Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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

FDA Recall Z-0372-2025 · Posted 2024-11-13

Recall StatusOpen, Classified
Product CodeLGW
Date Initiated2024-09-18
Product Quantity118 wireless rechargers

Reason for Recall

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

Firm Action

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

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑