Megadyne 004225Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10614559105153), received between Dec 12, 2024 and Dec 12, 2024 — classified as 1 injury.

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

• InjuryDec 12, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: DIRECT TUMORAL PUNCTURE EMBOLIZATION OF ONYX BEFORE ENDOSCOPIC ENDONASAL RESECTION OF A MASSIVE JUVENILE ANGIOFIBROMA FOR A PATIENT WITH VON WILLEBRAND DISEASE ¿ A CASE REPORT AND REVIEW OF LITERATURE AUTHOR(S): LAURA-ELISABETH GOSSELIN, PIERRE-OLIVIER CHAMPAGNE, PASCALE LAVOIE, SYLVIE NADEAU. CITATION: INTERNATIONAL JOURNAL OF SURGERY CASE REPORTS 120 (2024) 109784. THE AIM OF THIS STUDY IS TO DEMONSTRATE THE SAFETY AND THE USEFULNESS OF THIS EMBOLIZATION TECHNIQUE ON A PEDIATRIC CASE OF JUVENILE ANGIOFIBROMA AND TO COMPARE OUR RESULTS TO PREVIOUSLY REPORTED CASES. THIS IS A CASE OF A 12-YEAR-OLD PATIENT SUFFERING FROM VON WILLEBRAND DISEASE PRESENTED WITH VOLUMINOUS JUVENILE ANGIOFIBROMA WITH INTRACRANIAL EXTENSION. INTERNAL CAROTID ARTERY BRANCHES PARTIALLY VASCULARIZED THE TUMOR. THE PATIENT UNDERWENT SURGICAL INTERVENTION WITH ENDONASAL ENDOSCOPIC APPROACH. SURGICAL RESECTION OF THE ANTERIOR TUMORAL SECTION AND A PARTIAL DEBULKING OF THE RIGHT ORBIT WAS ACHIEVED WITH MEGADYNE¿ SUCCION COAGULATORS (ETHICON©). HOWEVER, AFTER A PARTIAL RESECTION OF THE NASOPHARYNX PORTION, AN IMPORTANT TUMORAL BLEEDING COMPELLED SURGEONS TO STOP THE SURG

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20912695 ↗

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