Myo/Wire 025-201Recalls & reported problems
A & E Medical Corporation · Temp Pacing Wire · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841291100362), received between Jan 14, 2021 and Jan 14, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult or Delayed Separation” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K803086); 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 16, 2026.
Most reported problems
Device problems
- Difficult or Delayed Separation1
Patient problems
- Needle Stick/Puncture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 14, 2021Difficult or Delayed Separation; Difficult or Delayed Separation
DISTRIBUTOR REPORTED THAT A SURGEON AT (B)(6) HOSPITAL HAS HAD DIFFICULTY BREAKING THE KEITH NEEDLE OF THE PACING WIRE AT THE SCORE MARK FOR THE PAST 2 MONTHS. IN ONE INSTANCE, HE"TORE HIS THUMB."
Patient problems: Needle Stick/Puncture
MAUDE report 11171576 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K803086. One submission often covers many models, so check the product and lot details in each record.
- Z-2991-2024 · Apr 8, 2024 · Open, ClassifiedMedline Convenience kits labeled as: CARDIAC PACING PACK, Pack Number DYNJ41223
- Z-2993-2024 · Apr 8, 2024 · Open, ClassifiedMedline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036O; 2) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036OH; 3) CATH ACCESSORY PACK, Pack
- Z-2098-2019 · Jun 21, 2019 · TerminatedA&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)- Temporary Pacing Electrode as follows: 021-001 MYO/Wire Ultra-Flex Monopolar
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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