Livewire™ 402151Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05414734200240), received between Aug 14, 2020 and May 6, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Electrical Shorting” (3 reports).

1 other recall cover devices cleared under the same FDA submission (P960016); they may or may not involve this specific model.

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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2024Electrical Shorting; Electrical Shorting

  THIS REPORT IS TO ADVISE OF A SHORT CIRCUIT FOUND IN THE CATHETER DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19249484 ↗
• MalfunctionMay 3, 2024Electrical Shorting; Electrical Shorting

  THIS REPORT IS TO ADVISE OF A SHORT CIRCUIT NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19242896 ↗
• MalfunctionJul 28, 2023Electrical Shorting; Electrical Shorting

  THIS REPORT IS TO ADVISE OF A SHORT CIRCUIT THAT WAS NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17419824 ↗
• InjuryAug 14, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA, A STEAM POP OCCURRED IN THE RIGHT ATRIUM RESULTING IN ATRIOVENTRICULAR (AV) HEART BLOCK. ABLATION WAS CONDUCTED WITH THE AMPERE AND THE POWER SETTINGS WERE AT 55 W USING TEMPERATURE CONTROL. AT THE TIME OF STEAM POP, THE TEMPERATURE WAS 52 DEGREES. THE ABLATION PROCEDURE WAS STOPPED SINCE THE PATIENT DEVELOPED TRANSIENT ATRIOVENTRICULAR (AV) BLOCK DUE TO THE STEAM POP. THE PATIENT WAS TRANSFERRED FOR OBSERVATION AND SINUS RHYTHM WAS RESTORED WITHOUT ANY INTERVENTION. THE PATIENT IS IN STABLE CONDITION.

  Patient problems: Complete Heart Block

  MAUDE report 10409674 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P960016. One submission often covers many models, so check the product and lot details in each record.

• Z-2313-2008 · Jun 5, 2008 · Terminated
  The St. Jude Medical Livewire TC" Ablation Catheter, 8mm Tip w/Thermocouple & Thermistor REF 402196, Length 115 cm, Lot 2056960, Manufacturer St. Jude Medical 14901 DeVeau Place, M