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Livewire™ 401923Recalls & 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 05414734202602), received between Aug 17, 2020 and Aug 17, 2020 — 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

  • Cardiac Perforation1

Recent adverse event reports

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

  • InjuryAug 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    RELATED MANUFACTURING REF: 3008452825-2020-00399, 3008452825-2020-00404, 3008452825-2020-00405, 3008452825-2020-00406. DURING A PREMATURE VENTRICULAR CONTRACTION (PVC) PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. AFTER 2 HOURS, THE PATIENT BECAME HYPOTENSIVE AND AN ULTRASOUND REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS STABLE WHEN LEAVING THE ROOM. HOWEVER, THE PATIENT WAS THEN TRANSFERRED TO SURGERY FOR REPAIR AND IS IN STABLE CONDITION. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

    Patient problems: Cardiac Perforation

    MAUDE report 10414126 ↗

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.