Nuvectra: 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.

Recall number

Z-0781-2017

Recalling firm

Nuvectra

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.

Status

Terminated

Initiated

2016-10-11

Posted

2016-12-17

Terminated

2018-08-08

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.

Root cause

Nonconforming Material/Component

Action

Nuvectra field sales associate or contracted distributor were sent a Nuvectra Urgent Field Safety Notice (Field Action Number: 2016-03) on 10/11/2016 via Fed-Ex. The letter provided background information, described the problem, & the product involved in the recall. The letter listed the potential clinical implications, rate of occurrence, recommendations and mitigations and action needed. Provided consignees with notices for them to deliver to physicians as well as Response forms for them and the physician. For questions contact Kathy Jo Fahery +01.763.951.8219.

Quantity

406 OUS, 985 US

Distribution

US: Nationwide (CA, TX, KY, FL, IL,PA,OH, GA, NJ, NC, KS, AR, CO, NE, NY, VA, AZ, OK). OUS: Germany

Lot, serial or model codes

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 , W3335055, W3335055 , W3343777, W3343777 , W3348715 , W3356371, W3356371 , W3357155, W3357155 , W3357157 , W3357159, W3357159 , W3357160 , W3357162, W3357164 , W3357167, W3357169 , W3362186 , W3362187, W3362187 , W3362188, W3362188 , W3362209 , W3374818 , W3374820, W3374821 , W3374823 , W3378359, W3378360, W3389104, W3389105 , W3389112, W3389117 , W3393665 , W3393666 , W3393667, W3393668 , W3396586 , W3396603, W3396608, W3396609 , W3399272 , W3424531, W3424531 , W3424542, W3424565 , W3424585, W3424586, W3424586 , W3424589, W3424591 , W3424593, W3424599, W3424602, W3424616 , W3424623 , W3424627 , W3442616 , W3442617, W3442617 , W3442618, W3442618 , W3442619 , W3448170, W3448171, W3448172 , W3448173 , W3448174 , W3454201 , W3454202 , W3462791 , W3462792 , W3462794, W3462795, W3462795 , W3462796, W3462797, W3462798, W3472638, W3472639, W3472639 , W3472640 , W3472641, W3472641 , W3475288, W3475289, W3475289 , W3475290, W3475290 , W3475291, W3475291 , W3493137, W3498560, W3498562, W3498564, W3504760, W3504762, W3504763, W3504766 , W3506847, W3506848, W3506851, W3536038 , W3536039, W3536039 , W3539484, W3540924.

510(k) numbers

not on file

PMA numbers

["P130028"]

Product code

LGW

Firm FEI

3010309840

Firm city

Blaine

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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