Mega 2000 0825Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10614559100943), received between Jun 2, 2022 and Jun 2, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K982826); they may or may not involve this specific model.

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

• InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A BREAST IMPLANTATION THAT THE POTENTIAL 0825 COULD BE RELATED TO A BURN.

  Patient problems: Burn(s); Deformity/ Disfigurement; Pain

  MAUDE report 14575629 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K982826. One submission often covers many models, so check the product and lot details in each record.

• Z-1994-2023 · Jun 1, 2023 · Open, Classified
  MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery