Nerivio Infinity FGD000100Recalls & reported problems
Theranica Bio-Electronics Ltd. · Nerivio Infinity is a wireless remote electrical neuromodulation (REN) device for the acute and/or preventive treatment of migraine with or without aura in patients 8 years of age or older. This prescription device is self-applied to the upper arm and should be used in the home environment at the onset of migraine headache or aura. or every other day for preventive treatment. Nerivio Infinity utilizes an endogenous descending analgesic mechanism in which pain in one part of the body inhibits pain in multiple remote body regions (Conditioned Pain Modulation [CPM]). Nerivio Infinity is a wireless wearable battery-operated device controlled by a mobile software application. The battery is rechargeable, and the electronic unit can be used up to 3 years. The Nerivio Infinity Refill is a disposable and replaceable unit. The refill unit is sufficient for up to 18 treatments of 45 minutes each. The application has a graphical user interface (GUI) that includes graphical controls that the user can select using a touch screen. This application activates the stimulation, controls the stimulation intensity, monitors the treatment duration, and pauses and terminates the stimulation. The application also provides notifications and indications on the connection state and the remaining number of treatments. The Nerivio Infinity package under this UDI contains 1 refill unit. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Mar 23, 2026Class IIOpen, Classified
Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
Z-2855-2026 · Root cause: Component design/selection · Recall details · FDA record ↗
Other Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine devices
- Nerivio FGD000075Theranica Bio-Electronics Ltd. · Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine2 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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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