{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-27", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "150431", "product_res_number": "Z-0781-2017", "event_date_initiated": "2016-10-11", "event_date_posted": "2016-12-17", "recall_status": "Terminated", "event_date_terminated": "2018-08-08", "res_event_number": "75459", "product_code": "LGW", "pma_numbers": [ "P130028" ], "product_description": "Algovita Spinal Cord Stimulation System, Percutaneous Leads, 8-Electrode Percutaneous Lead Kit; \nAlgovita Spinal Cord Stimulation System Percutaneous Leads, 12-Electrode Percutaneous Lead Kit; \nAlgovita Spinal Cord Stimulation System Percutaneous Trial Leads, 8-electrode Lead Kit;\nAlgovita Spinal Cord Stimulation System Percutaneous Trial Leads, 12-electrode Lead Kit. \nModel Number (s) 112x-xx (CT), 108x-xx(T). \nThese are part of the Algovita Spinal Cord Stimulation System.\n\nThe 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\nindividual patient s use of the system.", "code_info": "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.", "firm_fei_number": "3010309840", "recalling_firm": "Nuvectra", "address_1": "10675 Naples St NE", "city": "Blaine", "state": "MN", "postal_code": "55449-5802", "additional_info_contact": "Kathy Jo Fahery\n763-951-8219", "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.\nIt has been reported that in some percutaneous leads, the stylet protruded beyond the distal lead tip.", "root_cause_description": "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.", "product_quantity": "406 OUS, 985 US", "distribution_pattern": "US: Nationwide (CA, TX, KY, FL, IL,PA,OH, GA, NJ, NC, KS, AR, CO, NE, NY, VA, AZ, OK).\n\nOUS: Germany", "openfda": { "pma_number": [ "P190002", "P010032", "P130022", "P030017", "P800040", "P130028", "P840001", "P210037" ], "registration_number": [ "3005210579", "3010326622", "3004519921", "3003120897", "2133641", "9616693", "2649622", "3018094310", "3003335547", "3006630150", "3004209178", "3007616088", "3013368220", "3016618265", "3015173212", "3027063190", "1627487", "2648729", "3010972758", "3008514029", "3010052483", "3014507028", "3015200795", "1928237", "2124215", "2032521", "3007882731", "3021836309", "2024311", "3020969413", "3003477135", "9681477", "2135338", "2182291", "3010086866", "3012693387", "2183744", "3038429246", "2133810", "3006705815", "3019807891", "9610139", "3013973539", "3015924373", "3008988055", "2134604", "2182207", "2133772", "3010966701", "1035166", "3004593495", "2030624", "3013023969", "3009380063", "3010531069", "3005160949" ], "fei_number": [ "3005210579", "3010326622", "3003120897", "3005700659", "2649622", "3018094310", "3003335547", "3006630150", "3002806500", "3000206435", "3005846326", "3013368220", "3007616088", "3016618265", "3015173212", "3027063190", "3000209794", "2648729", "3010972758", "1627487", "3008514029", "3010052483", "3014507028", "3015200795", "3002618605", "3003574398", "1928237", "2124215", "3000203466", "3004369318", "3007882731", "3021836309", "2024311", "3020969413", "3003477135", "2182291", "3010086866", "3012693387", "2183744", "3038429246", "3006705815", "3019807891", "3002623849", "3013973539", "3015924373", "3008988055", "3000203066", "2182207", "3010966701", "1035166", "3004593495", "3013023969", "3002807439", "3009380063", "3010531069", "3005160949" ], "device_name": "Stimulator, Spinal-Cord, Totally Implanted For Pain Relief", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ] }