Electrical Remote-Controlled Tubing Clamp 620 mmRecalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 04033817901068), received between Jan 9, 2017 and Sep 23, 2026 — classified as 52 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (38 reports).

13 other recalls cover devices cleared under the same FDA submission (K071318); 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 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Unstable

  LivaNova Deutschland received a report of an Electrical Remote-Controlled (ERC) Tubing Clamp which was found to be defective and not working properly. The event occurred during priming.There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50866684 ↗
• MalfunctionSep 16, 2026Difficult to Open or Close

  LivaNova Deutschland received a report that the S5 HLM ERC experienced a Timeout error during service.There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50785642 ↗
• MalfunctionFeb 27, 2026Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE ELECTRONIC REMOTE CLAMP ERC INSTALLED ON S5 HLM SYSTEM SHOWED AN ERROR MESSAGE INDICATING THAT THE DEVICE WAS DEFECTIVE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470077 ↗
• MalfunctionFeb 6, 2026Intermittent Communication Failure

  LIVANOVA DEUTSCHLAND RECEIVED REPORT OF AN ERROR MESSAGE CONCERNING AN ELECTRICAL REMOTE-CONTROLLED (ERC) TUBING CLAMP. THE ISSUE OCCURRED DURING SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279547 ↗
• MalfunctionDec 18, 2025Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT OF A TIMEOUT OF ELECTRICAL REMOTE-CONTROLLED (ERC) TUBING CLAMP, WITHOUT BEING FUNCTIONAL. REPORTEDLY, THE CENTRIFUGAL PUMP DRIVE EXPERIENCED AN INTERNAL CONTROL ERROR DURING THE EVENT. THE ISSUE OCCURRED DURING SET-UP OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838518 ↗
• MalfunctionDec 18, 2025Difficult to Open or Close; Difficult to Open or Close

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23836166 ↗
• MalfunctionDec 17, 2025Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT OF A DEFECTIVE ELECTRICAL REMOTE-CONTROLLED (ERC) TUBING CLAMP. AN ERROR MESSAGE WAS DISPLAYED ONTO THE HEART-LUNG MACHINE UNIT. THE EVENT OCCURRED DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23826017 ↗
• MalfunctionNov 28, 2025Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT OF AN ARTERIAL CLAMP WHICH COULD NOT PROPERLY CLOSE AS CONSEQUENCE OF A REDUCTION LEVEL OF BLOOD INTO THE RESERVOIR (STOP-LINK FUNCTION). A CENTRIFUGAL PUMP WITH ITS CONTROL PANEL WAS USED DURING THE PROCEDURE. REPORTEDLY, AIR ENTERED INTO THE PUMP HEAD AND THE PROCEDURE HAD TO BRIEFLY BE INTERRUPTED IN ORDER TO REMOVE AIR FROM THE SYSTEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23669559 ↗
• MalfunctionOct 17, 2025Communication or Transmission Problem; Communication or Transmission Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT OF AN ELECTRONIC REMOTE CONTROL CLAMP (ERC) WHICH COULD NOT WORK PROPERLY. THE EVENT OCCURRED DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23325880 ↗
• MalfunctionAug 27, 2025Difficult to Open or Close; Difficult to Open or Close

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22904606 ↗
• MalfunctionAug 19, 2025Difficult to Open or Close; Difficult to Open or Close

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22836960 ↗
• MalfunctionJul 11, 2025Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND HAS RECEIVED A REPORT THAT, DURING IN-SERVICE, THE CP5 DISPLAYED ''ELECTRONIC CLAMP FAILURE'' ALARM AND IT WAS NOT POSSIBLE TO CLEAR IT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22477686 ↗
• MalfunctionMay 29, 2025Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT AN ELECTRICAL REMOTE-CONTROLLED TUBING CLAMP (ERC) HAD A FAILURE DURING SERVICE ACTIVITY. IN DETAIL, THE CLAMP ICON DISAPPEARED FROM THE CP5 CONTROL SCREEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22103385 ↗
• MalfunctionMay 21, 2025Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, DURING SET-UP THE CLAMP ICON WAS DISPLAYED ON THE CP5 CONTROL PANEL. HOWEVER, ICON DISAPPEARED WHEN PREPARATION WAS COMPLETE. THE MEDICAL TEAM ELECTED TO NOT REBOOT THE MACHINE BECAUSE THE CASE WAS ABOUT TO START. THE PROBLEM WAS NOT REPRODUCIBLE AFTER THAT. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061132 ↗
• MalfunctionMay 13, 2025Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE ELECTRICAL REMOTE-CONTROLLED TUBING CLAMP DISPLAYED ERROR MESSAGE "OCCLUDER IS BROKEN" DURING SETUP - AFTER PACKAGE OPENED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22009309 ↗
• MalfunctionMar 14, 2025Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, DURING PROCEDURE, THE ELECTRICAL REMOTE-CONTROLLED TUBING CLAMP WAS DEFECTIVE. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21604252 ↗
• MalfunctionDec 5, 2024Difficult to Open or Close; Difficult to Open or Close

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20851630 ↗
• MalfunctionNov 27, 2024Difficult to Open or Close; Difficult to Open or Close

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20796433 ↗
• MalfunctionSep 19, 2024Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT AN ELECTRICAL REMOTE-CONTROLLED TUBING CLAMP GAVE AN ERROR MESSAGE RELATED TO ITS FAILURE ("ARTERIAL CLAMP IS DEFECTIVE") DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20255288 ↗
• MalfunctionAug 30, 2024Difficult to Open or Close; Difficult to Open or Close

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20106353 ↗
• MalfunctionJul 18, 2024Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 ERC TUBING CLAMP / 620MM DISPLAYED AN ERROR RELATED TO DEFECTIVE UNIT AND WAS SQUEAKY. THE ISSUE OCCURRED AT SET-UP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19771634 ↗
• MalfunctionJul 8, 2024Difficult to Open or Close; Difficult to Open or Close

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19687607 ↗
• MalfunctionJul 8, 2024Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 ERC TUBING CLAMP / 620MM GAVE A "ARTERIAL CLAMP DEFECTIVE" ERROR MESSAGE AND THE OPEN/CLOSE KEY BUTTONS DISAPPEARED FROM CP5 CONTROL UNIT DISPLAY, THEREFORE THE CLAMP COULD NOT BE CONTROLLABLE. THE ISSUE OCCURRED DURING REPAIR ACTIVITY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19687555 ↗
• MalfunctionJun 27, 2024Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 ERC TUBING CLAMP / 620MM WAS DEFECTIVE. NO ADDITIONAL INFORMATION IS AVAILABLE. THE ISSUE OCCURRED DURING SETUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19623688 ↗
• MalfunctionApr 16, 2024Difficult to Open or Close; Difficult to Open or Close

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19114621 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071318. One submission often covers many models, so check the product and lot details in each record.

• Z-1119-2020 · Jan 28, 2019 · Terminated
  LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594 Product Usage: The S5 System is used to perform, control and monitor extracorp
• Z-2866-2016 · Aug 25, 2016 · Terminated
  Stckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console Product Usage: The Stckert S5 System is intended to be used during cardiopulmonary bypa
• Z-0856-2014 · Dec 4, 2013 · Terminated
  S5/C5 Heart-lung machine 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-0142-2014 · Sep 24, 2013 · Terminated
  S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6)
• Z-0273-2013 · Sep 19, 2012 · Terminated
  S5 Mast Roller Pump 85, Item Number: 10-88-60 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
• Z-0271-2013 · Sep 19, 2012 · Terminated
  S5 Single Roller Pump 150, Item Number: 10-80-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
• Z-0274-2013 · Sep 19, 2012 · Terminated
  S5 Mast Roller Pump 150, Item Number: 10-88-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
• Z-0275-2013 · Sep 19, 2012 · Terminated
  Sorin C5 Perfusion System, Item number 58-00-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
• Z-0272-2013 · Sep 19, 2012 · Terminated
  S5 Double Roller Pump 85, Item Number: 10-85-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
• Z-1326-2012 · Feb 23, 2012 · Terminated
  S5 Double Roller Pump 85 The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours.
• Z-1327-2012 · Feb 23, 2012 · Terminated
  Control panel for mast roller pump 150/85 The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) ho
• Z-1325-2012 · Feb 23, 2012 · Terminated
  S5 Single Roller Pump 150 The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours.
• Z-1328-2012 · Feb 23, 2012 · Terminated
  Control panel for mast roller pump 85 The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours.