MYO/WIRE™ Disposable Patient Cable 2.0 019-530Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10841291105268), received between Aug 4, 2023 and Jan 6, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2026Failure to Capture

  IT WAS REPORTED THERE WAS LOSS OF CAPTURE ASSOCIATED WITH MOVEMENT OF A PACER WIRE. DUE TO AN UNSTABLE UNDERLYING HEART RHYTHM, A TEMPORARY VENTRICULAR PACEMAKER WAS INSERTED. THE CABLE WAS CHANGED AND PACING SUBSEQUENTLY WORKED WITHOUT DIFFICULTY. THE PATIENT WAS THEN ABLE TO BE MOBILIZE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Arrhythmia

  MAUDE report 23982873 ↗
• MalfunctionJun 24, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED WHILE THE SURGERY WAS BEING PREPARED AT THE OPENING OF THE CASE, IT WAS DISCOVERED THAT THERE WAS DEBRIS WITHIN THE STERILE PACKAGING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE AND THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22319042 ↗
• InjuryAug 4, 2023Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT A PATIENT EXPERIENCED SENSING FAILURE DURING AN URGENT CATH LAB PROCEDURE. AFTER SWAPPING THE PACING WIRES, AND EVENTUALLY SWAPPING THE PATIENT CABLE, SENSING WAS ACHIEVED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Arrhythmia

  MAUDE report 17458064 ↗