2019Unexpected Shutdown; Unexpected Shutdown
LIVANOVA (B)(4) RECEIVED A REPORT THAT A CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP SHUT OFF AFTER ABOUT 10 MIN DURING PROCEDURE. THE ISSUE OCCURRED TWICE. THE DEVICE WAS SWITCHED OUT. THERE WAS NO REPORT OF PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9150310 ↗MalfunctionAug 8, 2019Partial Blockage; Partial Blockage
MalfunctionAug 8, 2019Partial Blockage; Partial Blockage
MalfunctionJun 28, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
LIVANOVA (B)(4) RECEIVED A REPORT THAT A CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP DISPLAYED AN ERROR MESSAGE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8743008 ↗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
MalfunctionMar 22, 2019Communication or Transmission Problem; Communication or Transmission Problem
MalfunctionMar 21, 2019Mechanical Jam; Mechanical Jam
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
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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