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Class 2 Device Recall Algovita Spinal Cord Stimulation (SCS) System |
![see related information](../images/related-info.gif) |
Date Initiated by Firm |
October 11, 2016 |
Date Posted |
December 17, 2016 |
Recall Status1 |
Terminated 3 on August 08, 2018 |
Recall Number |
Z-0781-2017 |
Recall Event ID |
75459 |
PMA Number |
P130028 |
Product Classification |
Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
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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. |
Code Information |
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. |
Recalling Firm/ Manufacturer |
Nuvectra 10675 Naples St NE Blaine MN 55449-5802
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For Additional Information Contact |
Kathy Jo Fahery 763-951-8219
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Manufacturer 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.
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FDA Determined Cause 2 |
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 in Commerce |
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 |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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PMA Database |
PMAs with Product Code = LGW and Original Applicant = Nuvectra Corporation
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