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Livewire™ 401786Recalls & reported problems

St. Jude Medical Cardiovascular Division · Steerable Electrophysiology Catheter · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734202510), received between May 7, 2019 and May 7, 2019 — classified as 1 injury.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Vascular Dissection1

Recent adverse event reports

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

  • InjuryMay 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    DURING A LV LEAD IMPLANT PROCEDURE, DISSECTION OF THE CORONARY SINUS OCCURRED DURING CANNULATION WITH THE CATHETER. NO INTERVENTION WAS REQUIRED AND THE PATIENT IS IN STABLE CONDITION. THE ICD WAS SUCCESSFULLY IMPLANTED WITH RA AND RV LEADS. THE LV LEAD POSITIONING WILL BE ATTEMPTED AGAIN IN APPROXIMATELY 4 WEEKS.

    Patient problems: Vascular Dissection

    MAUDE report 8585829 ↗

Other CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING devices

All CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING devices →

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