Recall Z-0372-2025 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Medtronic Neuromodulation
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
| Date | Nov 13, 2024 (initiated Sep 18, 2024) |
| Status | Open, Classified |
| Reason | The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use. |
| 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 co |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.