Halyard VAHT026-17_0003Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10809160378809), received between Apr 7, 2023 and Apr 7, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult or Delayed Activation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 2023Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED BY PHYSICIAN: AT THE BEGINNING OF THE CASE AFTER MAKING THE SKIN INCISION FOR STERNOTOMY, WE NOTICED THE BOVIE WAS NOT FUNCTIONING PROPERLY - IT WAS NOT CONDUCTING WHEN ACTIVATED. WE SWITCHED THE PEN TO A DIFFERENT GENERATOR AND IT SEEMED TO WORK FOR A PERIOD OF TIME, BUT AT ONE POINT WHILE I WAS CAUTERIZING A SMALL VESSEL HELD BETWEEN MY FORCEPS, THE BOVIE CONDUCTED THROUGH MY GLOVE AND SHOCKED ME. I FOUND THIS VERY ODD AND AFTER CHANGING MY GLOVE I NOTICED A 1-2CM SUPERFICIAL LINEAR BURN ON THE PATIENTS SKIN. IT WAS IN THE STERILE FIELD BUT FAR LATERAL TO WHERE WE WERE OPERATING. IT WAS NEAR WHERE THE BOVIE CABLE WAS SECURED TO THE DRAPE. I DID NOT SEE AN OBVIOUS DEFECT IN THE CABLE BUT IT WAS AT THIS POINT WE CHANGED BOVIE PEN AND GENERATOR AGAIN AND PROCEEDED WITH THE CASE WITHOUT FURTHER INCIDENT. AT THE END OF THE CASE, THE SMALL SUPERFICIAL BURN WAS EXCISED AS AN ELLIPSE AND CLOSED PRIMARILY IN LAYERS TO MINIMIZE SCARRING. THE END RESULT IS A 2CM LINEAR INCISION ON HIS LEFT ANTERIOR CHEST WALL. AVID MEDICAL IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY (REF (B)(4) OPEN HEART PACK) THAT INCLUDES THE FOLLOWING COMPONENT: CAUTERY, BUTTON HOLD EZ CLEAN, VENDOR R

  Patient problems: Burn(s)

  MAUDE report 16700898 ↗