CP5 Drive UnitRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 04033817900948), received between Dec 2, 2016 and Apr 17, 2026 — classified as 2 injuries, 30 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Pumping Stopped

  LIVANOVA RECEIVED A REPORT ABOUT A CP5 SYSTEM DISPLAYING THE ERROR MESSAGE "MOTOR CONTROL FAILURE". THE EVENT OCCURRED DURING PRIMING. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911192 ↗
• MalfunctionMar 11, 2026Pumping Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE CENTRIFUGAL PUMP CP5, USED AS ARTERIAL PUMP, PROVIDED UNSTABLE FLOW DURING PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24573777 ↗
• MalfunctionJun 12, 2025Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, JUST BEFORE THE PROCEDURE STARTED, THE CP5 PUMP WAS STOPPED. THIS WAS USED AS A SUCTION. THE PERFUSIONIST WAS THEN ABLE TO QUICKLY SWITCH TO ANOTHER PUMP THAT WAS FREE. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22195034 ↗
• MalfunctionMay 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT OF AN ISSUE WITH CP5 DRIVER UNIT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22084826 ↗
• MalfunctionNov 8, 2024Pumping Problem; Pumping Problem

  LIVANOVA RECEIVED A REPORT THAT A YELLOW ICON SHOWED UP WHEN CUSTOMER TRIED TO FORWARD THE FLOW, THE CP5 HAD DROPPED THE FLOW TO 0 AND THERE WAS NO FORWARD FLOW. PERFUSIONIST CANNOT RECALL THE INFORMATION ASSOCIATED TO THE DISPLAYED ALARM (YELLOW TRIANGLE ALARM ON CP5 PANEL). THROUGH FOLLOW UP, THE PERFUSIONIST INFORMED LIVANOVA THE PUMP WOULD NOT HAVE FORWARD FLOW FOR ABOUT 5-7 MINUTES. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20637895 ↗
• MalfunctionOct 31, 2024Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20578109 ↗
• MalfunctionOct 30, 2024Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A CP5 GAVE AN ERROR MESSAGE AND PUMP DID NOT RUN. THE ISSUE OCCURRED AT SETUP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20565932 ↗
• MalfunctionOct 10, 2024Pumping Problem; Pumping Problem

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20415955 ↗
• MalfunctionAug 5, 2024Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19906206 ↗
• MalfunctionJun 14, 2024Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19542361 ↗
• MalfunctionJun 14, 2024Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT DURING PRIMING A CENTRIFUGAL PUMP 5 (CP5) TURNED OFF AND THEN BACK ON BY ITSELF, AT LEAST TWO TIMES, AND AN ERROR MESSAGE ON S5 CONSOLE CONTROL PANEL APPEARED INDICATING A TEMPORARY INTERNAL FAILURE OF THE CENTRIFUGAL PUMP. THE CUSTOMER SUBSEQUENTLY TURNED THE ENTIRE S5 CONSOLE OFF AND ON AGAIN WITHOUT CREATING ANY OTHER PROBLEMS DURING THE SURGERY. IT WAS CLAIMED BY THE CUSTOMER THAT ALSO PRESSURE MODULE WAS DEFECTIVE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19541733 ↗
• MalfunctionMay 22, 2024Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A CP5 DRIVE UNIT STOPPED RUNNING; THERE WAS NO FLOW AND RPM¿S WERE SHOWING ON THE CP5 DISPLAY. THEN IT STARTED RUNNING AGAIN BY ITSELF. THE ISSUE OCCURRED PRIOR TO GOING ON BYPASS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19372014 ↗
• MalfunctionMar 29, 2024Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A CENTRIFUGAL PUMP 5 (CP5) STOPPED INVOLUNTARY DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19002290 ↗
• MalfunctionMar 21, 2024Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18950066 ↗
• MalfunctionJan 3, 2024Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP GAVE MOTOR CONTROL FAILURE ERROR MESSAGE.THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18434375 ↗
• InjuryNov 8, 2023Pumping Stopped; Pumping Stopped

  LIVANOVA DEUTSCHLAND HAS RECEIVED A REPORT THAT, DURING A CARDIOPULMONARY BYPASS, THE PUMP STOPPED WORKING. THERE WAS NO CIRCULATION UNTIL A NEW BYPASS MACHINE WAS HOOKED UP AND STARTED. ACCORIND TO INFORMATION THIS TOOK APPROXIMATELY 8-10 MINUTES AND REQUIRED MEDICATIONS, BLOOD PRODUCTS AND CARDIAC MASSAGE. STAFF FROM PERFUSION IDENTIFIED THE TUBING AS A POSSIBLE CAUSE OF MALFUNCTION. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18092429 ↗
• InjuryNov 8, 2023Pumping Stopped; Pumping Problem; Pumping Stopped; Pumping Problem

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18092413 ↗
• MalfunctionOct 12, 2023Infusion or Flow Problem; Infusion or Flow Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT AN UNKNOWN EVENT, OCCURRED AT 10:57, TRIGGERED A NEGATIVE PRESSURE ALARM ON A CENTRIFUGAL PUMP 5 (CP5); THE MAXIMUM AMOUNT OF FLOW ACHIEVED WAS 1.74 LPM WITH MAXED OUT RPMS OF 3500. THE ISSUE OCCURRED DURING PROCEDURE, DURING CLAMPING. AFTER TWO (2) MINUTES OF LOW FLOW, AND CUSTOMER SWITCHED TO HAND CRANKING TO ALLOW MORE TIME TO TROUBLESHOOT; NO ALERTS OR ALARMS WAS DISPLAYED. THEN, THE INVOLVED DRIVE UNIT WAS REPLACED WITH A ONE BELONGING TO A NEW PUMP BY THE CUSTOMER. FULL FLOW WAS RE-ESTABLISHED. THE TOTAL TIME OF LOW FLOW/HAND CRANKING WAS APPROXIMATELY SEVEN (7) MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17921247 ↗
• MalfunctionSep 21, 2023No Flow; No Flow

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17787008 ↗
• MalfunctionJun 29, 2023Pumping Problem; Pumping Problem

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17224712 ↗
• MalfunctionJun 16, 2023Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17141511 ↗
• MalfunctionJun 5, 2023Infusion or Flow Problem; Infusion or Flow Problem

  SEE INTIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17058512 ↗
• MalfunctionApr 13, 2023Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16731695 ↗
• MalfunctionOct 31, 2022No Flow; No Flow

  LIVANOVA RECEIVED REPORT THAT ABOUT AFTER 20 MINUTES FROM PROCEDURE STARTED, THERE WAS NO FLOW DESPITE RPM OF THE CENTIFUGAL PUMP 5 (CP5) BEING 3800. FLOW WAS DOWN AND THERE WAS NEGATIVE LINE PRESSURE. THE ORIGINAL THOUGHT WAS A PRESSURE EXCURSION WHICH COULD BE EXCLUDED BY USER BECAUSE AS THEY HAND CRANKED EVERYTHING FLOWED. THE VACUUM WAS REMOVED AND THE CANNULA WAS VERIFIED NOT TO BE OCCLUDED. THE USER TURNED THE CP5 OFF AND BACK ON WHILE CONTINUING TO HAND CRANK AND THE PROBLEM PERSISTED. THE USER TURNED THE DEVICE OFF AND BACK ON AGAIN AND THIS TIME EVERYTHING WENT BACK TO NORMAL AND HAND CRANK WAS STOPPED. THE PROCEDURE COULD BE COMPLETED WITH NO FURTHER ISSUES. REPORTEDLY, THERE WERE NO ALARMS OR ERROR MESSAGES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15697993 ↗
• MalfunctionAug 9, 2022Decreased Pump Speed; Pumping Stopped; Decreased Pump Speed; Pumping Stopped

  LIVANOVA RECEIVED REPORT THAT WHEN TURNED ON AND RPMS INCREASED TO 2000 THE PUMP HEAD OF CENTRIFUGAL PUMP 5 (CP5) DID NOT TURN. THE RPM NUMBER STAYED YELLOW, THEN WENT TO ZERO WITH THE DIAL STILL AT 2000. AT THIS TIME, THE PUMP HEAD STARTED TO TURN VERY SLOWLY. THE RPMS WERE MANUALLY SET DOWN TO ZERO AND BACK UP VERY SLOWLY TO 2000. THE PUMP HEAD STILL ONLY TURNED SLOWLY. THE RPM NUMBER REMAINED YELLOW. I WATCHED FOR A FEW MINUTES AND WITHOUT ME TOUCHING ANYTHING THE PUMP HEAD SPEED INCREASED TO MATCH THE RPM NUMBER AND THEN RAN APPROPRIATELY UNTIL I TURNED IT OFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15189829 ↗

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.