MYO/Wire® Ultra-Thin Temporary Pacing Wires BMZF605ACBBGRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08718627412527), received between Nov 18, 2022 and Jul 24, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Frayed” (1 report).

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

• InjuryJul 24, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT A CARDIAC PATIENT HAD TEMPORARY PACING WIRES PLACED IN THE OPERATING ROOM POST-OPERATIVELY. LATER AT NIGHT IT WAS DISCOVERED THAT THE PACING WIRE HAD FRAYED AND PIERCED THROUGH THE HEART WALL. THE PATIENT IS CURRENTLY IN STABLE CONDITION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Cardiac Perforation

  MAUDE report 19819774 ↗
• InjuryNov 18, 2022Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PACING WIRE THAT ATTACHES TO THE PATIENT'S HEART MALFUNCTIONED, RESULTING IN 3 EPISODES OF VENTRICULAR FIBRILLATION AFTER R ON T PHENOMENON. PATIENT REQUIRED CPR. PACING CABLE WAS SET AS A BACKUP RATE OF 50 WHILE THE PATIENT HAD HIS OWN RHYTHM OF 90. DESPITE THIS, THE PACER PACED THE PATIENT INAPPROPRIATELY AND CAUSED V-FIB. MILIAMPS WERE SET TO 10MA MILIVOLTS SET TO 2. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Ventricular Fibrillation

  MAUDE report 15824664 ↗

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