Recall record at a glance
| Official record | Z-0372-2025 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Medtronic Neuromodulation |
| Report date | Nov 20, 2024 |
| Recall initiation date | Sep 18, 2024 |
| Quantity | 118 wireless rechargers |
| Location | Minneapolis, MN, United States |
Official product description
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
Why the product was recalled
The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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