LABSYSTEM™ PRO M00420020340Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729935872), received between Sep 11, 2018 and Mar 11, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Operating System Becomes Nonfunctional” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionNov 1, 2023No Display/Image; Use of Device Problem; No Display/Image; Use of Device Problem

  IT WAS REPORTED THAT DURING A PROCEDURE USING AN LABSYSTEM PRO EP RECORDING SYSTEM - LSPRO 9900 COMPUTER THE SCREEN HAD NO DISPLAY. THE PROCEDURE TOOK PLACE ON (B)(6) 2023 AND WAS CANCELLED DUE TO THIS ISSUE. THERE WERE NO PATIENT COMPLICATIONS. FIELD SERVICE WAS PERFORMED ON THE SYSTEM ON (B)(6) 2023 AND IT WAS FOUND THE CORD TO THE DISPLAY MONITOR WAS LOOSELY CONNECTED. THE CABLE WAS RECONNECTED, AND THE DISPLAY FUNCTIONED AS EXPECTED. THE SYSTEM THEN PASSED ALL TESTING. THE SYSTEM IS NOT EXPECTED TO BE RETURNED AS THERE WAS NO ISSUE FOUND AND THE SITE WILL RETAIN IT FOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18047661 ↗
• MalfunctionSep 15, 2022Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING A PROCEDURE USING A LSPRO RECORDING SYSTEM THERE WERE NO ECG SIGNALS. AT THE START OF THE PROCEDURE NO SIGNALS WERE AVAILABLE. DUE TO THIS THE PROCEDURE WAS CANCELLED AFTER THE PATIENT HAD ALREADY BEEN SEDATED. THERE WERE NO PATIENT COMPLICATIONS. THE LSPRO IS NOT EXPECTED TO BE RETURNED AS IT WILL BE SERVICED ON SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432344 ↗
• MalfunctionApr 12, 2022Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT DURING A PROCEDURE THE LABSYSTEM PRO PC CRASHED/FROZE AND NO ELECTROCARDIOGRAM (ECG) SIGNALS VISUALIZATION WAS POSSIBLE. THE SOFTWARE WAS CLOSED AND RESTARTED TO RESOLVE THE ISSUE. A PHILIPS VITAL MONITOR WAS AVAILABLE FOR SPO2 AND HEARTH RATE VITALS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY PATIENT COMPLICATIONS. THE DEVICE IS CURRENTLY WORKING AND IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14086260 ↗
• MalfunctionMar 29, 2022Application Program Problem; Application Program Problem

  IT WAS REPORTED THAT DURING PREPARATION FOR AN ABLATION PROCEDURE, THE LS PRO CPU WOULD DISPLAY THE WINDOWS IMAGE AND THEN IT WOULD CHANGE TO A BLACK SCREEN AFTER TURNING IT ON. IT WAS NOT POSSIBLE TO BOOT THE LS PRO CPU. THE PATIENT WAS SEDATED AND THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13939716 ↗
• MalfunctionNov 22, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING PREPARATION FOR AN ABLATION PROCEDURE, WHEN THE LABSYSTEM PRO II WORKSTATION WAS TURNED ON TO START THE STUDY CASE, THE MONITORS WERE DIMMED AND DID NOT DISPLAY ANY INFORMATION. THE COMPUTER WAS STARTED UP AND IT BEEPED 4 TIMES. DUE TO THIS ISSUE, THE PROCEDURE WAS CANCELLED. IT IS UNKNOWN IF THE PATENT WAS SEDATED AT THE TIME OF THE EVENT. NO PATIENT CONSEQUENCES WERE REPORTED. NO INFORMATION ABOUT PRODUCT RETURN WAS PROVIDED. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS NOT CANCELLED, BUT WAS DELAYED FOR SOME MINUTES WHILE THEY TROUBLESHOOTED. THE DEVICE WILL NOT BE RETURNED AS THE HOSPITAL OPENED THE CASE TO CLEAN THE DUST INSIDE AND RE-POSITIONED THE MEMORY AND VIDEO CARD. THE DEVICE WAS RETAINED FOR CONTINUED USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12856213 ↗
• MalfunctionNov 9, 2021Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THE CLEARSIGN AMPLIFIER FAILED TO CONNECT TO THE LSPRO PERSONAL COMPUTER (PC) AND THE PROCEDURE WAS CANCELLED DUE TO THE ISSUE. THE PROCEDURE WAS CANCELLED AFTER THE SEDATION OF THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12782771 ↗
• MalfunctionOct 11, 2021Device Displays Incorrect Message; Device Displays Incorrect Message

  A LS PRO RECORDING SYSTEM WAS SELECTED FOR USE. DURING PREPARATION FOR AN ABLATION PROCEDURE, PATIENT ID WAS ENTERED INTO THE SYSTEM AND THE PATIENT WINDOW WAS CLOSED. AN ERROR MESSAGE 'YOU WILL NOT BE ABLE TO USE ANY FEATURES THAT REQUIRE THE AMPLIFIER. CONTACT BOSTON SCIENTIFIC TECHNICAL SUPPORT IF YOU NEED ASSISTANCE' WAS OBSERVED. "CANCEL" OR "OK" WAS PRESSED THE LS PRO APPLICATION WAS CLOSED. THE WORKSTATION WAS REBOOTED AND THE APPLICATION WAS RELAUNCHED, HOWEVER, ERROR WAS NOT RESOLVED. THE AMPLIFIER WAS POWERED ON PROPERLY AND NO ERRORS WERE OBSERVED DURING THE SELF-TEST AND GREEN FLASHING "SYSTEM OK" LED WAS SEEN. ETHERNET CABLE CONNECTION WAS CHECKED WITH NO ISSUES. THE PROCEDURE WAS CANCELLED AT THIS POINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12605560 ↗
• MalfunctionSep 11, 2018Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional

  IT WAS REPORTED THE RECORDING SYSTEM FROZE AND WAS THE ONLY DEVICE IN USE TO MONITOR HEART RHYTHM. A LAB SYSTEM PRO EP RECORDING SYSTEM AND A CRYOABLATION CATHETER WERE SELECTED FOR USE DURING A PARA-HISIAN KENT ABLATION PROCEDURE. ABLATION PROGRESS WAS BEING MONITORED BY READING ENDOCARDIAL SIGNALS. THE LAB SYSTEM PRO WAS THE ONLY DEVICE IN USE TO MONITOR HEART RHYTHM. THE PHYSICIAN WAS ABLATING WHEN THE SCREEN FROZE; THE SCREEN WAS NO LONGER TRANSMITTING INFORMATION IN REAL TIME. DURING THIS TIME, THE PHYSICIAN WAS UNABLE TO SEE CHANGES IN RHYTHM. NO ERROR MESSAGES POPPED UP. THE FREEZE LASTED 10 SECONDS. THE FREEZE WAS RESOLVED BY PRESSING THE F8 BUTTON SEVERAL TIMES TO CREATE A NEW EVENT. WHEN THE SIGNALS FINALLY UPDATED, THE PHYSICIAN SAW ATRIOVENTRICULAR (AV) BLOCK; THEREFORE, HE STOPPED ABLATING AND THE AV BLOCK DISAPPEARED. IT WAS UNKNOWN HOW LONG THE AV BLOCK LASTED, AS IT BEGAN WHEN THE SCREEN WAS FROZEN. THE AV BLOCK WAS TRANSIENT AND DID NOT REQUIRE INTERVENTION.

  Patient problems: Complete Heart Block

  MAUDE report 7864907 ↗