Livewire™ 401582Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734202251), received between Nov 12, 2019 and Nov 3, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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

Recent adverse event reports

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

• MalfunctionNov 3, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DURING THE PROCEDURE, AN UNKNOWN SOFT, FLOPPY STRUCTURE WAS NOTED AT THE TIP OF THE CATHETER UPON REMOVAL FROM THE PATIENT. THE CATHETER WAS INTRODUCED TO THE RIGHT ATRIUM VIA THE GROIN AND WOULD NOT ADVANCE TO THE CORONARY SINUS. UPON REMOVAL, A SOFT, FLOPPY STRUCTURE WAS OBSERVED AT THE TIP OF THE CATHETER. THE CATHETER WAS REPLACED TO CONTINUE THE PROCEDURE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10777785 ↗
• InjuryNov 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

  Patient problems: Cardiac Perforation

  MAUDE report 9310761 ↗