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LABSYSTEM™ PRO M0042002021R0Recalls & reported problems

Boston Scientific Corporation · CLEARSIGN™ II Amplifier For LABSYSTEM™ PRO EP Recording System, 40 Channels · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729885849), received between Apr 7, 2022 and Apr 7, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (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

  • Material Integrity Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 7, 2022Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT THE LABSYSTEM PRO CLEARSIGN AMPLIFIER POWER SUPPLY "BLEW UP, AND THAT IT APPEARED TO HAVE EXPLODED". THE ISSUE OCCURRED DURING TRAINING SO THERE WAS NO PATIENT INVOLVEMENT. THE TRAINING WAS DISCONTINUED. THE AMPLIFIER IS NOT EXPECTED TO BE RETURNED AS IT WAS SERVICED ON SITE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14044745 ↗

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.