Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Nuvectra Recalled by Nuvectra Due to If used, the optional Swap feature copies programming...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Nuvectra directly.
Affected Products
Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model 4500. For use with Algovita Spinal Cord Stimulation Systems. The version of the software in the Clinician Programmer is v1.1.5. The Algovita Spinal Cord Stimulation system consists of a stimulator (EPG or IPG) that is physically and electrically connected to one or more leads inserted into the patient¿¿"s spinal epidural space. The lead delivers electrical stimulation originating at the stimulator with the purpose of blocking pain signals going to the patient¿¿"s brain. The stimulators are rechargeable, and the frequency of recharging is dependent on individual patient¿¿"s use of the system. The Clinician Programmer (CP) is a hand-held, touch screen device used to create and adjust stimulation parameters that are developed to optimize the therapy for each patient. The CP communicates with the stimulator via the Medical Implant Communication Service (MICS). The CP wirelessly transfers the stimulation parameters to the stimulator. In most clinical settings, the CP can be used by the Health Care Professional to program multiple patient EPGs and IPGs
Quantity: 17 OUS
Why Was This Recalled?
If used, the optional Swap feature copies programming parameters from the external pulse generator (EPG) as well as unintended calibration data to the implantable pulse generator (lPG). This may result in the user being unable to recharge the lPG. This safety notice only applies to CPs Model 4500.
Where Was This Sold?
Germany
About Nuvectra
Nuvectra has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report