Algovita Spinal Cord Stimulation System — Class II medical device recall Z-0781-2017
Terminated recall by Nuvectra, reported 2016-12-28, distributed nationwide. Nuvectra is conducting a recall due to two clinical risks that are associated with certain percutaneous leads
| Recall number | Z-0781-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nuvectra, Blaine, MN, United States |
| Recall initiated | 2016-10-11 |
| Classified | 2016-12-17 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2018-08-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE |
| Lot numbers | W2886402, W2888100, W2904692, W2909622, W2909623, W2912562, W2918496, W2918506, W2930816, W2938384, W2939156, W2943651, W2946424, W2952157, W2964008, W2964009, W2964010, W2964011, W2972187, W2978500, W2981155, W2988382, W3040781, W3041965, W3043467, W3048908, W3052511, W3052514, W3052515, W3057023, W3057024, W3057027, W3057033, W3063066, W3063073, W3088964, W3110760, W3111249, W3114108, W3119243 and 123 more |
| Model numbers | 112X-XX |
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 for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.