NexWave 400400Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00852670007007), received between Jan 9, 2026 and Jan 29, 2026 — classified as 4 injuries.

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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT CALLED ZYNEX MEDICAL, INC. TO DISCUSS THE CHAPTER 11 FILING ON (B)(6) 2026, AND WHEN ASKED HOW THE NEXWAVE DEVICE IS WORKING, HE STATED THAT HE HASN'T USED IT SINCE EARLY 2024. THE PATIENT THEN STATED THAT DURING USE OF THE DEVICE, IN 2024, HE HAD AN ADVERSE REACTION TO THE STIMULATION, AND HE FELL BACK AND HIT HIS HEAD. THE PATIENT WENT TO THE HOSPITAL FOR CARE BUT DID NOT STATE THE LEVEL OF CARE RECEIVED. THE PATIENT HAD BEEN USING THE DEVICE A COUPLE WEEKS BUT DOES NOT RECALL HOW HE WAS TREATING HIMSELF AT THE TIME OF THE INCIDENT. THE PATIENT DISPOSED OF THE DEVICE AND DID NOT CALL ZYNEX MEDICAL TO REPORT THE ISSUE AT THE TIME OF THE INCIDENT.

  Patient problems: Fall

  MAUDE report 24211764 ↗
• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS USING IFC THERAPY FOR KNEE PAIN AT 4-5 MA FOR 10 MINUTES. AFTER RECEIVING A "CHECK CONNECTIONS" MESSAGE, THEY CHANGED THE ELECTRODES AND INCREASED THE INTENSITY TO 43 MA BUT INITIALLY FELT NOTHING. AFTER A FEW MINUTES, THEY EXPERIENCED NUMBNESS AND SHARP SENSATIONS IN THE FOOT THAT SPREAD THROUGH THE LEG. THE PATIENT STOPPED THE TREATMENT IMMEDIATELY BUT CONTINUED TO FEEL SHARP SENSATIONS.

  Patient problems: Limb Pain; Numbness

  MAUDE report 24098920 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS AT A CLINIC AND THE ELECTRODES WERE PLACED AROUND HIS KNEE CAP TO SHOW THE PATIENT HOW TO USE THE DEVICE AND WHEN THE DEVICE WAS TURNED TO 3MA ON IFC THE PATIENT LOST CONCIOUSNESS FOR APPROXIMATELY ONE MINUTE. THE CLINIC IMMEDIATELY REMOVED THE DEVICE AND NOTIFIED THE TERRITORY MANAGER.

  Patient problems: Loss of consciousness

  MAUDE report 24085715 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT RECEIVED THERAPY ON THEIR SHOULDER AFTER SURGERY. IT WAS STATED BY THE SURGEON THAT THE PATIENT'S PULSE WAS 20% BELOW NORMAL AND BOTH POTASSIUM AND MAGNESIUM LEVELS WERE LOW PRIOR TO TREATMENT WITH THE DEVICE. THE TREATMENT LEVEL AT THE TIME OF THE INCIDENT WAS AT 4 MA. THE DOCTOR STATED THAT THE DEVICE POSSIBLY CAUSED BRADYCARDIA AND VASOVAGAL DUE TO CAROTID COMPRESSION BECAUSE OF THE PLACEMENT OF THE ELECTRODES.

  Patient problems: Loss of consciousness

  MAUDE report 24021779 ↗