MYO/Wire® Ultra-Thin Temporary Pacing Wires VE60WWRecalls & reported problems
A & E Medical Corporation · MYO/Wire® Ultra-Thin Bipolar V - 60cm - White - Hook 10mm electrode · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08718627411711), received between Oct 23, 2019 and Mar 19, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 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
Device problems
- Fracture2
Patient problems
- Device Embedded In Tissue or Plaque1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 19, 2020Fracture
ON ROUTINE RADIOGRAPH, A TEMPORARY EPICARDIAL PACING WIRE WAS FOUND TO BE FRACTURED. TEMPORARY CARDIAC PACING FOLLOWING CARDIAC SURGERY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9852885 ↗MalfunctionOct 23, 2019Fracture
ON ROUTINE RADIOGRAPH, A TEMPORARY EPICARDIAL PACING WIRE WAS FOUND TO BE FRACTURED. THE EXACT DATE AND TIME OF THE FRACTURE IS NOT KNOWN, BUT THE PACING WIRE WAS IN PLACE FOR ABOUT 2.5 WEEKS WHEN IT WAS FIRST NOTED BY A RADIOLOGIST. THE PATIENT DID NOT REQUIRE AN ADDITIONAL LEAD PLACEMENT OR ANOTHER DEVICE IMPLANT. THE FRACTURED LEAD REMAINS IN THE PATIENT. THE PATIENT WAS NOT HAVING SYMPTOMS: THE FRACTURED PACING WIRE WAS DISCOVERED ON ROUTINE RADIOGRAPH. THERE HAVE BEEN NO OTHER KNOWN CASES LIKE THIS RECENTLY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 9224507 ↗
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 · TerminatedTemporary 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
Other ELECTRODE, PACEMAKER, TEMPORARY devices
- N/A 006173PC. R. Bard, Inc. · ELECTRODE, PACEMAKER, TEMPORARY161 reports
- SWAN-GANZ D200F7Edwards Lifesciences LLC · ELECTRODE, PACEMAKER, TEMPORARY1 recall0 reports
- ETHICON TPW32Ethicon, LLC · ELECTRODE, PACEMAKER, TEMPORARY1 death46 reports
- ETHICON TPW20Ethicon, LLC · ELECTRODE, PACEMAKER, TEMPORARY39 reports
- N/A 520007PC. R. Bard, Inc. · ELECTRODE, PACEMAKER, TEMPORARY33 reports
- Pacel™ 401763St. Jude Medical Cardiovascular Division · ELECTRODE, PACEMAKER, TEMPORARY21 reports
- Pacel™ 401771St. Jude Medical Cardiovascular Division · ELECTRODE, PACEMAKER, TEMPORARY1 death16 reports
- SWAN-GANZ PACING TD CATHETER D205F7Edwards Lifesciences LLC · Electrode, Pacemaker, Temporary13 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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