FDA Device recall Z-0781-2017
Algovita Spinal Cord Stimulation System, Percutaneous Leads, 8-Electrode Percutaneous Lead Kit
- FDA Device
- Class II
- terminated
- Published 2016-12-28
On 2016-12-28 the FDA classified a Class II recall of Algovita Spinal Cord Stimulation System, Percutaneous Leads, 8-Electrode Percutaneous Lead Kit by Nuvectra, citing 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.….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0781-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-11 |
| Published | 2016-12-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Nuvectra |
| Distribution | US |
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.
Identifiers
| code_info | Lot Numbers: W2886402 , W2888100 , W2904692, W2909622 , W2909623 , W2912562 , W2918496, W2918506 , W2930816, W29…Lot Numbers: W2886402 , W2888100 , W2904692, W2909622 , W2909623 , W2912562 , W2918496, W2918506 , W2930816, W2930816 , W2938384 , W2939156 , W2943651 , W2946424 , W2952157 , W2964008 , W2964009, W2964009 , W2964010, W2964010 , W2964011 , W2972187 , W2978500 , W2981155, W2981155 , W2988382, W2988382 , W3040781 , W3041965, W3041965 , W3043467, W3048908, W3052511 , W3052514, W3052515 , W3057023, W3057024, W3057027, W3057033, W3057033 , W3063066, W3063073, W3063073 , W3088964, W3110760 , W3111249, W3114108, W3119243, W3123219 , W3123220, W3123220 , W3124197, W3127472, W3127472 , W3127473, W3133254, W3133264 , W3135521, W3232789, W3232789 , W3232790, W3232791, W3232792, W3232792 , W3236234, W3236235, W3236237, W3236239, W3236239 , W3321458 , W3321459 , W3321460 , W3321461 , W3321463 , W3321464, W3324818 , W3324820, W3324821 , W3324826 , W3324827, W3324829 , W3324830 , W3335022, W3335022 , W3335027, W3335033 , W3335041 , W3335050, W3335050 , |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0781-2017%22
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