Nerivio Infinity device recalled for potential battery overheating
Theranica Bioelectronics is recalling Nerivio Infinity devices because the battery may have a thermal runaway event during charging, which could cause smoke and odor. No injuries have been reported. The notice does not describe a fix.
From the FDA notice · Read the official notice ↗
What to do
- Do not charge the device. Contact Theranica Bioelectronics and your care team before using it again.
- Check that the model number is FGD000100, the firmware is 4.1.2.0, and the app version is 7.28.0.11. The serial number format is like NI2544-0300673.
- The notice doesn't say how to get a repair or replacement. Contact Theranica Bioelectronics or the distributor or specialty pharmacy that supplied the device.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
- Sold in
- Nationwide
- Made for
- Adults (18 years to 120 years)
Details
- Units affected
- 11,886 units
- Illnesses reported
- None reported
- Manufactured in
- Poleg Industrial Park, 45, Ha-Melakha, Netanya, Israel
- Classification
- Class II
- Recall number
- Z-2855-2026
In the FDA's words
- Description
- Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11 Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor. Model/Catalog Number: FGD000100. UDI: 01072900175781181125120221NI2544-0300673 Software Version: FW Version 4.1.2.0, App version 7.28.0.11 GTIN: 7290017578118. Serial Number: NI2544-0300673. Distribution: The product's entry point to the US is a 3PL warehouse from which it is being shipped to DME distributors or specialty pharmacy who perform the shipment to the end-user Affected quantity: 11,886 units
- Hazard
- Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.