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LABSYSTEM™ PRO M0042001267R0Recalls & reported problems

Boston Scientific Corporation · CLEARSIGN™ Amplifier For LABSYSTEM™ PRO EP Recording System, 80 Channels · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729883302), received between Sep 2, 2020 and Mar 18, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (1 report).

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

Device problems

  • Device Displays Incorrect Message1
  • Failure to Power Up1
  • Operating System Becomes Nonfunctional1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 18, 2022Device Displays Incorrect Message; Operating System Becomes Nonfunctional; Device Displays Incorrect Message; Operating System Becomes Nonfunctional

    IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE THE LS PRO WORKSTATION WAS NOT CONNECTING TO THE CLEARSIGN AMPLIFIER. THE "NOT FINDING AMPLIFIER / AMP NOT CONNECTING PROPERLY" ERROR MESSAGE WAS DISPLAYED DURING THE PROCEDURE. THE POWER ON INDICATOR WAS ILLUMINATED IN SOLID GREEN AND THE SYSTEM OK INDICATOR WAS ILLUMINATED BLINKING AMBER. LABORATORY STAFF WAS INSTRUCTED TO CHECK THE LOG FILES AND A VOLTAGE PROBLEM WAS LISTED IN THE FILES. THE ISSUE WAS NOT RESOLVED AND THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE HAS BEEN RETURNED FOR ANALYSIS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13805343 ↗
  • MalfunctionSep 2, 2020Failure to Power Up; Failure to Power Up

    IT WAS REPORTED HAT THE PROCEDURE WAS CANCELED. IT WAS REPORTED THAT A CLEARSIGN AMP, 80 WAS SELECTED FOR A PROCEDURE. IT WAS NOTED THAT THE AMP DID NOT TURN ON AND THE ISSUE WAS UNABLE TO BE RESOLVED. IT WAS NOT REPORTED IF THE PATIENT WAS SEDATED PRIOR TO THIS ISSUE BUT NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10482836 ↗

Other AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL devices

All AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.