Recall Z-0781-2017— Nuvectra

Class II FDA medical device recall by Nuvectra, initiated 2016-10-11, terminated 2018-08-08. FDA's recall record names no specific 510(k) clearance for this event. Product: 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 Cord Stimulation System Percutaneous Trial Leads, 12-electrode Lead Kit. Model Number (s) 112x-xx (CT), 108x-xx(T). These are part of the Algovita Spinal Cord Stimulation System. 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.. Reason: 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..

Recalling firm

Nuvectra

Classification

Class II

Status

Terminated

Initiated

2016-10-11

Terminated

2018-08-08

Firm location

Blaine, MN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.