Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1600-2016 — 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

U.S. FDA — Device Enforcement · United States · 2016-04-06 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1600-2016
Date of alert: 2016-04-06
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Nuvectra
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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