Nuvectra: Medical Device Recall in 2016 - (Recall #: Z-1600-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 6, 2016

Date Posted: May 11, 2016

Recall Number: Z-1600-2016

Event ID: 73884

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.

Status: Terminated

Product Quantity: 17 OUS

Code Information:

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

Distribution Pattern:

Germany

Voluntary or Mandated:

Voluntary: Firm initiated