Myo/Wire 025-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841291100324), received between Oct 28, 2016 and May 23, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “No Pacing” (2 reports).

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 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.

• MalfunctionMay 23, 2018No Pacing; No Pacing

  THE CUSTOMER REPORTED SUBSEQUENT TO PLACEMENT IN THE OPERATING ROOM (OR), PACING WIRE STOPPED PACING IN THE CSU POST OPERATIVE UNIT AFTER A COUPLE OF HOURS. IT WAS REPORTED THIS OCCURRED ON THREE SEPARATE PATIENTS IN A SHORT SPAN OF TIME. THE SURGEON INVOLVED HAS UTILIZED THE PRODUCT FOR MANY YEARS. HOSPITAL STAFF WAS UNABLE TO IDENTIFY REASON FOR REPORTED FAILURE. NO FURTHER EVENTS WERE REPORTED. HOSPITAL DID NOT SAVE FAILED UNITS HOWEVER RETURNED PRODUCT FROM THE LOT OF THE REPORTED FAILED WIRES AS WELL AS ONE ADDITIONAL LOT NUMBER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7538900 ↗
• MalfunctionOct 28, 2016No Pacing; No Pacing

  SURGEON STATED THAT WHEN HE CUT THE NEEDLE FROM THE PACING WIRE THE TIP OF THE WIRE WAS LEFT EXPOSED AND WHEN IT TOUCHED TISSUE THE PACING WIRE "SHORTS OUT" AND DID NOT PACE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6063148 ↗

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-2993-2024 · Apr 8, 2024 · Open, Classified
  Medline 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-2991-2024 · Apr 8, 2024 · Open, Classified
  Medline Convenience kits labeled as: CARDIAC PACING PACK, Pack Number DYNJ41223
• Z-2098-2019 · Jun 21, 2019 · Terminated
  A&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 Monopola