CP5 Pump Control Panel (UDI 04033817901006)Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 04033817901006), received between Nov 30, 2016 and Oct 17, 2025 — classified as 1 injury, 52 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (18 reports).

1 FDA recall record name this device's identifier.

3 other recalls cover devices cleared under the same FDA submission (K112225); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 30, 2017Terminated

   Possibility that the automatic line closure by the Electronic Remote-Controlled (ERC) clamp after detection of an air bubble could take longer than is intended by design in the CP5 system.

   Z-0401-2018 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2025Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23325841 ↗
• MalfunctionAug 7, 2025Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, POST-PROCEDURE, THE CP5 GAVE SHORT INTERNAL ERROR MESSAGE (NO CODE). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22735676 ↗
• MalfunctionFeb 25, 2025Structural Problem; Structural Problem

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21458348 ↗
• MalfunctionOct 23, 2024Unexpected Shutdown; Unexpected Shutdown

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE SCREEN OF A CP5 SHUT OFF DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20512542 ↗
• MalfunctionJun 14, 2024Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND HAS RECEIVED A REPORT THAT, DURING A PROCEDURE, CP5 PUMP CONTROL PANEL LOST SET PARAMETERS CAUSING RPMS TO FALL TO ZERO, SET COAST SPEED OF 1300RPMS WAS NOT ACHIEVED RESULTING IN RETROGRADE. SEVERAL ERRORS POPULATED DURING THE EVENT. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19542355 ↗
• MalfunctionMar 7, 2024Unintended Movement; Unintended Movement

  SEE INTIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18854433 ↗
• MalfunctionDec 29, 2023Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18417466 ↗
• MalfunctionJul 18, 2023Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17343045 ↗
• InjuryApr 3, 2023Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16663419 ↗
• MalfunctionMar 28, 2023Pumping Stopped; Pumping Stopped

  SEE INTIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16628036 ↗
• MalfunctionMar 3, 2023Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A CENTRIFUGAL PUMP 5 (CP5) DISPLAYED AN ERROR MESSAGE (UNKNOWN) DURING PROCEDURE. THE UNIT WAS TURNED OFF AND ON AND THE SCREEN WAS BLACK. THEN, IT WAS TURNED OFF AND ON AGAIN AND IT WORKED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16476737 ↗
• MalfunctionOct 27, 2022No Flow; No Flow

  LIVANOVA RECEIVED REPORT OF GETTING BACK FLOW (NEGATIVE FLOW) FROM PATIENT PRIOR TO STARTING THE PROCEDURE DURING TESTING OF THE CIRCUIT, EVEN IF CENTRIFUGAL PUMP 5 (CP5) WAS SET TO 1500 RPMS. CP5 ALARMED IMMEDIATELY AT THE NEGATIVE FLOW LEVEL AND CLAMPED THE LINE. PERFUSIONIST OBSERVED THAT THE REVOLUTION HEAD WAS SPINNING, BUT COULD NOT IDENTIFY WHY NO POSITIVE FLOW COULD BE ACHIEVED. ULTIMATELY DECIDED TO SWITCH TO A BACKUP PUMP WITH A NEW PATIENT CIRCUIT. PROCEDURE WAS ACCOMPLISHED WITHOUT PATIENT IMPACT. SECOND PERFUSIONIST TESTED THE MACHINE AND PATIENT CIRCUIT THAT HAD ISSUE AFTER THE PROCEDURE AND COULD NOT REPRODUCE THE REPORTED ISSUE AND WANTED THE MACHINE TO BE CHECKED BY A SERVICE TECHNICIAN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15679560 ↗
• MalfunctionAug 5, 2022Pumping Stopped; Pumping Stopped

  LIVANOVA RECEIVED REPORT THAT A CENTRIFUGAL PUMP CP5 TURNED OFF BY ITSELF DURING PROCEDURE, THE SCREEN BECAME BLACK AND THE DRIVE UNIT STOPPED). THE USER WAITED 3 SECONDS BUT THE CP5 DID NOT WORK, SO THE DEVICE WAS TURNED OFF AND BACK ON. THE CP5 AND DRIVE UNIT CONTINUED WORKING FINE DURING THE REST OF THE SURGERY AND IT WAS USED ALSO THE NEXT DAY WITHOUT PROBLEMS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15174222 ↗
• MalfunctionJul 8, 2022Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A CENTRIFUGAL PUMP 5 (CP5) GAVE A MOTOR CONTROL FAILURE ERROR MESSAGE DURING INSTALLATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14955309 ↗
• MalfunctionJun 29, 2022Unexpected Shutdown; Unexpected Shutdown

  LIVANOVA RECEIVED REPORT THAT A CP5 CENTRIFUGAL PUMP SUDDENLY TURNED OFF ON ITS OWN DURING CPB WHILE SUPPORTING PATIENT PRIOR TO THE AORTIC CROSS CLAMP BEING APPLIED. WITH THE CONSOLE OFF NO FORWARD FLOW WAS BEING DELIVERED BY THE CPB PUMP TO THE PATIENT. REPORTEDLY, CPB HAD ONLY BEEN COMMENCED FOR UNDER 10 MINUTES AND THE PATIENT STILL HAD A CLOSED HEART WITH A PERFUSABLE RHYTHM WHEN THE INCIDENT OCCURRED. CLAMPING OUT THE ARTERIAL AND VENOUS LINES WERE PERFORMED TO PREVENT FURTHER BLOOD VOLUME FROM THE PATIENT TO BE DRAINED INTO THE CPB RESERVOIR. LINES WERE RE-CLAMPED OUT AND PUMP CONSOLE TROUBLESHOOTED BUT IT WAS NOT POSSIBLE TO IDENTIFY ISSUE AS TO WHY THE DRIVE CONSOLE TURNED OFF. THE CENTRIFUGAL PUMP WAS HAND-CRANKED WHILE THE DRIVE UNIT AND THE CONTROL PANEL WERE REPLACED. THE PATIENT WAS STABLE AND NO SERIOUS INJURY OCCURRED AND CPB RESTARTED WITH NEW CP5 SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14853426 ↗
• MalfunctionJun 22, 2022Pumping Stopped; Pumping Stopped

  LIVANOVA RECEIVED REPORT THAT ON BOOT UP OF A CENTRIFUGAL PUMP 5 (CP5) AN ERROR MESSAGE ASSOCIATED TO INTERNAL MALFUNCTION WAS DISPLAYED. THE DEVICE WAS REPLACED BEFORE STARTING THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14776144 ↗
• MalfunctionJun 1, 2022Unexpected Shutdown; Unexpected Shutdown

  LIVANOVA RECEIVED REPORT OF A CENTRIFUGAL PUMP CP5 SHUT DOWN DURING PROCEDURE. REPORTEDLY, THE SCREEN WENT BLACK AND THERE WAS NO FLOW. IT WAS REPORTED THAT THE CUSTOMER DID NOT RECALL IF THE BACK OF THE CP5 CONSOLE WAS INADVERTENTLY TOUCHED. HOWEVER, IT WAS DECIDED TO SHUT DOWN ALL THE CONSOLE AND RESTART IT. WITHIN SECONDS, THE POWER CAME BACK TO THE CENTRIFUGAL PUMP CONSOLE AND WE WERE ABLE TO RESUME BYPASS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14562943 ↗
• MalfunctionMay 20, 2022Failure to Read Input Signal; Failure to Read Input Signal

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14453217 ↗
• MalfunctionApr 8, 2022Pumping Stopped; Pumping Stopped

  LIVANOVA RECEIVED REPORT THAT RPMS AND FLOW ON WOULD GO TO ZERO ON A CENTRIFUGAL PUMP 5 (CP5) DURING PROCEDURE. REPORTEDLY, THREE ALARMS WERE DISPLAYED. THE FIRST ONE WAS ASSOCIATED TO GRAPHIC DISPLAY FAILURE, THE SECOND TO A SHORT-TERM INTERNAL MALFUNCTION AND THE THIRD TO NO MONITORING/CONTROL FUNCTION ACTIVE FOR THE PUMP. THUS, THE SYSTEM WAS SWITCHED OUT WITH ANOTHER. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14049956 ↗
• MalfunctionFeb 22, 2022Pumping Stopped; Pumping Stopped

  LIVANOVA (B)(4) RECEIVED A REPORT THAT A CENTRIFUGAL PUMP 5 (CP5) SHUT OFF DURING PROCEDURE. THE CUSTOMER PERFORMED HAND-CRANK UNTIL THE CP5 TURNED BACK ON.THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13577818 ↗
• MalfunctionFeb 15, 2022Pumping Stopped; Pumping Stopped

  LIVANOVA (B)(4) RECEIVED A REPORT THAT DURING EXTRACORPOREAL CIRCULATION, THE CP5 CONTROL PANEL BLACKED OUT SHORTLY AFTER THE A TIMEOUT ALARM BETWEEN THE CP5 AND THE ARTERIAL CLAMP. REPORTEDLY THE PUMP STOPPED DURING TIMEOUT ERROR. THE CONTROL PANEL WAS TURNED OFF AND BACK ON AND THE ISSUE IMPROVED. THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13531671 ↗
• MalfunctionFeb 8, 2022Decreased Pump Speed; Decreased Pump Speed

  LIVANOVA (B)(4) RECEIVED A REPORT THAT DURING BYPASS, A LEVEL ALARM CORRECTLY STOPPED THE CENTRIFUGAL PUMP 5 (CP5) AND FOLLOWING TO THAT THE CP5 SCREEN FROZE AND THE ARTERIAL CLAMP REMAINED CLOSED. REPORTEDLY, IT WAS NOT POSSIBLE TO PRESS ANYTHING ON THE SCREEN AND IT SEEMED THERE WAS ALSO NO RESPONSE FROM THE SPEED CONTROL KNOB. THE PUMP WAS TURNED OFF AND BACK ON AND BYPASS COULD BE RESUMED. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13477693 ↗
• MalfunctionJan 27, 2022Mechanical Jam; Mechanical Jam

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13366060 ↗
• MalfunctionDec 27, 2021Unexpected Shutdown; Unexpected Shutdown

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13088903 ↗
• MalfunctionDec 22, 2021Pumping Stopped; Pumping Stopped

  LIVANOVA (B)(4) RECEIVED A REPORT THAT THE MESSAGE ¿NO MONITORING ON PUMP 2B¿ (CARDIOPLEGIA PUMP) REFERRING TO THE STOP LINK FUNCTION APPEARED ON A CENTRIFUGAL PUMP 5 (CP5) ¿DURING PRIMING WHEN THE PERFUSIONIST WAS AWAY FROM THE PUMP. REPORTEDLY, THE PRESSURE READING WAS NEGATIVE WITH ASSOCIATED ALARM AND THE CENTRIFUGAL PUMP STOPPED. THE CP5 SCREEN WAS STILL SAYING THE SAME AND WHEN IT WAS ATTEMPTED TO PRESS THE CLAMP FUNCTION BUTTON TO CLOSE THE CLAMP IT APPEARED TO BE FROZEN. THE PUMP WAS POWER CYCLED AND IT WORKED NORMALLY AGAIN. HOWEVER, SINCE CPB HAD NOT YET BEEN INITIATED, THE USER REPLACED THE CP5 WITH ANOTHER UNDER LIVANOVA TECHNICAL SERVICE ADVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13060866 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112225. One submission often covers many models, so check the product and lot details in each record.

• Z-0787-2022 · Dec 17, 2021 · Terminated
  Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypass speed control dev
• Z-0857-2014 · Dec 4, 2013 · Terminated
  CP5 centrifugal pump system Product Usage: The Stockert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
• Z-1329-2012 · Feb 23, 2012 · Terminated
  Pump control panel. The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours.