FDAOctober 11, 2016device
Algovita Spinal Cord Stimulation System, Percutaneous Leads, 8-Electrode Percutaneous Lead Kit; Algovita Spinal Cord Stimulation System Percutaneous Leads, 12-Electrode Percutaneous Lead Kit; Algovita Spinal Cord Stimulation System Percutaneous Trial Leads, 8-electrode Lead Kit; Algovita Spinal C...
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
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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