Megadyne 3035HRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10614559102541), received between Jun 7, 2019 and Oct 4, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fire” (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.

• MalfunctionOct 4, 2019Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN ABDOMINAL PROCEDURE THAT THE DEVICE TURNED ON WHEN BUTTON WAS NOT DEPRESSED. A SIMILAR DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9156353 ↗
• MalfunctionJun 7, 2019Fire; Sparking

  IT WAS REPORTED THAT DURING A TONSILLECTOMY AND ADENOIDECTOMY, WHILE THE PRODUCT WAS IN USE OUTSIDE THE PATIENT THE TIP SPARKED AND FLAMED. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8678772 ↗