Nuvectra — Class II medical device recall Z-1600-2016
Terminated recall by Nuvectra, reported 2016-05-11. If used, the optional Swap feature copies programming parameters from the external pulse generator (EPG) as we
| Recall number | Z-1600-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nuvectra, Blaine, MN, United States |
| Recall initiated | 2016-04-06 |
| Classified | 2016-05-03 |
| Reported by FDA | 2016-05-11 |
| Terminated | 2017-09-29 |
| Countries outside the US | DE |
| Quantity | 17 ous |
| Lot numbers | P178713, P185700, P187989, P195875, P213108, P257056 |
| Serial numbers | 000010, 000011, 000014, 000015, 000016, FF0043, FF0045, FF0048, FF004B, FF0054, FF005D, FF0064, FF0065, FF0067, FF00A9, FF00AD, FF00BB |
| Model numbers | 4500 |
Product
Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model 4500. For use with Algovita Spinal Cord Stimulation Systems. The version of the software in the Clinician Programmer is v1.1.5. 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. The Clinician Programmer (CP) is a hand-held, touch screen device used to create and adjust stimulation parameters that are developed to optimize the therapy for each patient. The CP communicates with the stimulator via the Medical Implant Communication Service (MICS). The CP wirelessly transfers the stimulation parameters to the stimulator. In most clinical settings, the CP can be used by the Health Care Professional to program multiple patient EPGs and IPGs
Reason for recall
If used, the optional Swap feature copies programming parameters from the external pulse generator (EPG) as well as unintended calibration data to the implantable pulse generator (lPG). This may result in the user being unable to recharge the lPG. This safety notice only applies to CPs Model 4500.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1600-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.