Megadyne 0030HRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10614559100479), received between Jan 15, 2020 and May 13, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Human-Device Interface 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 16, 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 13, 2021Self-Activation or Keying; Human-Device Interface Problem; Insufficient Device Problem Information; Self-Activation or Keying; Human-Device Interface Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A PACEMAKER PROCEDURE THAT THE BOVIE WAS LYING ON THE PATIENT¿S CHEST WHILE CHECKING THE PLACEMENT OF THE LEAD WHEN THE OR TECH HEARD A ¿POP¿ SOUND AND SAW SOME SMOKE THEN SAW THAT THE BOVIE HAD BURNT THE PATIENT. THE OR TECH THEN PICKED UP THE BOVIE. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. PATIENT WAS TREATED WITH SOME OINTMENT AND A BANDAGE. BURN WAS VERY SUPERFICIAL. PATIENT IS CURRENTLY DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11820045 ↗
• MalfunctionJan 15, 2020Vibration

  IT WAS REPORTED BY THE SALES REP THAT, DURING AN UNKNOWN PROCEDURE, THE DEVICE KEPT VIBRATING ALTHOUGH THE ACTIVATION SWITCH WAS NOT PRESSED DURING USE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9594114 ↗