Edited By : Emily Miller
This page features 4 Cited Research Articles
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Latest MegaDyne Electrode Lawsuit Updates

MegaDyne electrode lawsuits are still in the early stages, and there have been no settlements or jury verdicts as of September 2024.

Timeline of MegaDyne Electrode Lawsuits

  • August 2024:
    Lawyers began investigating claims on behalf of people burned by MegaDyne Patient Return Electrodes.
  • May 2024:
    MegaDyne recalled Mega Soft Pediatric Patient Return Electrodes devices, and the company announced it would discontinue the 0840 pediatric pad product.
  • December 2023:
    MegaDyne sent an Urgent Medical Device Correction letter specifically for the Mega Soft Electrodes to warn customers not to use the product in children under the age of 12 because of burn reports.
  • June 2023:
    Customers of MegaDyne began receiving Urgent Medical Device Correction letters informing them of reports of serious burns associated with Mega 2000 and Mega Soft Reusable Patient Return Electrodes.

Injuries included in these lawsuits are second and/or third-degree burns after undergoing electrosurgery with a MegaDyne Mega 2000 or Mega Soft Patient Return Electrode.

Can I File a MegaDyne Electrode Lawsuit?

You may qualify to file a MegaDyne electrode lawsuit if you or your child were burned after surgery using a MegaDyne Mega 2000 and/or Mega Soft Reusable Patient Return Electrode.

The main qualifying injuries for these lawsuits are second- or third-degree burns. These may require additional surgery, hospitalization and medical treatment.

The patient must have had electrosurgery using the MegaDyne product between March 11, 2021 and July 31, 2024.

It’s important to note that these are just guidelines, and only a licensed attorney can tell you if you qualify. Make sure you contact a lawyer right away because there are time limits to file your claim.

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What MegaDyne Electrode Devices Are Included in Lawsuits?

MegaDyne electrode devices included in lawsuits are various recalled models of the Mega 2000 and Mega Soft Reusable Patient Return Electrodes. Reusable patient electrodes help control electric currents as they pass through a patient’s body during electrosurgery for adults and children.

MegaDyne devices in lawsuits are:
  • Mega 2000 Patient Return Electrode 0800
  • Mega Soft Reusable Patient Return Electrode 0830
  • Mega Soft Dual Reusable Patient Return Electrode 0835
  • Mega Soft Pediatric Patient Return Electrode 0840
  • Mega Soft Universal Patient Return Electrode 0845
  • Mega Soft Universal Dual Patient Return Electrode 0846
  • Mega Soft Universal Plus Patient Return Electrode 0847
  • Mega Soft Universal Plus Dual Patient Return Electrode 0848

The MegaDyne electrode pad is placed on the operating table, and the patient lies down on top of the pad. The pad then conducts the electric current from the patient’s tissue back to the electrosurgical unit to prevent any overheating during surgery.

Were the MegaDyne Electrodes Recalled?

There have been four recalls associated with these devices from July 2023 to May 2024. In total, over 21,000 Mega 2000 and Mega Soft devices were recalled. As of July 31, 2024, the company has reported 63 injuries and zero deaths related to the recalled MegaDyne electrode devices, according to the FDA.

MegaDyne recalled these devices after it received reports of patient burns. Some of these were serious second- and third-degree burns. These burns can be especially devastating to children.

Because of these serious injuries, the FDA classified this recall as its most serious Class I recall.

MegaDyne devices in recalls are:
  • Mega 2000 Patient Return Electrode 0800
  • Mega Soft Reusable Patient Return Electrode 0830
  • Mega Soft Dual Reusable Patient Return Electrode 0835
  • Mega Soft Pediatric Patient Return Electrode 0840
  • Mega Soft Universal Patient Return Electrode 0845
  • Mega Soft Universal Dual Patient Return Electrode 0846
  • Mega Soft Universal Plus Patient Return Electrode 0847
  • Mega Soft Universal Plus Dual Patient Return Electrode 0848

In addition to a recall, MegaDyne announced it would discontinue all Ethicon MegaDyne Mega Soft Pediatric Patient Return Electrodes on May 10, 2024.

“The combination of these conditions may be more likely when the pad is used with infants and small children. Because the pediatric pad is designed for patients between 0.8 to 50 pounds, which would be predominantly patients under the age of 12, the decision was made to discontinue and recall the 0840 pediatric pad product,” MegaDyne said in its recall notice.

The recalled devices were distributed between March 11, 2023 and May 9, 2023.

Please seek the advice of a qualified professional before making decisions about your health or finances.
Last Modified: September 4, 2024

4 Cited Research Articles

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  1. FDA. (2024, July 31). Megadyne Recalls MEGA 2000 and MEGA Soft Reusable Patient Return Electrodes for Risk of Serious Burn Injuries to Patients. Retrieved from https://www.fda.gov/medical-devices/medical-device-recalls/megadyne-recalls-mega-2000-and-mega-soft-reusable-patient-return-electrodes-risk-serious-burn
  2. FDA. (2024, May 10). MEGADYNE Initiates Global Discontinuation and Voluntary Recall of MEGA SOFT Pediatric Patient Return Electrode. Retrieved from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/megadynetm-initiates-global-discontinuation-and-voluntary-recall-mega-softtm-pediatric-patient
  3. FDA. (2024, July 31). Electrode Pad Recall: Megadyne Removes MEGADYNE MEGA SOFT Pediatric Patient Return Electrodes for Risk of Serious Burn Injuries to Patients. Retrieved from https://www.fda.gov/medical-devices/medical-device-recalls/electrode-pad-recall-megadyne-removes-megadyne-mega-soft-pediatric-patient-return-electrodes-risk
  4. Whooley, S. (2023, July 11). J&J’s Ethicon has a serious Megadyne electrode recall due to potential burns in electrosurgery. Retrieved from https://www.massdevice.com/ethicon-megadyne-serious-electrode-recall-electrosurgery/