Z-0372-2025Class II

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

Name: Z-0372-2025 Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for...
Creator: Medtronic Neuromodulation
Published: 2024-09-18
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2024-09-18 / Open, Classified

FDA source

Medtronic Neuromodulation began a recall of Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The... on 2024-09-18. FDA classified it as Class II and gives the reason as "The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0372-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-18
Posted: 2024-11-13
Recalling firm: Medtronic Neuromodulation
Product: 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
Product code: LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Reason for recall: The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use.
FDA root cause: Under Investigation by 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.
Quantity in commerce: 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, Ireland, Italy, Japan, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and United Kingdom.
Product codes and lots: RS6230 - GTIN 00763000564353, Serial numbers: NRA010637N; NRA011389N; NRA013260N; NRA013664N; NRA013924N; NRA014318N; NRA014347N; NRA015823N; NRA015861N; NRA015864N; NRA016334N; NRA016413N; NRA016430N; NRA016432N; NRA016778N; RA017002N; NRA017048N; NRA017227N; NRA017232N; NRA017685N; NRA018697N; NRA018731N; NRA018906N; NRA018936N; NRA018992N; NRA019019N; NRA019026N; NRA019963N; NRA019967N; NRA019968N; NRA019970N; NRA019983N; NRA010657N; NRA012367N; NRA012898N; NRA012915N; NRA013490N; NRA013643N; NRA013877N; NRA013878N; NRA013880N; NRA014248N; NRA014741N; NRA015127N; NRA015142N, NRA010659N; NRA010661N; NRA010663N NRA016424N; NRA016425N; NRA016426N; NRA016431N; RA016433N; NRA021324N. RS7230 - GTIN 00763000540289, Serial numbers: NRA010640N; NRA010650N; NRA010656N: NRA011591N; NRA012896N; NRA012910N; NRA012925N; NRA013884N; NRA010633N; NRA010635N; NRA010641N; NRA010642N; NRA010646N; NRA010652N; NRA010653N; NRA010654N; NRA010655N; NRA010658N; NRA010660N; NRA010664N; NRA010666N; NRA010667N; NRA010668N; NRA010669N; NRA010881N; NRA011216N; NRA011293N; NRA011393N; NRA011713N; NRA011853N; NRA012184N; NRA012897N; NRA012909N; NRA012911N; NRA012912N; NRA012913N; NRA012914N; NRA013502N; NRA013602N; NRA013603N; NRA013634N; NRA013635N; NRA013638N; NRA013639N; NRA013879N; NRA013883N; NRA013899N; NRA013952N; NRA014259N; NRA014944N; NRA015858N; NRA015904N; NRA011189N; NRA011238N; NRA012130N; NRA012185N; NRA012366N; NRA013543N; NRA014132N; NRA014222N; GTIN 0763000827533, Serial numbers: NRA010558N; NRA010627N; NRA015360N; NRA013633N.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0372-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0372-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-13

Product code LGW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)