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N/A (REF 401904)Recalls & reported problems

Innovative Health LLC · Livewire Steerable Diagnostic EP Catheter 95 cm Super Lrg Curl Curve 20 Electrodes 2-10-2 mm Spacing 7F · 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 10841898111723), received between May 15, 2023 and May 15, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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

  • Deformation Due to Compressive Stress1
  • Material Separation1
  • Stretched1

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.

  • MalfunctionMay 15, 2023Material Separation; Stretched; Deformation Due to Compressive Stress; Material Separation; Stretched; Deformation Due to Compressive Stress

    THIS DEVICE WAS REPORTED TO BE WORKING PROPERLY DURING A PROCEDURE UNTIL AN ISSUE WITH THE DEFLECTION WAS NOTED. AFTER PULLING OUT THE CATHETER, THE DEVICE SHAFT WAS REPORTED TO SEPARATE. THE DEVICE WAS INTACT WHILE IN USE, AND NO PATIENT INJURIES WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16935253 ↗

Other Catheter, Recording, Electrode, Reprocessed devices

All Catheter, Recording, Electrode, Reprocessed devices →

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