BioWave Silver Back BioWrap S/M BWRPSILVER-BACK-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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00859911006232), received between Apr 21, 2025 and Mar 24, 2026 — classified as 2 injuries.
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
- Missing Information1
Patient problems
- Blister1
- Superficial (First Degree) Burn1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 24, 2026Missing Information
PATIENT REPORTED DEVELOPMENT OF BLISTERS ON SKIN FOLLOWING USE OF BIOWRAP SILVER BACK, AN ELECTRODE GARMENT WRAP. PRIOR TO USE, PATIENT APPLIED A TOPICAL SPRAY (CIGNA SPRAY ) TO THE SKIN, WHICH WAS RECOMMENDED BY THEIR TREATING CLINICIAN. PATIENT DEVELOPED BLISTERS AT THE SITE OF DEVICE CONTACT.
Patient problems: Blister
MAUDE report 24680018 ↗InjuryApr 21, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
PATIENT REPORTED A BURN USING THE KNEE WRAP. HE HAS BEEN USING IT BEFORE WITH NO ISSUES. HE HAS INCREASED THE INTENSITY TO AS HIGH AS 45-48% ON BOTH KNEES. HE WAS NOT FEELING STIMULATION ON THE RIGHT KNEE ON (B)(6) 2024 SO HE INCREASED THE INTENSITY UP TO 62%. A FEW MINUTES LATER HE FELT A BURN. HE HAS USED IT ON THE LEFT KNEE WITH NO ISSUES. HE USED THE SAME AMOUNT OF CONDUCTIVE CREAM AND CLEANING SKIN WITH WATER AND SOAP ONLY. NO MEDICAL ATTENTION REQUIRED. PATIENT HAS BEEN DIAGNOSED WITH NERVE PAIN AND NO REPORTED SKIN SENSITIVITY.
Patient problems: Superficial (First Degree) Burn
MAUDE report 21873236 ↗
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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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