Mega Soft 0845Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 10614559103906), received between Jan 14, 2019 and Jul 27, 2026 — classified as 42 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Arcing of Electrodes” (13 reports).

2 FDA recall records name this device's identifier, 2 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 8, 2023Open, Classified

   Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.

   Z-0597-2024 · Root cause: Under Investigation by firm · FDA record ↗

2. Jun 1, 2023Open, Classified

   Firm has received reports of patient burns in surgical procedures where device was used.

   Z-1998-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 72 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during a C-Section there was an occurrence of a patient burn during a surgical procedure due to insulation and the presence of the pad under the patient.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 50038395 ↗
• MalfunctionNov 5, 2025Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS SPARKING WITH THE MEGADYNE PAD WHILE IN USE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23475621 ↗
• MalfunctionNov 5, 2025Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS SPARKING WITH THE MEGADYNE PAD WHILE IN USE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23475604 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A NEPHRECTOMY THERE WAS A PATIENT BURN.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 22860466 ↗
• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DOCTOR USED MEGA SOFT UNIVERSAL ELECTRODE AND AFTER THE SURGERY THE DOCTOR OBSERVED THE SKIN GOT SEVERED BURNED IN POSTERIOR SIDE OF PATIENT BODY.

  Patient problems: Burn(s); Full thickness (Third Degree) Burn

  MAUDE report 22742602 ↗
• MalfunctionAug 5, 2025Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS SPARKING WITH THEIR MEGADYNE PAD WHILE IN USE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22719521 ↗
• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS A PAD SITE BURN.

  Patient problems: Blister; Burn(s)

  MAUDE report 21374674 ↗
• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE THE PATIENT SUFFERED A BURN ON THEIR LOWER LEG POSTERIOR. WHILE THE REP WAS DISCUSSING THE IFU CHANGE AT THE ACCOUNT THE ACCOUNT MENTIONED THIS ISSUE HAPPENED MONTHS AGO.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 20684412 ↗
• MalfunctionNov 11, 2024Arcing of Electrodes; Human-Device Interface Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Arcing of Electrodes; Human-Device Interface Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE FROM A VETERINARY THAT DURING AN OPERATION WITH THE MEGADYNE MAT, THE MAT EXPLODED AND CAUGHT FIRE. SMALL FLASHES ALL OVER THE MAT, WHICH THEN ENDED IN SEVERAL FLAMES. AFTER THE INCIDENT, YOU COULDN'T SEE WHAT HAD HAPPENED ON THE MAT. THE PATIENT WAS A SMALL YORKSHIRE TERRIER (APPROX. 3 KG). HE SUFFERED BURNS TO HIS STOMACH. THE MAT WAS CONNECTED TO AN MEGADYNE GENERATOR EXPIRATION DATE 30.09.2023.

  Patient problems: Burn(s); Full thickness (Third Degree) Burn; Necrosis; Partial thickness (Second Degree) Burn; Scar Tissue

  MAUDE report 20651317 ↗
• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A RIGHT SUPRASPINATUS REPAIR SURGERY, MEGASOFT WAS PLACED FOR THE PATIENT. THE PATIENT GOT BURNS ON THE BACK.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 19643105 ↗
• InjuryJun 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CABG PROCEDURE THE PATIENT SUFFERED PLATE SITE BURN WHILE USING DEMO UNIT OF MEGASOFT. PLATE SITE SACRAL BURN.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 19546660 ↗
• MalfunctionApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE FOR A CANINE THAT ONCE FINISHED WITH AN ANIMAL PROCEDURE IT WAS NOTICED THE PATIENT EXPERIENCED A BURN ON THEIR SIDE. TREATMENT OF THE BURN WAS NOT PROVIDED TO THE SALES REP.

  Patient problems: Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn

  MAUDE report 19069894 ↗
• MalfunctionApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SPINE PROCEDURE THAT A PATIENT/CANINE HAD EXPERIENCED A PAD SIDE BURN. SURGEON STATED THAT THERE WAS A FOLLOW UP DONE TO TREAT THE BURN.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 19069803 ↗
• MalfunctionFeb 1, 2024Human-Device Interface Problem; Appropriate Device Problem Term/Code Not Available; Human-Device Interface Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A ARTHROSCOPY A PATIENT PRESENTED BURNS. THE PATIENT WAS SUBMITTED TO ARTHROSCOPY/ACL PROCEDURE LASTING 2:50 IN DORSAL DECUBITUS. AT THE END OF THE PROCEDURE WAS OBSERVED BURN IN THE COCCYX REGION EVIDENCED BY RED REGION CHARACTERISTIC OF FIRST DEGREE BURN. IN THE TRANSOPERATORY WAS USED MERGADYNE CAUTERY PLATE AND THERMAL MATTRESS WITH WATER HEATING WITH TEMPERATURE OF 38ºC THE THERMAL MATTRESS WAS OVERLAID THE MEGADYNE CAUTERY PLATE. THIS PROCEDURE HAS EXTRAVASATION OF SERUM AT THE TIME OF DEGERMATION AND INTRAOPERATIVE.

  Patient problems: Burn(s)

  MAUDE report 18621416 ↗
• MalfunctionJan 31, 2024Human-Device Interface Problem; Appropriate Device Problem Term/Code Not Available; Human-Device Interface Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A C-SECTION THE SURGEON HAD THE CAUTERY IN HER LEFT HAND AND WAS HOLDING A SNAP IN HER RIGHT HAND. THE SNAP WAS ATTACHED TO THE PATIENT AND HER RIGHT HAND WAS RESTING/IN CONTACT WITH THE ABDOMEN, WHERE THE BURN OCCURRED. THE SURGEON PRESSED THE CAUTERY BUTTON TO CAUTERIZE AND FELT A BURNING SENSATION IN HER RIGHT HAND. THE SURGEON UP WITH A RED MARK ON HER RIGHT HAND. WE¿VE REMOVED THE MEGADYNE PAD FROM THE OR FOR NOW UNTIL WE SORT OUT THE ISSUE. WE¿VE BEEN USING THE PADS SEVERAL TIMES EACH DAY SINCE THEY¿VE ARRIVED AND THIS IS THE FIRST INCIDENT WE¿VE HAD. THERE WAS NO LARGE POOLING OF FLUID OR ANYTHING ABNORMAL ABOUT THIS CASE OR SET UP.

  Patient problems: Burn(s)

  MAUDE report 18619216 ↗
• MalfunctionJan 31, 2024Human-Device Interface Problem; Appropriate Device Problem Term/Code Not Available; Human-Device Interface Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT PRESENTED BURNS. PATIENT WAS SUBMITTED TO LEIFOT OSTEOTOMY PROCEDURE. AT THE END OF THE SURGERY WE NOTICED A BURN IN THE BUTTOCKS AND COCCYX. THE PROCEDURE LASTED 06 HOURS IN THE DORSAL POSITION WITH THE USE OF DISPERSIVE MEGADYNE ELECTRODE (CAUTERY PLATE) AND THERMAL MATTRESS IN CONTINUOUS USE OF HEATING AT 38°. THIS THERMAL MATTRESS PUT ON THE CAUTERY PLATE. BLADDER PROBE PASSAGE WAS ALSO PERFORMED THAT MAY HAVE WET THE PATIENT. I EMPHASIZE THAT THIS MATTRESS IS OFTEN USED IN OTHER SURGERIES AND THAT BEFORE THE ACQUISITION OF THE MEGADYNE PLATE WE HAD NO BURN INCIDENT. AFTER USING THIS MEGADYNE PLATE WE HAVE ALREADY HAD 03 BURN INCIDENT. TOPICAL MEDICATION WAS USED.

  Patient problems: Burn(s)

  MAUDE report 18617294 ↗
• MalfunctionJan 31, 2024Human-Device Interface Problem; Appropriate Device Problem Term/Code Not Available; Human-Device Interface Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A CABG PROCEDURE IT WAS SUSPECTED OF PAD SITE BURN WITH MEGASOFT 0845. ON EXAMINATION MEGASOFT PAD WAS FUNCTIONING NORMALLY AND AS PER THE DETAILS PROVIDE THE BURN SEEMS TO BE LIKELY OF LIQUID BURN

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 18617122 ↗
• InjuryJan 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE A PATIENT EXPERIENCED A SIDE PAD BURN. NO ADDITIONAL INFORMATION WAS GIVEN AT THE TIME.

  Patient problems: Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn; Superficial (First Degree) Burn

  MAUDE report 18580656 ↗
• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A C-SECTION THERE WAS AN INCIDENT IN THE OR WHERE A PATIENT ENDED UP WITH A CAUTERY BURN ON HER ABDOMEN. OUR NEW MEGADYNE CAUTERY PADS WERE IN USE DURING THIS INCIDENT. DURING THE CASE THE SURGEON HAD THE CAUTERY IN HER LEFT HAND AND WAS HOLDING A SNAP IN HER RIGHT HAND. THE SNAP WAS ATTACHED TO THE PATIENT AND HER RIGHT HAND WAS RESTING/IN CONTACT WITH THE ABDOMEN, WHERE THE BURN OCCURRED. THE SURGEON PRESSED THE CAUTERY BUTTON TO CAUTERIZE AND FELT A BURNING SENSATION IN HER RIGHT HAND. WHEN SHE MOVED HER HAND THE SURGEON SAW A WOUND ON THE PATIENTS ABDOMEN, WHICH WAS NOT THERE PRIOR TO THE INCIDENT. THE SURGEON ALSO ENDED UP WITH A RED MARK ON HER RIGHT HAND WHICH WAS DIRECTLY ABOVE WHERE THE PATIENT HAD A BURN. WE DISCLOSED TO THE PATIENT THAT SHE WAS BURNED FROM THE CAUTERY AND REQUESTED CONSENT TO TAKE A PHOTO OF HER BURN, TO WHICH SHE AGREED. WE¿VE REMOVED BOTH MEGADYNE PADS FROM THE OR FOR NOW UNTIL WE SORT OUT THE ISSUE. WE¿VE BEEN USING THE PADS SEVERAL TIMES EACH DAY SINCE THEY¿VE ARRIVED AND THIS IS THE FIRST INCIDENT WE¿VE HAD. THERE WAS NO LARGE POOLING OF FLUID OR ANYTHING ABNORMAL ABOUT THIS CASE OR SET UP.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 18444934 ↗
• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A BILATERAL BREAST REDUCTION, THERE WAS A MEGASOFT PAD USED. THERE WAS A STAPLE ON THE DRAPE ON THE PATIENTS RIGHT HIP. AFTER THE PROCEDURE A BURN WAS NOTICED ON THE PATIENT RIGHT HIP. THE BURN IS THE SAME SIZE AS SKIN STAPLE. THE TISSUE COLOR IS BLACKISH BROWN. AT THE TIME OF THE CALL IT WAS UNKNOWN HOW THE PATIENT WAS TREATED FOR THE BURN.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 18334075 ↗
• MalfunctionDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN K-9 PROCEDURE THAT THE POSITIONER WAS PLACED BETWEEN THE PATIENT AND THE MEGASOFT PAD THAT RESULTED IN SIGNIFICANT BURNS. CAUSE OF THE BURNS WERE THE RESULT OF THE POSITIONER BEING PLACED BETWEEN THE PATIENT AND THE MEGASOFT PAD, THE METAL RIVETS OF THE POSITIONER WERE IN DIRECT CONTACT WITH THE PATIENTS.

  Patient problems: Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn

  MAUDE report 18246542 ↗
• MalfunctionDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN K-9 PROCEDURE THAT THE POSITIONER WAS PLACED BETWEEN THE PATIENT AND THE MEGASOFT PAD THAT RESULTED IN SIGNIFICANT BURNS. CAUSE OF THE BURNS WERE THE RESULT OF THE POSITIONER BEING PLACED BETWEEN THE PATIENT AND THE MEGASOFT PAD, THE METAL RIVETS OF THE POSITIONER WERE IN DIRECT CONTACT WITH THE PATIENTS.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 18246340 ↗
• InjuryOct 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE PATIENT PRESENTED BURNS. I EMPHASIZE THAT THIS MATTRESS IS OFTEN USED IN OTHER SURGERIES AND THAT BEFORE THE ACQUISITION OF THE MEGADYNE PLATE WE HAD NO BURN INCIDENT. AFTER USING THIS MEGADYNE PLATE WE HAVE A BURN INCIDENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 17985130 ↗
• InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ABDOMINOPLASTY A PATIENT HAS SUFFERED SOME BURNS ON THE BACK AFTER A 5 HOUR SURGERY.

  Patient problems: Partial thickness (Second Degree) Burn; Scar Tissue

  MAUDE report 17950628 ↗
• MalfunctionAug 24, 2023Human-Device Interface Problem; Appropriate Device Problem Term/Code Not Available; Unintended Electrical Shock; Human-Device Interface Problem; Appropriate Device Problem Term/Code Not Available; Unintended Electrical Shock

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CUSTOMER STATES A PATIENT "RECEIVED A SHOCK" ON A MEGASOFT UNIVERSAL PAD. TRANSFERRED TO BIOMED FOR PAD TESTING QUESTION. CUSTOMER ALSO STATED THAT PATIENT RECEIVED SLIGHT BURN ON THE RIGHT LEG. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Burn(s)

  MAUDE report 17616261 ↗