LABSYSTEM™ PRO M00420020220Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08714729884897), received between Dec 9, 2020 and Jul 13, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (4 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, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2026Communication or Transmission Problem; Device Sensing Problem; Reset Problem

  IT WAS REPORTED THAT ALL ELECTROCARDIOGRAM (ECG) LEADS WERE LOST IN THE MIDDLE OF THE CASE. THE ERROR MESSAGE "BEFORE CONTINUING YOU MUST RESET THE AMPLIFIER" WAS DISPLAYED, AND THE AMPLIFIER COULD NOT BE RECONNECTED TO THE SYSTEM. SUBSEQUENTLY, THE PROCEDURE WAS CANCELLED. THE PATIENT WAS UNDER GENERAL ANESTHESIA. DURING A PROCEDURE, A LABSYSTEM PRO CLEARSIGN II AMPLIFIER WAS SELECTED FOR USE. IN THE MIDDLE OF THE CASE, IT WAS NOTED THAT ALL ECG LEADS WERE LOST. THE ERROR MESSAGE "BEFORE CONTINUING YOU MUST RESET THE AMPLIFIER" WAS DISPLAYED. TROUBLESHOOTING WAS PERFORMED; THE CABLE WAS REPLACED, THE AMPLIFIER WAS SHUT DOWN AND WAS DISCONNECTED FROM THE POWER CORD. AN ATTEMPT WAS ALSO MADE TO REPROGRAM NETWORK INTERFACE CARD 1 (NIC1) ON THE WORKSTATION TO RESTORE CONNECTION TO THE AMPLIFIER; HOWEVER, THE PROBLEM WAS NOT RESOLVED. THE AMPLIFIER COULD NOT BE RECONNECTED TO THE SYSTEM. SUBSEQUENTLY, THE PROCEDURE WAS CANCELLED, WITH PART OF THE PROCEDURE COMPLETED WHEN THE PHYSICIAN DECIDED TO DISCONTINUE THE PROCEDURE BEFORE ITS COMPLETION. NO PATIENT COMPLICATIONS WERE REPORTED. THE PROBLEM WAS SUBSEQUENTLY RESOLVED FOLLOWING THE INTERVENTION OF A FIELD SERVICE ENGINEER. BASED ON T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25803464 ↗
• MalfunctionApr 7, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE EQUIPMENT POWERED ON; HOWEVER, THE AMPLIFIER COULD NOT BE CONNECTED. THIS IS BEING REPORTED FOR CANCELLATION OF THE PROCEDURE POST SEDATION. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE EQUIPMENT POWERED ON; HOWEVER, THE AMPLIFIER COULD NOT BE CONNECTED. DURING REMOTE SUPPORT, THE EQUIPMENT WAS CONFIRMED TO BE PROPERLY CONNECTED. A MANUAL CONNECTION WAS ATTEMPTED THROUGH THE APPLICATION, BUT THE CONNECTION COULD NOT BE ESTABLISHED. THE ETHERNET CABLE WAS ALSO REPLACED; HOWEVER, THE PROBLEM WAS NOT RESOLVED. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS NOT COMPLETED, AND THE PATIENT WAS SEDATED AT THE TIME THE PROCEDURE WAS CANCELLED. IT IS UNKNOWN WHETHER THE PATIENT WAS SEDATED WITH LOCAL OR GENERAL ANESTHESIA. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800532 ↗
• MalfunctionJan 29, 2026Failure to Power Up

  IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO START AND INSTEAD BOOTED INTO A BLUE BIOS SCREEN, CONSEQUENTLY, THE PROCEDURE WAS CANCELLED. THE STATUS OF THE PATIENT'S SEDATION WHEN THE CANCELLATION OCCURRED IS UNKNOWN. A LABSYSTEM PRO CLEARSIGN II AMPLIFIER WAS SELECTED FOR USE. DURING PREPARATION, THE DEVICE WAS UNABLE TO START AND INSTEAD BOOTED INTO A BLUE BIOS SCREEN, CONSEQUENTLY, THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS. IT IS NOT KNOWN WHETHER THE DEVICE WILL BE RETURNED FOR ANALYSIS. THIS IS BEING REPORTED FOR CANCELLATION OF THE PROCEDURE WITH SEDATION STATUS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209751 ↗
• MalfunctionNov 26, 2025Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THE IC SIGNALS WERE SEVERELY DISRUPTED AND UNREADABLE. SUBSEQUENTLY, THE PROCEDURE WAS CANCELLED. DURING A PULSESELECT PULSED FIELD ABLATION (MEDTRONIC) PROCEDURE TO TREAT ATRIAL FIBRILLATION, A LABSYSTEM PRO CLEARSIGN AMPLIFIER WAS USED. IT WAS OBSERVED THAT THE IC SIGNALS WERE SEVERELY DISRUPTED AND UNREADABLE ACROSS ALL ABLATION CATHETER DIPOLES. THERE WERE NO PROBLEMS NOTED WITH THE ECG AND CORONARY SINUS CATHETER TRACE. BOTH THE CABLE AND THE PULSESELECT ABLATION CATHETER WERE REPLACED, BUT ARTIFACTS WERE STILL NOTED. THE LSPRO CONNECTION BOX WAS THEN REPLACED, BUT THE PROBLEM WAS NOT RESOLVED. CONSEQUENTLY, THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE DEVICE WILL NOT BE RETURNED, AS A FIELD SERVICE ENGINEER (FSE) WAS SCHEDULED TO PERFORM TESTING ON THE CLEARSIGN AMPLIFIER. THIS IS BEING REPORTED FOR CANCELLATION OF THE PROCEDURE POST SEDATION. IT WAS FURTHER REPORTED THAT THE PATIENT WAS UNDER GENERAL ANESTHESIA FOR THE PROCEDURE; HOWEVER, THE PROCEDURE WAS COMPLETED USING THE ORIGINAL AMPLIFIER DESPITE MULTIPLE ARTIFACTS IN THE TRACINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658732 ↗
• MalfunctionOct 16, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT AN ERROR MESSAGE APPEARED AT STARTUP INDICATING THE AMPLIFIER WAS NOT FUNCTIONING. SUBSEQUENTLY THE PROCEDURE WAS CANCELLED, AND IT IS UNKNOWN IF SEDATION WAS PERFORMED. DURING PREPARATION FOR A PROCEDURE, A LABSYSTEM PRO WAS SELECTED FOR USE. UPON START-UP AN ERROR DISPLAYED INDICATING THE SYSTEM WAS CONFIGURED TO USE THE AMPLIFIER, BUT IT WAS NOT FUNCTIONING PROPERLY. THE AMPLIFIER WAS RESTARTED, AND AN ORANGE LED BEGAN BLINKING. THE CABLES WERE DISCONNECTED AND RECONNECTED, AND THE SYSTEM WAS RESTARTED AGAIN WITHOUT RESOLVE. NEXT THE ETHERNET CABLE WAS REPLACED, AND THE SYSTEM WAS REBOOTED ONCE MORE. AS THE ISSUE COULD NOT BE RESOLVED, THE PROCEDURE WAS CANCELLED. IT IS UNKNOWN IF SEDATION WAS PERFORMED. THE DEVICE WAS REPAIRED ON SITE AND WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23311176 ↗
• MalfunctionJul 29, 2024Communication or Transmission Problem; Communication or Transmission Problem

  THE CLEARSIGN AMPLIFIER WAS SELECTED FOR USE DURING THE PULMONARY VEIN ISOLATION PROCEDURE. IT WAS REPORTED THAT THEY HAD RECURRENT LOSS OF CONNECTION BETWEEN THE AMPLIFIER AND THE LABSYSTEM COMPUTER. THAT HAPPENED DURING THE PROCEDURE AS WELL, AND AT SOME POINT, THE PHYSICIAN DECIDED TO STOP THE PROCEDURE AND REPEAT IT ONCE THE CONNECTION WAS FIXED. THE PATIENT HAD BEEN SEDATED AT THE TIME OF CANCELLATION. NO PATIENT COMPLICATION WAS REPORTED. DEVICE WILL NOT BE RETURNED AS ONSITE WORK REPAIR WAS ORDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19850817 ↗
• MalfunctionJun 26, 2024Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT THE POWER CABLE FROM THE AMPLIFIER TO THE ISOLATION TRANSFORMER WAS DAMAGED AND CAUSED A FIRE. THE ISOLATION TRANSFORMER WAS SWITCHED ON, MADE A CLICK, AND THE POWER CABLE STARTED A FIRE. NO PATIENT WAS INVOLVED. THE OUTCOME OF THE EVENT IS NOT KNOWN. IT IS ALSO UNKNOWN IF DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19619172 ↗
• MalfunctionJun 11, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A CLEARSIGN AMPLIFIER FOR LABSYSTEM PRO EP RECORDING SYSTEM WAS SELECTED FOR USE. A POWER CABLE OF THE CLEARSIGN HAS A SHORT-CIRCUIT WHEN TURNING ON THE ISOLATION TRANSFORMER (SPARKS WERE SEEN BY THE HEALTH CARE PROVIDER). THE ISOLATION TRANSFORMER COULD BE AFFECTED. FIELD SERVICE WAS REQUESTED TO CHECK THE ELECTRICAL FUNCTIONALITY OF ALL THE CE CONNECTED TO THE ISOLATION TRANSFORMER. PROCEDURE WAS CANCELLED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM RESPONSE TO GFE TW# (B)(4). IT WAS CONFIRMED THAT THIS EVENT IS A DUPLICATE TO COMPLAINT RECORD. A FIRE WAS CAUSED WHEN THE ISOLATION TRANSFORMER WAS TURNED ON. THE FIRE WAS STOPPED BUT THE POWER CABLE WAS DAMAGED. THE PATIENT HAD NOT YET ARRIVED WHEN THE ISSUE OCCURRED. THEREFORE, NO PATIENT WAS INVOLVED AT THE TIME OF PROCEDURE CANCELLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19511342 ↗
• MalfunctionMay 23, 2024Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT A CLEARSIGN II AMPLIFIER PRESENTED AN ISSUE. THERE WAS A LOT OF NOISE ON THE EGM SIGNALS. TROUBLESHOOTING WAS ATTEMPTED TO SOLVE THE ISSUE LIKE REPLACING THE CATHETER, THE CONNECTION CABLE, THE JUNCTION BOX, HOWEVER, THE ISSUE PERSISTED. THE PROCEDURE HAD TO BE CANCELLED DUE TO THIS EVENT. IT IS UNKNOWN IF THE PATIENT WAS PRESENT AND SEDATED BY THE TIME THE ISSUE OCCURRED. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED FOR LABORATORY ANALYSIS. IT WAS FURTHER CONFIRMED THAT THE PATIENT WAS SEDATED WHEN THE PROCEDURE WAS CANCELLED. A NON-BOSTON SCIENTIFIC CATHETER WAS USED WITH THE LABSYSTEM PRO CLEARSIGN II AMPLIFIER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19382760 ↗
• MalfunctionAug 31, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, A LABSYSTEM PRO CLEARSIGN II AMP WAS SELECTED FOR USE. DURING THE BEGINNING OF THE PACING, THE UNIT WILL PACE A FEW BEATS AND THEN IT SHUT DOWN. NO PATIENT COMPLICATIONS OCCURRED. PROCEDURE WAS NOT ABLE TO BE COMPLETED DUE TO THIS EVENT. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17666094 ↗
• MalfunctionAug 21, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT A CLEARSIGN II AMP PRESENTED A HIGH IMPEDANCE ISSUE DURING THE PROCEDURE. THE PROCEDURE WAS CANCELED DUE TO THIS ISSUE. NO PATIENT COMPLICATIONS. FUNCTIONAL TESTS DEMONSTRATED THAT BOTH LS PRO AND MICROPACE WERE WORKING APPROPRIATELY AFTER THE ISSUE. THE PRODUCT WILL NOT RETURN FOR FURTHER ANALYSIS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17589686 ↗
• MalfunctionAug 16, 2023Failure to Power Up; Failure to Power Up

  DURING PROCEDURE, AN LABSYSTEM PRO CLEARSIGN II AMP, 80 CHANNELS WAS SELECTED FOR USE. IT WAS REPORTED THAT AMPLIFIER AND THE SOFTWARE COULD NOT BE TURNED ON. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE PATIENT IS STABLE, NO PATIENT COMPLICATION OR OTHER ADDITIONAL INTERVENTION REPORTED. THE DEVICE WON'T BE RETURNED SINCE THE ISSUE WAS SOLVED ON SITE, THE SOFTWARE RAN NORMALLY, AND THE AMPLIFIER WAS MAINTAINED AND THERE ARE NOT DEVICE COMPONENTS TO BE RETURNED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17558648 ↗
• MalfunctionJun 21, 2023Power Conditioning Problem; Power Conditioning Problem

  DURING PROCEDURE, A CLEARSIGN II AMP, 80 CHANNELS WAS SELECTED FOR USE. IT WAS REPORTED THAT SIGNAL INTERFERENCE OF BODY SURFACE WAS FOUND. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS ISSUE. THE PATIENT IS STABLE, NO PATIENT COMPLICATION OR OTHER ADDITIONAL INTERVENTION REPORTED. UNKNOWN IF PRODUCT IS GOING TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17175427 ↗
• MalfunctionJun 8, 2023Signal Artifact/Noise; Defective Device; Signal Artifact/Noise; Defective Device

  IT WAS REPORTED THAT DURING A PROCEDURE A CLEARSIGN II AMP, 80 CHANNELS WAS SELECTED FOR USE. THE QUADRI PROBES WERE NOT RECOGNIZED, AND A NOISE ARTIFACT WAS DETECTED. THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED. THIS REPORT IS BEING SENT DUE TO THE PROCEDURE CANCELLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17087905 ↗
• MalfunctionMay 23, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT PRIOR TO A PROCEDURE A CLEARSIGN II AMP, 80 CHANNELS PRESENTED AN ERROR AT THE TIME TO START IT. THE PROCEDURE WAS CANCELLED DUE TO THE ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED. DEVICE RETURN STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14470921 ↗
• MalfunctionDec 9, 2020Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE CLEARSIGN II AMP WAS SELECTED TO BE USED IN A PROCEDURE. HOWEVER IT WAS NOTED THAT THAT DURING PREPARATION THE PHYSICIAN FOUND A CABLE CONNECTION ISSUE. THE PROCEDURE WAS CANCELED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10977618 ↗