July 31, 2024

The U.S. Food and Drug Administration (FDA), together with Health Canada, is raising awareness among health care providers and facilities about the safe use of Mega 2000 and Mega Soft Patient Return Electrodes by Megadyne Medical Products, Inc. (“Megadyne”). 

Since June 2023, Megadyne has initiated four voluntary recalls including various product codes of Mega 2000 and Mega Soft Patient Return Electrodes due to reports of burn injuries in pediatric and adult patients and health care providers. The reports of burns include up to third-degree burns requiring intervention, which may lead to prolonged hospital stay, scarring, and additional surgeries. Burn injuries may lead to long-lasting impacts on patients, especially under the age of 12 years.

Following the instructions in the manufacturer’s recall notifications can help ensure the safe use of these products. In summary:

• Do not use Mega Soft Pediatric Patient Return Electrodes (product code 0840) in any age group; 
• Only use Mega 2000 and Mega Soft Patient Return Electrodes (product codes: 0800, 0830, 0835, 0845, 0846, 0847, and 0848) on patients 12 years and older.

FDA Recommendations

The unique device identifier (UDI) information for affected products is provided below.

• Do not use Mega Soft Pediatric Patient Return Electrodes (product 0840) in any age group. 
• Only use Mega 2000 and Mega Soft Patient Return Electrodes (product codes: 0800, 0830, 0835, 0845, 0846, 0847, and 0848) on patients 12 years and older, even though these devices currently have labeling of “>0.35 kg (>0.8 lb)” or “>25 lb (>11.3 kg)” on the pads. Do not use them on neonates, infants, and children under the age of 12 years old.
  • Review the information for Megadyne’s June 2023, December 2023, and June 2024 recalls (corrections to the Instructions for Use (IFU) to change the intended use population to patients 12 years and older, and to provide proper cleaning, placement, and setup steps). 
  • Be aware that though the following devices currently have printing of “>0.35 kg (>0.8 lb)” on the pads, they should only be used for patients 12 years and older. 
    • Mega Soft Universal Patient Return Electrode (product 0845)
    • Mega Soft Universal Dual Patient Return Electrode (product 0846)
    • Mega Soft Universal Plus Patient Return Electrode (product 0847)
    • Mega Soft Universal Plus Dual Patient Return Electrode (product 0848)
  • Be aware that though the following devices currently have printing of “>25 lb (>11.3 kg)” on the pads, they should only be used for patients 12 years and older. 
    • Mega 2000 Patient Return Electrode (product 0800) 
    • Mega Soft Reusable Patient Return Electrode (product 0830) 
    • Mega Soft Dual Reusable Patient Return Electrode (product 0835) 
  • Follow the Instructions for Use (IFU) for Mega 2000 and Mega Soft Patient Return Electrodes for proper cleaning, placement, and setup steps for the pads.
  • Follow patients post-operatively in the usual manner after procedures involving the use of Mega 2000 and Mega Soft pads.
• Contact Megadyne if you have any questions about the Mega Soft Pediatric, Mega 2000 or Mega Soft Patient Return Electrode recalls or if you did not receive the manufacturer’s customer letters, at the Ethicon Resource Department: 1-877-ETHICON (1-877-384-4266), Monday through Friday, 8:00 AM to 5:00 PM ET. 
• Report problems with Mega 2000 and Mega Soft Patient Return Electrodes to the FDA.

Background

Patient return electrodes are used during monopolar electrosurgery. The patient return electrode conducts monopolar electrosurgical energy from target tissue of a patient back to one or two electrosurgical units or generators. Electrosurgical use is restricted to use with isolated monopolar electrosurgical generators. These devices are not intended for radiofrequency ablation. Mega Soft are intended to be used as 24-month reusable patient return electrodes. Mega 2000 are intended to be used as 18-month reusable patient return electrodes.

FDA Actions

The FDA is working with Megadyne to help ensure that health care providers and facilities are aware of the recall instructions, to update the labeling for affected products (including the printing on the pads that will continue to be manufactured), and to continue to monitor device performance and reports of burns.

The FDA will continue to keep health care providers and the public informed if new or additional recommendations become available.

Unique Device Identifier (UDI)

The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use. For more information on UDI, please visit Unique Device Identification System (UDI Systems).

The table below includes the UDI information provided by Megadyne for Mega Soft Pediatric Patient Return Electrodes, which have been recalled (removed) and should not be used in any age group:     

 Figure 1: Example showing a Mega Soft Pediatric Patient Return Electrode

The table below includes the UDI information provided by Megadyne for Mega 2000 and Mega Soft Patient Return Electrodes which have been recalled (corrected) and should only be used in patients 12 years and older:      

*Although the devices currently have permanent labeling of “>25 lb (>11.3 kg)” on the pads, they should only be used for patients 12 years and older.

^Megadyne has stopped manufacturing and distributing these devices; however, existing supplies of these devices that have not yet expired can still be used until their indicated expiry dates.

**Although the devices currently have permanent labeling of “>0.35 kg (>0.8 lb)” on the pads, they should only be used for patients 12 years and older.

§Megadyne continues to distribute these devices with the outdated pad labeling and paper IFU, while actively working on updated labeling. 

 Figure 2: Example showing a Mega 2000 Patient Return Electrode

Figure 3: Example showing a Mega Soft Patient Return Electrode

Reporting Problems to the FDA

The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with patient return electrode devices. 

By promptly reporting adverse events, you can help the FDA identify and better understand the risks associated with medical devices.

Contact Information

If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE) at FDA.