Halyard 12480Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651124804), received between May 25, 2018 and May 25, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Smoking” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 25, 2018Smoking; Sparking; Smoking; Sparking

  IT WAS REPORTED THE "NEEDLE NEAR THE SKIN OF THE PATIENT SMOKED AND SPARKED" DURING USE OF THE PAIN GENERATOR. THE CLINICIANS WERE PERFORMING A 3-LEVEL LUMBAR, SINGLE PROBE CASE. AS SOON AS THE SMOKING AND SPARKING STARTED THE CLINICIANS STOPPED THE USE OF THE PAIN GENERATOR. WHEN RESTARTED, IT HAPPENED AGAIN, AND THE IMPEDANCE WAS HIGH. THE DEVICE WAS RESTARTED ONCE MORE AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. THE CLINICIANS PERFORMED A CERVICAL CASE LATER AND HAD NO ISSUE NOR A REPEAT OF THE INCIDENT. THE CLINICIANS NOTICED THE IMPEDANCE WAS HIGH AND REACHED UP TO OHMS (SHUT OFF THE GENERATOR OCCURS AT 1000 OHMS). ADDITIONAL INFORMATION RECEIVED 02-MAY-2018 STATED AFTER REMOVING THE CANNULAS THEY NOTICED ONE OF THE CANNULAS WAS MISSING ABOUT 2MM OF BLACK INSULATION FROM THE ACTIVE TIP. THE PHYSICIAN COMMENTED THAT IT LOOKED CHARRED. NO PATIENT INJURY OBSERVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7545324 ↗