QB1 NMES System QB-1000-216Recalls & reported problems
Motive Health, Inc. · QB1 NMES System; S/M, Left · 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 00854691008254), received between Oct 21, 2020 and Oct 21, 2020 — 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.
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
- Use of Device Problem1
Patient problems
- Burning Sensation1
- 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.
InjuryOct 21, 2020Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method
ON (B)(6) 2020, (B)(6) CONTACTED CYMEDICA ORTHOPEDICS AND REPORTED THE FOLLOWING. "WE HAD TO CANCEL A PATIENT'S SURGERY TODAY DUE TO WOUNDS ON HIS UPPER LEG WHICH HE BELIEVES WERE FROM THE E-VIVE MACHINE. HE BEGAN USING THE MACHINE 2 WEEKS AGO AND HAD BEEN USING IT EVERYDAY, TWICE PER DAY FOR 20 MINUTES AT A TIME. HE DEVELOPED THE WOUNDS 3 DAYS AGO BUT COULDN'T RECALL IF IT WAS FROM THE STRAP OR A POSSIBLE BURN?"
Patient problems: Burning Sensation; Superficial (First Degree) Burn
MAUDE report 10713187 ↗
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- Evolve System AG608081AInmode M.D Ltd · Stimulator, Muscle, Powered2 reports
- emField 5038Zimmer MedizinSysteme GmbH · Stimulator, Muscle, Powered1 report
- QB1 NMES System QB-1000-207Motive Health, Inc. · Stimulator, Muscle, Powered1 report
- Motive Knee System OT01-1002Motive Health, Inc. · Stimulator, Muscle, Powered1 report
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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