Electrical Remote-Controlled Tubing Clamp 500 mmRecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 04033817901051), received between Dec 4, 2017 and Sep 14, 2026 — classified as 31 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (29 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Difficult to Open or Close

  LivaNova Deutschland received a report about an error message indicating a defective ERC clamp during procedure.There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50752935 ↗
• MalfunctionDec 19, 2025Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT AFTER COMPLETING PROCEDURE, APPEARED AN ERROR MESSAGE CONCERNING ARTERIAL CLAMP ISSUE ON THE HLM. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23851821 ↗
• MalfunctionJun 23, 2025Difficult to Open or Close; Difficult to Open or Close

  SEE INITIAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22307211 ↗
• MalfunctionMar 25, 2025Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE ERC CLAMP WAS MAKING NOISE DURING PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY. THE DEVICE WAS INVESTIGATED AND IT WAS CLARIFIED THE ALARM 'ARTERIAL CLAMP IS DEFECTIVE' WAS DISPLAYED, WITH NO POSSIBILITY TO OPERATE THE CLAMP. THEREFORE, THE COMPLAINT FROM THE CUSTOMER IS CONFIRMED. INVESTIGATION FOUND CORROSION ON THE CAN CABLE, LIGHTBARRIER CABLE AND CONTROL BOARD. THE SPINDLE WAS BLOCKED INSIDE THE CLAMP HEAD (THIS IS PROBABLY THE REASON WHY THE CUSTOMER HEARD NOISE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21685481 ↗
• MalfunctionMar 13, 2025Difficult to Open or Close; Difficult to Open or Close

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21595501 ↗
• MalfunctionMar 11, 2025Difficult to Open or Close; Difficult to Open or Close

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21570609 ↗
• MalfunctionDec 16, 2024Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT AN ELECTRICAL REMOTE-CONTROLLED TUBING CLAMP (ERC) WAS DEFECTIVE DURING PROCEDURE.THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20938885 ↗
• MalfunctionNov 8, 2024Difficult to Open or Close; Difficult to Open or Close

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20637951 ↗
• MalfunctionJun 24, 2024Difficult to Open or Close; Difficult to Open or Close

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19593242 ↗
• MalfunctionMay 22, 2024Difficult to Open or Close; Difficult to Open or Close

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19370602 ↗
• MalfunctionApr 29, 2024Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 ERC TUBING CLAMP / 500MM DID NOT CLOSE WHILE RUNNING. THE ISSUE OCCURRED DURING TESTING FOLLOWING A REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19199940 ↗
• MalfunctionMar 7, 2024Difficult to Open or Close; Difficult to Open or Close

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18854390 ↗
• MalfunctionFeb 8, 2024Difficult to Open or Close; Difficult to Open or Close

  SEE INTIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18668133 ↗
• MalfunctionJan 4, 2024Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA RECEIVED A REPORT ABOUT A ERC DEVICE FAILED TO WORKING DURING PROCEDURE.THERE IS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18442536 ↗
• MalfunctionNov 2, 2023Difficult to Open or Close; Difficult to Open or Close

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18056918 ↗
• MalfunctionOct 30, 2023Difficult or Delayed Positioning; Difficult to Open or Close; Difficult or Delayed Positioning; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 ERC TUBING CLAMP / 500MM GAVE AN ERROR MESSAGE INDICATING THAT IT IS DEFECTIVE. THE ISSUE OCCURRED DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18028253 ↗
• MalfunctionOct 2, 2023Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 ERC TUBING CLAMP / 500MM GAVE AN ERROR MESSAGE RELATED TO A MALFUNCTION AND THE CLAMP MARK ON THE S5 CONTROL PANEL DISAPPEARED. AFTER CHECKING THE ERROR DISPLAY, THE PROBLEM WAS RESOLVED. THE ISSUE OCCURRED DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17850099 ↗
• MalfunctionSep 14, 2023Communication or Transmission Problem; Communication or Transmission Problem

  LIVANOVA DEUTSCHLAND HAS RECEIVED A REPORT THAT THE CP5 ROTATED AND HAS NO FORWARD FLOW DURING PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY. THROUGH FOLLOW UP WITH THE PERFUSIONIST, LIVANOVA LEARNED THE ERROR OCCURRED POST BYPASS WHEN THE PERFUSIONIST WAS TRYING TO TRANSFUSE PUMP BLOOD VOLUME TO CELL SAVER. THERE WAS NO FLOW BECAUSE THE ERC CLAMPED THE LINE. THE CP5 CONTROL PANEL ALSO DID NOT HAVE THE ERC OPEN/CLOSE ICON. THE PERFUSIONIST TURNED OFF THE S5 AND BACK ON AND THE ERROR MESSAGES WENT AWAY. THE DISPLAYED ERROR MESSAGES WERE ¿ARTERIAL CLAMP IS DEFECTIVE¿ AND ¿ARTERIAL CLAMP DOES NOT OPEN/CLOSE¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744541 ↗
• MalfunctionSep 5, 2023Difficult to Open or Close; Difficult to Open or Close

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682121 ↗
• MalfunctionJun 21, 2023Difficult to Open or Close; Difficult to Open or Close

  SEE INTIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17170967 ↗
• MalfunctionApr 5, 2023Difficult to Open or Close; Noise, Audible; Difficult to Open or Close; Noise, Audible

  LIVANOVA DEUTSCHLAND HAS RECEIVED A REPORT THAT THE ELECTRICAL REMOTE-CONTROLLED TUBING CLAMP (ERC) IS NOT WORKING CORRECTLY DURING A PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16681779 ↗
• MalfunctionDec 16, 2022Difficult to Open or Close; Difficult to Open or Close

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15994225 ↗
• MalfunctionDec 7, 2022Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT SUDDENLY A CLEAR FLUID STARTED LEAKING OUT OF THE CASING OF AN ERC (ELECTRICAL REMOTE-CONTROLLED) TUBING CLAMP AND THE CLAMP NO LONGER RESPONDED TO ANY OPERATIONS. REPORTEDLY, THE ISSUE OCCURRED 3 MONTHS AGO DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15931719 ↗
• MalfunctionNov 4, 2022Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA RECEIVED REPORT THAT A S5 ERC TUBING CLAMP GAVE ERROR MESSAGE "ARTERIAL CLAMP DEFECTIVE" AND OPEN/CLOSE FUNCTION BUTTONS DISAPPEARED FROM THE CP5 CONTROL PANEL DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15734926 ↗
• MalfunctionAug 11, 2022Difficult to Open or Close; Difficult to Open or Close

  LIVANOVA RECEIVED REPORT OF A MALFUNCTIONING ERC CLAMP TRIGGERING AN ERROR MESSAGE ON THE S5 SYSTEM PANEL. REPORTEDLY, THE ERC WILL NOT OPEN OR CLOSE. CUSTOMER CONFIRMED THE ERC CLAMP IS PLUGGED INTO AN APPROPRIATE OUTLET ON THE SIDE OF THE S5 BASE. REPORTEDLY, THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15208172 ↗

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-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-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-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-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-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-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.
• 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-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.