LABSYSTEM PRORecalls & reported problems across all models

We found 12 models of LABSYSTEM PRO by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 46 adverse event reports in the FDA's MAUDE database, received between Sep 11, 2018 and Jul 29, 2026 — classified as 46 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (8 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

Most reported LABSYSTEM PRO problems

LABSYSTEM PRO models

12 models, most reported first. Each model has its own page with its reports, recalls and device details.

• LABSYSTEM™ PRO M00420020220

  AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL
  16 reports
• LABSYSTEM™ PRO M00420020340

  COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  10 reports
• LABSYSTEM™ PRO M00420020210

  AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL
  4 reports
• LABSYSTEM™ PRO M00420020230

  AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL
  3 reports
• LABSYSTEM™ PRO M0042002022R0

  AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL
  3 reports
• LABSYSTEM™ PRO M0042001267R0

  AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL
  2 reports
• LABSYSTEM™ PRO M0042002034R0

  COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  2 reports
• LABSYSTEM™ PRO M00420020810

  Computer, diagnostic, programmable
  2 reports
• LABSYSTEM™ PRO M0042001267H0

  AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL
  1 report
• LABSYSTEM™ PRO M00420020290

  COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  1 report
• LABSYSTEM™ PRO M0042002021R0

  AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL
  1 report
• LABSYSTEM™ PRO M00420020240

  AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL
  1 report

Recent LABSYSTEM PRO adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2026Signal Artifact/Noise

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50077371 ↗
• 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 ↗
• MalfunctionJul 10, 2026Device Displays Incorrect Message; Reset Problem

  IT WAS REPORTED THAT THE AMPLIFIER BROKE DOWN MID-CASE. DURING A PROCEDURE, A LABSYSTEM PRO CLEARSIGN II AMPLIFIER WAS SELECTED FOR USE. UPON SYSTEM STARTUP, THE ERROR MESSAGE "BEFORE CONTINUING YOU MUST RESET THE AMPLIFIER" WAS DISPLAYED. TROUBLESHOOTING WAS PERFORMED, INCLUDING TWO HARD RESETS AND POWERING ON THE SYSTEM USING THREE TO FOUR DIFFERENT STARTUP SEQUENCES; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. AFTER THE FUSE BOX WAS REMOVED, THE LABSYSTEM PRO WAS SUCCESSFULLY RESTARTED. DESPITE THE SUCCESSFUL RESTART, THE PROCEDURE WAS SUBSEQUENTLY CANCELLED WHILE THE PATIENT REMAINED UNDER GENERAL ANESTHESIA. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25781212 ↗
• 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 ↗
• MalfunctionSep 25, 2025Defective Device; Data Problem; Defective Device; Data Problem

  THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION. IT WAS REPORTED THAT DURING THE PROCEDURE, AN LABSYSTEM PRO CLEARSIGN II AMPLIFIER WAS SELECTED FOR USE. IT WAS FOUND THAT THE SAP OF THE DEVICE WAS FLASHING YELLOW AND DATA COULD NOT BE EXPORTED. THERE WAS NO ERROR MESSAGE DISPLAYED. EQUIPMENT NEEDS REPLACEMENT. THIS ISSUE LED TO THE PROCEDURE BEING CANCELLED/RESCHEDULED. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23151066 ↗
• MalfunctionMar 11, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION. IT WAS REPORTED THAT A LABSYSTEM PRO EP RECORDING SYSTEM CPU WAS SELECTED FOR USE. AN ERROR MESSAGE ABOUT FULL HARD DISK WAS DISPLAYED. NO OTHER INFORMATION WAS PROVIDED. THE PROCEDURE WAS CANCELLED/RESCHEDULED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS. NO INFORMATION IF THE DEVICE WILL RETURN FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21575382 ↗
• MalfunctionJan 14, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED POST PATIENT SEDATION. A LSPRO WAS SELECTED FOR USE IN AN ATRIAL FIBRILLATION PROCEDURE. LOCAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT. THE LSPRO WAS NOT CONNECTED CORRECTLY BY THE USER DURING PREPARATION AND THE PROCEDURE WAS CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21154995 ↗
• MalfunctionSep 25, 2024Failure to Power Up; Connection Problem; Failure to Power Up; Connection Problem

  THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION. DURING AN EVENT, THE LABSYSTEM PRO EP RECORDING SYSTEM - CLEARSIGN II AMPLIFIER WAS SELECTED FOR USE. IT WAS REPORTED THAT AMPLIFIER WAS NOT FUNCTIONING. THE AMPLIFIER WAS STOPPED RESPONDING MID-PROCEDURE. IT WAS NOTED THAT HEPARINE SALINE FLUID SPLASHED ONTO ELECTRICAL EQUIPMENT PENDANT AND POTENTIALLY ENTERED A POWER SOCKET AND CIRCUIT BREAKER, THUS, LOSING POWER TO ALL EQUIPMENT. THE EQUIPMENT WAS REBOOTED WITHOUT ISSUES EXCEPT FOR THE CLEARSIGN AMPLIFIER. CONNECTION BETWEEN WORKSTATION COULD NOT BE RESTORED DESPITE ALL TROUBLESHOOTING SUGGESTED BY TECHNICAL SUPPORT. DUE TO THIS THE PROCEDURE WAS CANCELLED. PATIENT HAD BEEN SEDATED AT THE TIME OF CANCELLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20306967 ↗
• MalfunctionAug 9, 2024Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional

  THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION. IT WAS REPORTED THAT DURING A PROCEDURE A LABSYSTEM PRO EP RECORDING SYSTEM WAS SELECTED FOR USE. THE SYSTEM IS SHOWING INSTABILITY AND FREEZES VERY OFTEN. PROCEDURE WAS NOT ABLE TO BE COMPLETED DUE TO THIS EVENT AND HAD TO BE CANCELLED/RESCHEDULED. NO FURTHER INFORMATION WAS PROVIDED. EQUIPMENT WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19949155 ↗
• 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 ↗

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