Medtronic Neuromodulation: Medical Device Recall in 2024 - (Recall #: Z-0372-2025)
See the recall detail below. You can also see other recalls from the same firm in 2024.
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
Class II
The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use.
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.
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.
Voluntary: Firm initiated