FDA Device recall Z-1600-2016
Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model 4500
- FDA Device
- Class II
- terminated
- Published 2016-05-11
On 2016-05-11 the FDA classified a Class II recall of Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model 4500 by Nuvectra, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1600-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-06 |
| Published | 2016-05-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Nuvectra |
| Distribution | n/a |
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
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.
Identifiers
| code_info | Serial 000010 000011 FF0043 FF0045 000014 000015 000016 FF0054 FF0048 FF004B FF005D FF0064 FF0065 FF0067…Serial 000010 000011 FF0043 FF0045 000014 000015 000016 FF0054 FF0048 FF004B FF005D FF0064 FF0065 FF0067 FF00A9 FF00AD FF00BB Lot P178713 P185700 P187989 P195875 P213108 P257056 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1600-2016%22
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