MYO/Wire® Ultra-Thin Temporary Pacing Wires QEF2008ABW2DRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08718627411032), received between Jul 7, 2025 and Jul 7, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Defibrillation/Stimulation Problem” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K033858); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2025Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THE PATIENT HAD A PACING WIRE PLACED AND PACED CORRECTLY STRAIGHT AFTER IMPLANTATION. SUBSEQUENTLY, AFTER THE PROCEDURE WHILE THE PATIENT WAS IN CICU, THE ATRIAL PACING WIRE WAS NOT CONDUCTING THE LEVELS OF ELECTRICAL CURRENT REQUIRED; HOWEVER, THE VENTRICULAR WIRE WAS WORKING CORRECTLY. FURTHER, THE WIRE COMPLETELY FAILED WHEN REQUIRED IN THE INTENSIVE CARE UNIT. THEREFORE, THE PATIENT HAD TO HAVE A PERMANENT PACEMAKER IMPLANTED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 22412557 ↗
• InjuryJul 7, 2025Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THE PATIENT HAD A PACING WIRE PLACED AND PACED CORRECTLY STRAIGHT AFTER IMPLANTATION. SUBSEQUENTLY, AFTER THE PROCEDURE WHILE THE PATIENT WAS IN CICU, THE ATRIAL PACING WIRE WAS NOT CONDUCTING THE LEVELS OF ELECTRICAL CURRENT REQUIRED; HOWEVER, THE VENTRICULAR WIRE WAS WORKING CORRECTLY. FURTHER, THE WIRE COMPLETELY FAILED WHEN REQUIRED IN THE INTENSIVE CARE UNIT. THEREFORE, THE PATIENT HAD TO HAVE A PERMANENT PACEMAKER IMPLANTED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 22412554 ↗
• InjuryJul 7, 2025Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THE PATIENT HAD A PACING WIRE PLACED AND PACED CORRECTLY STRAIGHT AFTER IMPLANTATION. SUBSEQUENTLY, AFTER THE PROCEDURE WHILE THE PATIENT WAS IN CICU, THE ATRIAL PACING WIRE WAS NOT CONDUCTING THE LEVELS OF ELECTRICAL CURRENT REQUIRED; HOWEVER, THE VENTRICULAR WIRE WAS WORKING CORRECTLY. FURTHER, THE WIRE COMPLETELY FAILED WHEN REQUIRED IN THE INTENSIVE CARE UNIT. THEREFORE, THE PATIENT HAD TO HAVE A PERMANENT PACEMAKER IMPLANTED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 22412552 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033858. One submission often covers many models, so check the product and lot details in each record.

• Z-1038-2012 · Apr 18, 2011 · Terminated
  Temporary Pacing Wire, BIPOLAR, Models BM, V, VE and VF, Rx Only, STERILE/EO, Single use only -- Mce (MEDICAL CONCEPTS EUROPE) --- Manufacturer ECM B.V. Oost-Om 54, P.O. Box 53, NL