Megadyne 004025Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10614559105139), received between Jan 26, 2023 and Feb 29, 2024 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Arcing of Electrodes” (7 reports).

2 other recalls 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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE ENDOSCOPIC SINUS SURGERY, IT WAS OBSERVED THAT INSULATION FROM MAGADYNE DISPOSABLE. CAUTERY LEFT RESIDUAL INSULATION IN THE PATIENT WHEN USED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18809586 ↗
• InjuryFeb 9, 2024Material Separation; Appropriate Device Problem Term/Code Not Available; Material Separation; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT A FRAGMENT OF A MEGADYNE SUCTION COAGULATOR PROBE WAS LEFT IN THE PATIENT. UNKNOWN IF THE FRAGMENT WAS REMOVED OR LEFT IN THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. PATIENT STATUS IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 18675934 ↗
• MalfunctionFeb 5, 2024

  DURING THE ENDOSCOPIC SINUS SURGERY, IT WAS OBSERVED THAT INSULATION FROM MAGADYNE DISPOSABLE CAUTERY LEFT RESIDUAL INSULATION IN THE PATIENT WHEN USED.

  Patient problems: Insufficient Information

  MAUDE report 18650565 ↗
• InjuryJan 26, 2023Arcing of Electrodes; Adverse Event Without Identified Device or Use Problem; Arcing of Electrodes; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TONSILLECTOMY PROCEDURE, THE PATIENT HAD TO RETURN TO THE OR DUE TO RE-BLEEDING. AN ADDITIONAL SURGERY WAS PERFORMED TO STOP THE RE-BLEEDING AND THE PATIENT IS RECOVERING WELL. THE ACCOUNT DOES NOT BELIEVE THERE HAS BEEN ANY ISSUE WITH THE MEGADYNE PRODUCTS IN THE RE-BLEEDS. THE EXACT LOT NUMBER IS UNKNOWN. THE ACCOUNT USES MEGAPOWER GENERATORS, AND ALL GENERATORS WERE PM¿D BY THE BIOMED AND THERE WERE NO ISSUES WITH ANY OF THE GENERATORS. TYPICAL SETTING ON THE GENERATOR ARE COAG 10-15 UP TO 25. THE 004025 REQUIRES AND ADAPTER AND THE ACCOUNT USES VALLEY LAB ADAPTORS. TO DATE THERE IS NO MORE INFORMATION AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16245790 ↗
• InjuryJan 26, 2023Arcing of Electrodes; Adverse Event Without Identified Device or Use Problem; Arcing of Electrodes; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TONSILLECTOMY PROCEDURE, THE PATIENT HAD TO RETURN TO THE OR DUE TO RE-BLEEDING. AN ADDITIONAL SURGERY WAS PERFORMED TO STOP THE RE-BLEEDING AND THE PATIENT IS RECOVERING WELL. THE ACCOUNT DOES NOT BELIEVE THERE HAS BEEN ANY ISSUE WITH THE MEGADYNE PRODUCTS IN THE RE-BLEEDS. THE EXACT LOT NUMBER IS UNKNOWN. THE ACCOUNT USES MEGAPOWER GENERATORS, AND ALL GENERATORS WERE PM¿D BY THE BIOMED AND THERE WERE NO ISSUES WITH ANY OF THE GENERATORS. TYPICAL SETTING ON THE GENERATOR ARE COAG 10-15 UP TO 25. THE 004025 REQUIRES AND ADAPTER AND THE ACCOUNT USES VALLEY LAB ADAPTORS. TO DATE THERE IS NO MORE INFORMATION AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16245781 ↗
• InjuryJan 26, 2023Arcing of Electrodes; Adverse Event Without Identified Device or Use Problem; Arcing of Electrodes; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TONSILLECTOMY PROCEDURE, THE PATIENT HAD TO RETURN TO THE OR DUE TO RE-BLEEDING. AN ADDITIONAL SURGERY WAS PERFORMED TO STOP THE RE-BLEEDING AND THE PATIENT IS RECOVERING WELL. THE ACCOUNT DOES NOT BELIEVE THERE HAS BEEN ANY ISSUE WITH THE MEGADYNE PRODUCTS IN THE RE-BLEEDS. THE EXACT LOT NUMBER IS UNKNOWN. THE ACCOUNT USES MEGAPOWER GENERATORS, AND ALL GENERATORS WERE PM¿D BY THE BIOMED AND THERE WERE NO ISSUES WITH ANY OF THE GENERATORS. TYPICAL SETTING ON THE GENERATOR ARE COAG 10-15 UP TO 25. THE 004025 REQUIRES AND ADAPTER AND THE ACCOUNT USES VALLEY LAB ADAPTORS. TO DATE THERE IS NO MORE INFORMATION AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16245768 ↗
• InjuryJan 26, 2023Arcing of Electrodes; Adverse Event Without Identified Device or Use Problem; Arcing of Electrodes; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TONSILLECTOMY PROCEDURE, THE PATIENT HAD TO RETURN TO THE OR DUE TO RE-BLEEDING. AN ADDITIONAL SURGERY WAS PERFORMED TO STOP THE RE-BLEEDING AND THE PATIENT IS RECOVERING WELL. THE ACCOUNT DOES NOT BELIEVE THERE HAS BEEN ANY ISSUE WITH THE MEGADYNE PRODUCTS IN THE RE-BLEEDS. THE EXACT LOT NUMBER IS UNKNOWN. THE ACCOUNT USES MEGAPOWER GENERATORS, AND ALL GENERATORS WERE PM¿D BY THE BIOMED AND THERE WERE NO ISSUES WITH ANY OF THE GENERATORS. TYPICAL SETTING ON THE GENERATOR ARE COAG 10-15 UP TO 25. THE 004025 REQUIRES AND ADAPTER AND THE ACCOUNT USES VALLEY LAB ADAPTORS. TO DATE THERE IS NO MORE INFORMATION AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16245757 ↗
• InjuryJan 26, 2023Arcing of Electrodes; Adverse Event Without Identified Device or Use Problem; Arcing of Electrodes; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TONSILLECTOMY PROCEDURE, THE PATIENT HAD TO RETURN TO THE OR DUE TO RE-BLEEDING. AN ADDITIONAL SURGERY WAS PERFORMED TO STOP THE RE-BLEEDING AND THE PATIENT IS RECOVERING WELL. THE ACCOUNT DOES NOT BELIEVE THERE HAS BEEN ANY ISSUE WITH THE MEGADYNE PRODUCTS IN THE RE-BLEEDS. THE EXACT LOT NUMBER IS UNKNOWN. THE ACCOUNT USES MEGAPOWER GENERATORS, AND ALL GENERATORS WERE PM¿D BY THE BIOMED AND THERE WERE NO ISSUES WITH ANY OF THE GENERATORS. TYPICAL SETTING ON THE GENERATOR ARE COAG 10-15 UP TO 25. THE 004025 REQUIRES AND ADAPTER AND THE ACCOUNT USES VALLEY LAB ADAPTORS. TO DATE THERE IS NO MORE INFORMATION AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16245703 ↗
• InjuryJan 26, 2023Arcing of Electrodes; Adverse Event Without Identified Device or Use Problem; Arcing of Electrodes; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TONSILLECTOMY PROCEDURE, THE PATIENT HAD TO RETURN TO THE OR DUE TO RE-BLEEDING. AN ADDITIONAL SURGERY WAS PERFORMED TO STOP THE RE-BLEEDING AND THE PATIENT IS RECOVERING WELL. THE ACCOUNT DOES NOT BELIEVE THERE HAS BEEN ANY ISSUE WITH THE MEGADYNE PRODUCTS IN THE RE-BLEEDS. THE EXACT LOT NUMBER IS UNKNOWN. THE ACCOUNT USES MEGAPOWER GENERATORS, AND ALL GENERATORS WERE PM¿D BY THE BIOMED AND THERE WERE NO ISSUES WITH ANY OF THE GENERATORS. TYPICAL SETTING ON THE GENERATOR ARE COAG 10-15 UP TO 25. THE 004025 REQUIRES AND ADAPTER AND THE ACCOUNT USES VALLEY LAB ADAPTORS. TO DATE THERE IS NO MORE INFORMATION AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16245684 ↗
• InjuryJan 26, 2023Arcing of Electrodes; Adverse Event Without Identified Device or Use Problem; Arcing of Electrodes; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TONSILLECTOMY PROCEDURE, THE PATIENT HAD TO RETURN TO THE OR DUE TO RE-BLEEDING. AN ADDITIONAL SURGERY WAS PERFORMED TO STOP THE RE-BLEEDING AND THE PATIENT IS RECOVERING WELL. THE ACCOUNT DOES NOT BELIEVE THERE HAS BEEN ANY ISSUE WITH THE MEGADYNE PRODUCTS IN THE RE-BLEEDS. THE EXACT LOT NUMBER IS UNKNOWN. THE ACCOUNT USES MEGAPOWER GENERATORS, AND ALL GENERATORS WERE PM¿D BY THE BIOMED AND THERE WERE NO ISSUES WITH ANY OF THE GENERATORS. TYPICAL SETTING ON THE GENERATOR ARE COAG 10-15 UP TO 25. THE 004025 REQUIRES AND ADAPTER AND THE ACCOUNT USES VALLEY LAB ADAPTORS. TO DATE THERE IS NO MORE INFORMATION AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16245658 ↗

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-2257-2023 · Jun 15, 2023 · Open, Classified
  MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch
• 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