Medtronic Neuromodulation recalls Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargea…

Recall date

September 18, 2024

Source

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

Recall number

Z-0372-2025

FDA classification

Class II

Brand / firm

Medtronic Neuromodulation

Sold / distributed

Worldwide - US Nationwide distribution in the states of AL, AZ, CA, FL, GA, ID, MD, MI, MN, MO, NC, NJ, OH, PA, SC, TX, VA, and WA. The countries of Austria, Belgium, Denmark, Finland, Germany, Ireland, Italy, Japan, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and United Kingdom.

Why it was recalled

The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use.

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

What was recalled

Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used with Neurostimulator Inceptiv INS Model 977119 and Percept RC INS Model B35300 as part of the Deep Brain Stimulation (DBS) system. WR9220A is used with InterStim Micro, Model 97810, as part of Pelvic Health system