Megadyne 004325Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10614559105160), received between Jul 12, 2019 and Jul 12, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Activation” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K072559); 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 18, 2026.

Recalls naming this device

1. Jun 15, 2023Class IIOpen, Classified

   An issue with the Suction Coagulator product family may lead to fluid ingress into the handpiece. Fluid ingress can lead to intermittent device activation, non-activation, or self-activation when plugged into the electrosurgery unit (ESU).

   Z-2257-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• MalfunctionJul 12, 2019Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN THE PEDAL WAS RELEASED ON THE SUCTION COAGULATOR, THE DEVICE WAS STILL SUCTIONING AND THE DEVICE WAS STICKING TO TISSUE. WHEN THE DOCTOR PUSHES THE BUTTON TO ACTIVATE, THE DEVICE DOESN'T IMMEDIATELY START ACTIVATING. WHEN THE DEVICE DOES START ACTIVATING AND THE DOCTOR RELEASED THE ACTIVATION BUTTON, THE DEVICE CONTINUES TO ACTIVATE. THE DOCTOR WOULD CONTINUE TO USE THE SAME DEVICE BUT WOULD BE MINDFUL OF THE ACTIVATION ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8786533 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072559. One submission often covers many models, so check the product and lot details in each record.

• Z-1151-2014 · Feb 27, 2014 · Terminated
  Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek polyester peel pouch, 25 pouches per box. This device i