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Livewire™ 401915Recalls & reported problems

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

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734202572), received between Jul 18, 2018 and May 22, 2019 — classified as 2 injuries.

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 Problem2

Patient problems

  • Cardiac Perforation2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    RELATED MANUFACTURER REFERENCE: 3008452825-2019-00239, 3008452825-2019-00243, 2182269-2019-00065, 2182269-2019-00066. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A CARDIAC EFFUSION OCCURRED. DURING ABLATION OF THE CAVOTRICUSPID ISTHMUS (CTI), A POTENTIAL STEAM POP OCCURRED, HOWEVER IT COULD NOT BE CONFIRMED. THE PROCEDURE WAS ABLE TO BE COMPLETED. FOLLOWING THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE. INTRA-CARDIAC ECHOCARDIOGRAPHY(ICE) CONFIRMED AN EFFUSION FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH THE ABBOTT DEVICE.

    Patient problems: Cardiac Perforation

    MAUDE report 8631884 ↗
  • InjuryJul 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    RELATED MANUFACTURING REFERENCE: 9680001-2018-00105, 2182269-2018-00092, 3005334138-2018-00209, 3008452825-2018-00237. DURING A WIDE AREA CIRCUMFERENTIAL ATRIAL FIBRILLATION ABLATION PROCEDURE A CARDIAC PERFORATION OCCURRED. FOLLOWING DUAL TRANSSEPTAL ACCESS AND PULMONARY VEIN ABLATION A PERFORATION WAS DIAGNOSED VIA AN ULTRASOUND CATHETER. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE ABLATION PROCEDURE WAS CONTINUED WITH NO FURTHER ADVERSE PATIENT CONSEQUENCES. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

    Patient problems: Cardiac Perforation

    MAUDE report 7698116 ↗

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.