MYO/Wire® Ultra-Thin Temporary Pacing Wires V605PBBRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08718627411537), received between Sep 17, 2020 and Sep 17, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2020Fracture; Difficult to Remove

  TEMPORARY EPICARDIAL PACER WIRES WERE PLACED DURING CARDIAC SURGERY ON THE DAY OF THE SURGERY. AFTER THREE DAYS FROM THE SURGERY, RADIOLOGY REPORT NOTED A FRACTURED PACER WIRE OVERLYING THE UPPER ABDOMEN. IT IS UNKNOWN HOW PACER WIRE FRACTURED. THE RISK OF REMOVAL WAS DETERMINED TO BE GREATER THAN IF IT REMAINED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10546365 ↗

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