Biowave Noninvasive Electrodes MK78560 - BWEN01-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00859911006089), received between Apr 9, 2024 and Feb 10, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (4 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PATIENT COMPLETED 30 MINUTE TREATMENT. ONE AND HALF HOUR LATER HE OBSERVED/EXPERIENCED A BURNING SENSATION & REALIZED HE GOT A BURN. HE MENTIONED USING THE NEUROSTIMULATOR AT 40-50% RANGE INTENSITY. ALSO THAT HE WAS USING BRAND NEW ELECTRODES.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 21350018 ↗
• InjuryMay 22, 2024Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  THE PATIENT GOT BURNS ON HIS LEFT HIP; PATIENT SAID HE WAS LYING DOWN ON A SIDE WITH HIS HIP UP IN THE AIR; SKIN WAS CLEAN, AND THE ELECTRODES WERE STICKY. HE SAID HE DIDN'T MOVE DURING THE TREATMENT; THE UNIT WAS PLACED ON THE TABLE. A FEW SECONDS BEFORE THE FULL TREATMENT WAS DONE UNIT FLASHED TRIANGLE. HE HAD STIMULATION AT 50% FOR THE WHOLE TREATMENT.

  Patient problems: Blister

  MAUDE report 19377079 ↗
• InjuryApr 9, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  UNIT/DEVICE IS BURNING PATIENT'S BACK RESULTING IN RAISED WELTS. TREATMENT WITH OUR DEVICE HAS HELPED BUT NOTICED THGE WELTS ONE MONTH BEFORE HE REPORTED THIS COMPLAINT TO MNAUFACTURER. PATIENT TRIED THE TREATMENT WITH NEW SET OF ELECTRODES AND GOT SAME RESULTS. HE DOESNOT FELL ANY BURBNING SENSATION DURIMNG TREATMENT BUT SEES WELTS AFTER THE TREATMENT.

  Patient problems: Rash

  MAUDE report 19074232 ↗
• InjuryApr 9, 2024Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  WIFE HAS BEEN USING HER HUSBAND'S UNIT FOR THE PAST 1 1/2 TO TREAT LEG PAIN FOCUSED IN HER RIGHT HAMSTRING. NEVER HAS HAD ANY ISSUES UNIT YESTERDAY. LATER IN THE DAY AFTER THE TREATMENT, SHE FELT BURNING/ITCHING AND NOTICED A PUS-FILLED BLISTER NEAR THE AREA OR POSSIBLE UNDER THE AREA WHERE ONE OF THE ELECTRODES HAD BEEN PLACED ON HER UPPER HAMSTRING/GLUT AREA. NO ISSUE UNDER THE OTHER PAD WHICH HAD BEEN PLACED 6" APART ON HER LOWER HAMSTRING.

  Patient problems: Blister

  MAUDE report 19070505 ↗
• InjuryApr 9, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PATIENT GOT BURNED BY PADS AND LATER BLISTERS WERE OBSERVED AT PAD SIDE. PATIENT MENTIONED THAT HE CLEANED THE AREA WELL AND USED NEW PADS EACH TIME FOR THE TREATMENT, PADS WERE PLACED AT 1.5 INCHES APART. BLISTERS OCCURED WHEN THE INTENSITIES WERE AT 70% AND 100%, TWICE.

  Patient problems: Blister; Burn(s)

  MAUDE report 19070273 ↗