Enso M3Recalls & reported problems
Hinge Health, Inc. · Nerve stimulator for pain relief (manufactured in Malaysia) - 2 std., 1 back gel pad · Class 2
- 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 00850045950064), received between Jan 7, 2026 and Apr 1, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Inappropriate/Inadequate Shock/Stimulation1
Patient problems
- Burn(s)1
- Electric Shock1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 1, 2026Inappropriate/Inadequate Shock/Stimulation
I HAVE BEEN USING THE ENSO DEVICE THROUGH HINGE HEALTH FOR ALMOST A YEAR. WHEN I WAS USING IT TODAY, ABOUT 10 MINUTES INTO USE, IT ELECTROCUTED ME.
Patient problems: Electric Shock
MAUDE report 24760721 ↗InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem
USER REPORTED THEY USED THEIR ENSO M3 DEVICE TO ALLEVIATE THEIR LOWER BACK, SCIATICA PAIN. ON (B)(6) 2025, USER USED THEIR DEVICE FOR TWO CONSECUTIVE SESSIONS. USER REPORTED BURN ON (B)(6) 2025 AND THAT THEY DID NOT IMMEDIATELY FEEL THE BURN UNTIL THEY LAID DOWN. USER SOUGHT OUT MEDICAL ATTENTION AND RECEIVED A PRESCRIPTION MEDICATION FOR THEIR BURN. USER ALSO REPORTED THE GEL PADS USED WERE LOSING ADHESION. DEVICE AND GEL PAD WERE REQUESTED TO BE RETURNED TO CONDUCT FURTHER INVESTIGATION. MANUFACTURER NARRATIVE: A PRE-PAID LABEL HAS BEEN SENT TO THE REPORTER TO INITIATE A RETURN OF THE SUSPECTED DEVICE FOR FURTHER INVESTIGATION. SINCE THE DEVICE HAS NOT BEEN RETURNED, A FINAL ROOT CAUSE FOR THE REPORTED INCIDENT HAS NOT YET BEEN DETERMINED. REVIEW OF MANUFACTURING RECORDS AND USER'S SESSION ACTIVITY DOES NOT SHOW INDICATION OF A DEVICE MALFUNCTION. BASED ON AN INITIAL ASSESSMENT OF THE INCIDENT AND CONFIRMED BURNS BY THE USER, THIS REPORT IS BEING FILED. THE ENSO M3 USER MANUAL STATES, "IN RARE CASES, YOU MAY EXPERIENCE SKIN IRRITATION OR BURNS BENEATH A GEL PAD APPLIED TO YOUR SKIN. IF YOU EXPERIENCE AN ADVERSE REACTION, PLEASE STOP USING THE DEVICE AND CONSULT YOUR PHYSICIAN." T
Patient problems: Burn(s)
MAUDE report 23992925 ↗
Other Stimulator, Nerve, Transcutaneous, Over-The-Counter devices
- Aleve 1613538Bayer Healthcare LLC · Stimulator, Nerve, Transcutaneous, Over-The-Counter4 reports
- WiTouch 11.1510Hollywog, LLC · Stimulator, Nerve, Transcutaneous, Over-The-Counter2 reports
- Roscoe Medical DT7202 / DT7202CADrive Devilbiss Healthcare · Stimulator, Nerve, Transcutaneous, Over-The-Counter1 report
- WiTouch Pro 11.1500Hollywog, LLC · Stimulator, Nerve, Transcutaneous, Over-The-Counter1 report
- AUVON AS8012-041Shenzhen Yuwen E-Commerce Co., Ltd. · Stimulator, Nerve, Transcutaneous, Over-The-Counter1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.