Medtronic Neuromodulation recalls Model 37751 Recharger Product Usage: The Medtronic 37751 Recharger is a hand-held device used to charge the battery in…

Recall date

October 3, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0700-2017

FDA classification

Class II

Brand / firm

Medtronic Neuromodulation

Sold / distributed

Worldwide Distribution - US Nationwide including DC OUS: Canada and others.

Why it was recalled

Medtronic has identified an increased number of complaints from customers involving reports of Rechargers (Medtronic Model 37751 Recharger, which is included in Models 37754 and 97754 Charging Systems,Spinal Cord Stimulation)that are in an unresponsive error state, where the Recharger is non-functional with a blank display screen and is beeping every 5 seconds. Medtronic has determined all Rechargers manufactured starting in November 2014 (indicated by serial numbers beginning with NKA4 or NKU4) are more susceptible to this error state.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Model 37751 Recharger Product Usage: The Medtronic 37751 Recharger is a hand-held device used to charge the battery in a patient s neurostimulator. It includes a display to provide information on the charging system. The charging system consists of the Model 37751 Recharger, an AC power supply and power cord (Model 37761) and an antenna.