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N/A (REF 401932)Recalls & reported problems

Innovative Health LLC · Livewire Steerable Diagnostic EP Catheter 95 cm Super Lrg Curl Curve 20 Electrodes 2-8-2-(60)-2-8-2 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 10841898111808), received between Aug 3, 2022 and Aug 3, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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

  • Difficult to Remove1

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.

  • MalfunctionAug 3, 2022Difficult to Remove; Difficult to Remove

    THIS DEVICE'S STEERING MECHANISM WAS REPORTED TO FAIL AND WOULD NOT STRAIGHTEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15156950 ↗

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.