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Algovita Spinal Cord Stimulation System, Percutaneous Leads, 8-Electrode Percutaneous Lead Kit; ...

FDA Device Recall #Z-0781-2017 — Class II — October 11, 2016

Recall Summary

Recall Number Z-0781-2017
Classification Class II — Moderate risk
Date Initiated October 11, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Nuvectra
Location Blaine, MN
Product Type Devices
Quantity 406 OUS, 985 US

Product Description

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.

Distribution Pattern

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

Lot / 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.

Other Recalls from Nuvectra

Recall # Classification Product Date
Z-1600-2016 Class II Nuvectra, Algovita Spinal Cord Stimulation Syst... Apr 6, 2016

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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