BiowaveHOME BWHD01Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00859911006072), received between Apr 9, 2024 and Jun 23, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Circuit Failure” (1 report).

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

• InjuryJun 23, 2026Insufficient Device Problem Information

  A VETERAN PATIENT WAS USING THE BIOWAVEHOME FOR TREATMENT AT THE BILATERAL LATERAL CERVICAL MUSCLES (C6/C7) AT HER USUAL INTENSITY OF 12-16%. THE PATIENT WAS LYING DOWN AND NOT MOVING DURING TREATMENT. SKIN PREPARATION WAS PERFORMED USING A BABY WIPE PRIOR TO ELECTRODE PLACEMENT. UPON TURNING THE DEVICE ON, THE DISPLAY SHOWED AN ABNORMAL READOUT OF "7 MINUTES." THE DEVICE THEN DELIVERED AN UNINTENDED ELECTRICAL OUTPUT OF SUFFICIENT MAGNITUDE TO PHYSICALLY DISPLACE THE PATIENT FROM A LYING POSITION. THE PATIENT'S HUSBAND WAS PRESENT AND WAS REQUIRED TO PHYSICALLY DISCONNECT THE LEAD WIRE FROM THE UNIT TO TERMINATE THERAPY, AS THE POWER BUTTON WAS NON-FUNCTIONAL. FOLLOWING THE EVENT, THE DEVICE DISPLAY SHOWED A BLUE SCREEN AND THE UNIT COULD NOT BE POWERED OFF VIA THE POWER BUTTON. THE PATIENT REPORTED BEING VERY SORE THE FOLLOWING DAY. NO MEDICAL ATTENTION WAS SOUGHT. NO VISIBLE INJURY OR SKIN MARKS WERE OBSERVED.

  Patient problems: Myalgia

  MAUDE report 25600033 ↗
• MalfunctionApr 30, 2025Output above Specifications; Output above Specifications

  THE VETS SON CALLED AND INFORMED SHE KEEPS GETTING SHOCKED BY UNIT. SHE GETS SHOCKED WHEN TURNING ON THE UNIT. SHE JUST STARTED USING UNIT (B)(6) 2025. NOW IT KEEPS SHOCKING HER UNTIL SHE INCREASES THE INTENSITY THEN IT STOPS. NO INJURY. SHE IS CLEANING SKIN WITH ONLY WATER SO FAR. SHE HAS GOT PAIN RELIEF BUT CONCERNED ABOUT THE SHOCKING FEELING.

  Patient problems: Electric Shock

  MAUDE report 21938639 ↗
• MalfunctionOct 11, 2024Circuit Failure; Circuit Failure

  UNIT WAS USED IN SALES DEMO. FROM SALES REP: I PLACED THE ELECTRODES ON HIS WRIST AREA, AND WHEN IT WAS TURNED ON AT 0.0% HE SAID HE FELT A JOLT. WE THEN TRIED THEM AT THE BASE OF HIS NECK AND WHEN IT WAS RAISED TO ABOUT 11%, HE FELT A STRONG SHOCK AND IMMEDIATELY WANTED TO TAKE THEM OFF. I TOOK THE UNIT HOME AND DID SOME TROUBLESHOOTING - TRIED DIFFERENT ELECTRODES ON THE SAME MACHINE, TRIED THE SAME ELECTRODES ON A DIFFERENT MACHINE, ETC. - THE PROBLEM IS DEFINITELY THE MACHINE. I HAD THE ELECTRODES AT THE BASE OF MY NECK, AND WHEN I TURNED ON THE MACHINE AT 0.0% I FELT A SLIGHT JOLT, JUST AS THE VOLUNTEER HAD. I THEN TURNED IT UP TO AROUND 30%, AND THEN FELT A SUDDEN SHOCK THAT WENT ALL THE WAY FROM MY NECK DOWN TO MY FINGERTIPS, SO I THINK THAT'S WHAT HE HAD EXPERIENCED AS WELL.

  Patient problems: Electric Shock

  MAUDE report 20429393 ↗
• InjuryApr 9, 2024Use of Incorrect Control/Treatment Settings; Inadequate or Insufficient Training; Use of Incorrect Control/Treatment Settings; Inadequate or Insufficient Training

  WHEN PATIENT TURNS ON THE DEVICE , UNIT IS BLINKING AND BEEPING AND SHOCKING AT THE SAME TIME PT WANTED TO PRESS MINUS BUTTON OR POWER BUTTON NONE OF THEM WORKED SO PT JUST PEELED ELECTRODES FROM ARM. INJURY OCCURRED BUT PATIENT DID NOT SEEK ANY MEDICAL ATTENTION. PT DOESN'T HAVE ANY BLISTERS, BUT PT COULDN'T MOVE ARM FOR 3 HOURS. IN THE FOLLOW UP THE P[ATIENT MENTIONED THAT RIGH ARM ISNT FUNCTIONING PROPERLY, NO DAMAGE TO THE SKIN BUT CANT LIFT HER ARM OVER HEAD OR BEHIND THE BACK.

  Patient problems: Hypoesthesia

  MAUDE report 19075352 ↗