MACROLYTE 400-2100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30653405006996), received between Jun 25, 2020 and Jul 3, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  A CUSTOMER REPORTED THAT THE 400-2100, MACROLYTE DISPERSIVE ELECTRODE DEVICE WAS USED IN A RIGHT L5-S1 HEMILAMINOTOMY DISCECTOMY PROCEDURE ON (B)(6) 2025, AND "PATIENT REPORTED A BURN TO HER RIGHT POSTERIOR THIGH (WHERE BOVIE PAD WAS PACED). PATIENT COMPLAINT OF PAIN, ITCHING, BUMPY AND BLISTERED SKIN. THE PATIENT IS BEING SEEN BY A BURN SPECIALIST FOR TREATMENT. CONMED SYSTEM 2450 PASSED ALL SAFETY CHECKS.¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE. FURTHER ASSESSMENT FOUND THE BURN "WAS DEEMED A CHEMICAL BURN/ALLERGIC REACTION FROM THE ADHESIVE BY A WOUND SPECIALIST." NO MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION WAS REPORTED. THE PATIENT'S CURRENT STATUS IS "HEALTHY, CONCERNED OVER SCAR." THE 60-2450-120, SYSTEM 2450 120 VAC 50/60 HZ ELECTROSURIGCAL UNIT WILL BE LISTED AS A CONCOMITANT DEVICE. THERE ARE NO ALLEGATIONS FILED AGAINST IT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF A POSSIBLE CHEMICAL BURN OF UNKNOWN DEGREE.

  Patient problems: Caustic/Chemical Burns

  MAUDE report 22393981 ↗
• InjurySep 2, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON BEHALF OF THEIR CUSTOMER, THE DISTRIBUTOR IN (B)(6) REPORTED ISSUES WITH THE 400-2100, GROUND PAD TDS ADULT, LOT 202102024, THAT CLINICA NUESTRA CARTAGENA RECENTLY EXPERIENCED ON (B)(6) 2021. THE ONLY INFORMATION RECEIVED WAS THAT PATIENT WHO, AT THE BEGINNING OF THE PROCEDURE, PLACES AN ELECTROPLATE ON THE SKIN ON THE RIGHT THIGH WHILE WORKING, IMMEDIATELY THERE IS SLIGHT BURNS PRODUCED BY IT. WE PROCEED TO REMOVE PLAQUE AND CURE THE PATIENT. IT IS NOTED THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING OTHER EQUIPMENT AND INVOLVED A (B)(6) YEAR OLD. PICTURES PROVIDED BY THE DISTRIBUTOR SHOW THERE IS A BLACKENED SUBSTANCE ON THE PAD AND THERE IS HAIR ATTACHED TO THE PAD AS WELL. IT IS NOT CLEAR IF THE IMAGES SHOW A 2ND OR 3RD DEGREE BURN TO THE PATIENTS THIGH AREA AND / OR IF THE SKIN WAS ALSO PULLED OFF WHEN THE PAD WAS REMOVED. CLARIFICATION WAS RECEIVED THAT NOTES THE PATIENT WAS DISINFECTED AND DRESSED, THE SURGICAL SITE WAS INCISED, AND WHEN THE SURGEON ACTIVATED THE ELECTRODE, THEY HEARD A NOISE AND SMELL AS WHEN SOMETHING WAS BURNING AND IMMEDIATELY CHECKED THE SITE OF THE PAD AND DETECTED THE BURN. WHEN THE AREA WAS CHECKED, THE HAIR WAS DETACHED WITH PART OF THE SKI

  Patient problems: Burn(s); Skin Tears

  MAUDE report 12413491 ↗
• InjuryJun 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT DURING A LEEP (LOOP ELECTROSURGICAL EXCISION PROCEDURE) ON APPROXIMATELY (B)(6) 2020 THE PATIENT RECEIVED A POSSIBLE 3RD DEGREE BURN. THE BURN WAS NOTICED AFTER THE PROCEDURE, IT WAS LOCATED UNDER THE 400-2100, MACROLYTE GROUNDING PAD. THE PROCEDURE WAS APPROXIMATELY 37 MINUTES LONG. THERE WERE NO ALARMS INDICATING THERE WAS ANY ISSUE. THE PAD WAS ATTACHED TO A BIRTCHER 4400 - POWER PLUS. THE SKIN WAS NOT PREPPED PRIOR TO PAD PLACEMENT, (NO CLIPPING OF HAIR OR CLEANED WITH SOLUTIONS). THE SKIN WAS INTACT PRIOR TO PAD PLACEMENT. THE PAD HAD FULL CONTACT WITH THE SKIN. THE PAD WAS PLACED ON THE RIGHT ANTERIOR MID THIGH. THE BURN WAS TREATED WITH OINTMENT AND PATIENT IS REPORTED AS OK. THIS REPORT IS BEING RAISED AS PATIENT INJURY DUE TO RECEIVING A 3RD DEGREE BURN.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 10194319 ↗