Nuvectra Recalls
2 recalls on record · May 11, 2016 to December 28, 2016 · Medical Devices
December 28, 2016Medical DevicesFDA
Nuvectra recalls Algovita Spinal Cord Stimulation System, Percutaneous Leads, 8-Electrode Percutaneous Lead Kit; Algovita Spinal Cord
Hazard: Nuvectra is conducting a recall due to two clinical risks that are associated with certain percutaneous leads currently being used in the Algovita Spinal Cord Stimulation System. It has been reported that in some percutaneous leads, the stylet protruded beyond the distal lead tip.
May 11, 2016Medical DevicesFDA
Nuvectra recalls Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model 4500. For use with Algovita Spinal Cord Sti
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.