Nuvectra Corporation
Country not established
- Devices
- 1
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
Catalogue
Algovita Spinal Cord Stimulation System Ref P130028
PMA PMA
FDA recalls
2016
- 11 Oct 2016 Z-0781-2017 Class II Terminated 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.
- 6 Apr 2016 Z-1600-2016 Class II Terminated 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.
Frequently asked questions
How many devices does Nuvectra Corporation have in the registry?
The registry currently lists 1 device for Nuvectra Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nuvectra Corporation's devices?
Among its 1 most recently registered device, Nuvectra Corporation has devices listed in FDA PMA (1 device).
What risk classes do Nuvectra Corporation's devices fall under?
Among its 1 most recently registered device, the classes recorded for Nuvectra Corporation's devices are Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Nuvectra Corporation?
FDA recall records list 2 recalls initiated by Nuvectra Corporation, the most recent initiated on 2016-10-11. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Nuvectra Corporation in the registry?
The most recently registered devices listed for Nuvectra Corporation include ALGOVITA SPINAL CORD STIMULATION SYSTEM.