MYO/Wire® Ultra-Thin Temporary Pacing Wires VF608ABBRecalls & reported problems
A & E Medical Corporation · MYO/Wire® Ultra-Thin Bipolar V - 60cm - Blue - Flare 8mm electrode · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08718627411872), received between Apr 10, 2019 and Apr 10, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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
Device problems
- Device Difficult to Setup or Prepare1
- Human-Device Interface Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 10, 2019Device Difficult to Setup or Prepare; Human-Device Interface Problem; Device Difficult to Setup or Prepare; Human-Device Interface Problem
COMPLAINT RECEIVED FROM CUSTOMER INDICATES A DIFFICULTY WITH FIXATION AND CONDUCTIVITY WHICH LED TO AN EXTENDED SURGICAL TIME. ANNECDOTALLY CUSTOMER REPORTS OTHER DIFFICULTIES WITH SAME TYPE OF DEVICE. THE COMPLAINT ELUDES TO MULTIPLE OCCASSIONS WITH MORE THAN ONE DEVICE FOR DIFFICULTIES WITH FIXATION, CONDUCTIVITY AND REMOVAL. MDR 2242056-2019-00002 WAS INITIALLY WRITTEN AND SUBMITTED FOR COMPLAINT (B)(4). SUBSEQUENT COMMUNICATION WITH CUSTOMER HAS CONFIRMED THE COMPLAINT WAS ACTUALLY USE ERROR. THE CUSTOMER HAS BEEN COMMUNICATED TO IN CONJUNCTION WITH THE INSTRUCTIONS FOR USE ENFORCING COMPREHENSION OF THE PROPER USE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8501172 ↗
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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