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Livewire™ 402022Recalls & reported problems

St. Jude Medical Cardiovascular Division · Steerable Electrophysiology Catheter · 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 05414734202763), received between Jun 6, 2023 and Jun 7, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Signal Artifact/Noise” (2 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

Device problems

  • Signal Artifact/Noise2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

  • MalfunctionJun 7, 2023Signal Artifact/Noise; Signal Artifact/Noise

    DURING THE PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, NOISE ISSUES RESULTING IN MULTIPLE EXCHANGES WHICH CAUSED PROCEDURAL DELAYS. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE CATHETER WAS INSERTED INTO THE HEART AND CONNECTED TO THE CONNECTING CABLE BUT NOISE WAS NOTED ON THE ELECTRIC POTENTIALS 1-2 AND ELECTRIC POTENTIAL COULD NOT READ. THE CONNECTING CABLE WAS EXCHANGED WITH NO RESOLUTION. THE CATHETER WAS EXCHANGED TO A SECOND ONE OF SAME LOT NUMBER WITH NO RESOLUTION. THE CATHETER WAS REPLACED TO A THIRD ONE AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17077734 ↗
  • MalfunctionJun 6, 2023Signal Artifact/Noise; Signal Artifact/Noise

    DURING THE PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, NOISE ISSUES RESULTING IN MULTIPLE EXCHANGES WHICH CAUSED PROCEDURAL DELAYS. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE CATHETER WAS INSERTED INTO THE HEART AND CONNECTED TO THE CONNECTING CABLE BUT NOISE WAS NOTED ON THE ELECTRIC POTENTIALS 1-2 AND ELECTRIC POTENTIAL COULD NOT READ. THE CONNECTING CABLE WAS EXCHANGED WITH NO RESOLUTION. THE CATHETER WAS EXCHANGED TO A SECOND ONE OF SAME LOT NUMBER WITH NO RESOLUTION. THE CATHETER WAS REPLACED TO A THIRD ONE AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17075666 ↗

Other CATHETER, STEERABLE devices

All CATHETER, STEERABLE devices →

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