MYO/WIRE™ Disposable Patient Cable 2.0 019-540Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841291105282), received between Aug 10, 2017 and Aug 10, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2017Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  PHONE CALL WAS RECEIVED ON 7/12/2017 FROM DISTRIBUTOR OF DEVICE ((B)(4)) REPORTING COMPLAINT RECEIVED FROM DIRECTOR OF CARDIAC SURGERY AT (B)(6) HOSPITAL (B)(6) PERTAINING TO A PATIENT CABLE (DISPOSABLE MYO LEAD), PART NUMBER 019-540, LOT UNKNOWN. THE COMPLAINT REPORTS THE DEVICE DID NOT FUNCTION ELECTRONICALLY AND WOULD NOT PACE THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6785997 ↗
• MalfunctionAug 10, 2017Device Issue; Connection Problem; Device Issue; Connection Problem

  DISPOSABLE MYO LEAD CABLE CAME UNPLUGGED FROM THE PACING BOX. THE PATIENT CODED IN THE CVICU AND IN THE CVOR. THE CONNECTOR CIRCUMFERENCE OF THE PLUG WAS OBSERVED HAVING A FRACTURE. THE FRACTURE CREATED A "FLIMSY" INTERFACE WITH THE PACING BOX.

  Patient problems: Cardiac Arrest

  MAUDE report 6784843 ↗