Summary: The U.S. FDA and Health Canada are raising awareness about the safe use of Mega 2000 and Mega Soft Patient Return Electrodes by Megadyne Medical Products, Inc. due to reports of burn injuries. Four voluntary recalls have been initiated since June 2023.

Key Takeaways:

  • Burn Injury Reports: Since June 2023, there have been reports of burn injuries, including up to third-degree burns, leading to four voluntary recalls by Megadyne.
  • Usage Instructions: Do not use Mega Soft Pediatric Patient Return Electrodes (product code 0840) on any age group, and only use Mega 2000 and Mega Soft Patient Return Electrodes on patients 12 years and older.
  • Ongoing Monitoring: The FDA is working with Megadyne to ensure updated labeling, safe usage, and continuous monitoring of device performance and burn reports.

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., acquired by Johnson & Johnson in 2017.

Voluntary Recalls and Burn Injury Reports

Since June 2023, Megadyne 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.

Recall Instructions and Safe Use

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.

Intended Use of Patient Return Electrodes

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. 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’s Role and Continued Monitoring

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.

Ongoing Communication

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