Skip to content
Recall Observatory FDA recall evidence

Device 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

Z-0372-2025

September 18, 2024

Class II

Product summary

Firm
Medtronic Neuromodulation
Event
Event 95465
Status
Ongoing
Classification
Class II
Quantity
118 wireless rechargers
Official record key
device-enforcement:Z-0372-2025

Official wording

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

Code information: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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