Revi™ Wearable Device MA-1004-0500Recalls & reported problems
Bluewind Medical Ltd · The Revi Wearable Device wirelessly powers the Revi Implant and enables control of stimulation parameters. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290017912028), received between Jul 28, 2025 and Jul 28, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Overheating of Device” (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
- Overheating of Device1
Patient problems
- Discomfort1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2025Overheating of Device; Overheating of Device
ECU CHARGER MALFUNCTION - PATIENT SAID 2 DAYS AGO WHEN HER DEVICE WAS ON THE CHARGER, IT GOT SO HOT TO THE POINT SHE COULD NOT TOUCH IT. SHE IS VERY CONCERNED THAT IT WILL KEEP HAPPENING.
Patient problems: Discomfort
MAUDE report 22639873 ↗
Other Implanted Tibial Electrical Urinary Continence Device devices
- Revi™ Implant MA-1007-0600_US_CMBluewind Medical Ltd · Implanted Tibial Electrical Urinary Continence Device16 reports
- Revi™ System Patient Kit KA-9000-0001_US_CMBluewind Medical Ltd · Implanted Tibial Electrical Urinary Continence Device9 reports
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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