FDAApril 6, 2016device
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 ph...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
nuvectra
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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