Electrical Remote-Controlled Tubing ClampRecalls & 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
- 85
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 3 models of Electrical Remote-Controlled Tubing Clamp by LivaNova Deutschland GmbH in the FDA's device registry (GUDID). Together they are named in 85 adverse event reports in the FDA's MAUDE database, received between Jan 9, 2017 and Sep 23, 2026 — classified as 85 malfunctions.
The most frequently reported specific device problem is “Difficult to Open or Close” (69 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 Electrical Remote-Controlled Tubing Clamp problems
Device problems
- Difficult to Open or Close69
- Appropriate Device Problem Term/Code Not Available6
- Device Operational Issue3
- Communication or Transmission Problem2
- Device Displays Incorrect Message1
- Difficult or Delayed Positioning1
- Intermittent Communication Failure1
- Loss of Power1
Patient problems
- No Clinical Signs, Symptoms or Conditions73
- No Consequences Or Impact To Patient11
- No Patient Involvement1
Electrical Remote-Controlled Tubing Clamp models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Electrical Remote-Controlled Tubing Clamp 620 mmCONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS52 reports
- Electrical Remote-Controlled Tubing Clamp 500 mmCONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS31 reports
- Electrical Remote-Controlled Tubing Clamp 500 mm (S3)CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS2 reports
Recent Electrical Remote-Controlled Tubing Clamp adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 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 ↗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 ↗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 ↗
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
- S5 Double Roller Pump 852 models · 59 reports
- S5 Mast Roller Pump4 models · 47 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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