Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeab

FDA device recall Z-0372-2025 · posted 2024-11-13 · Open, Classified

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

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

Action taken

The recalling firm issued letters dated September 2024 on 9/18/2024 via UPS 2-Day Air. The letter explained the issue, product scope, and the customer actions. The actions included: (1) Identify and quarantine all unused affected WR Kits. Attachment A of the letter provides guidance on identifying potentially affected devices; (2) Return all unused affected WR Kits using the instructions in the enclosed customer confirmation form and contact Medtronic Customer Service to obtain a replacement WR Kit; (3) Direct patients who cannot establish a recharge session using their WR to promptly contact Medtronic Customer Service to obtain a replacement WR Kit; (4) Complete the enclosed Customer Confirmation Form; (5) Share this notice with all those who need to be aware of this issue within or outside your organization or to any organization where the potentially affected product has been transferred or distributed and maintain a copy of this notice in your records. Medtronic initiated communication of the potential issue via physical mailing to one (1) customer beginning on 08-July-2025 in the U.S.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LGW

Quantity affected

118 wireless rechargers

Distribution

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, Irelan

Date initiated

2024-09-18

Date posted

2024-11-13

Location

Minneapolis, MN