BioWave Silver Thigh-Calf BioWrap S/M BWRPSILVER-THIGH-CALF-SMRecalls & reported problems
Biowave Corporation · BioWrap Wearable Compression Electrode Garment that utilizes advanced permanent silver fabric electrodes that work exclusively with BioWave High Frequency Neurostimulators. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00859911006546), received between Apr 30, 2025 and Apr 30, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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.
Reports received per month
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
Patient problems
- Superficial (First Degree) Burn1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 30, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
BURN OCCURRED ON MONDAY, 4/14. USER WAS USING THIGH/CALF WRAP ON ARM. CLINICIAN HAD SET USER UP FOR TREATMENT WITH UNIT ON HIS LAP. SHE LEFT AND WHEN SHE CAME BACK TO CHECK ON USER, SHE SAW UNIT WAS ON 100% INTENSITY. USER HAD TURNED INTENSITY ALL THE WAY UP AND TREATMENT IMMEDIATELY ENDED. BURNS WERE NOTICED AFTERWARD.
Patient problems: Superficial (First Degree) Burn
MAUDE report 21938645 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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