Home › Device types › EZW
Stimulator, Electrical, Implantable, For Incontinence
FDA product code EZW · Class 3 · Gastroenterology, Urology
278
Registered devices
82,553
Adverse events
9
Recalls
0
510(k) clearances
Devices with this code
NA — MEDTRONIC, INC.INTERSTIM® — MEDTRONIC, INC.Axonics — AXONICS MODULATION TECHNOLOGIES, INC.INTERSTIM — MEDTRONIC, INC.N/A — MEDTRONIC, INC.N/A — MEDTRONIC, INC.InterStim™
SureScan™ — MEDTRONIC, INC.NA — MEDTRONIC, INC.INTERSTIM® — MEDTRONIC, INC.NA — MEDTRONIC, INC.INTERSTIM® — MEDTRONIC, INC.NA — MEDTRONIC, INC.Axonics — AXONICS MODULATION TECHNOLOGIES, INC.INTERSTIM® — MEDTRONIC, INC.N/A — MEDTRONIC, INC.Neuspera SNM System — NeuSpera Medical Inc.Neuspera SNM System — NeuSpera Medical Inc.NA — MEDTRONIC, INC.INTERSTIM® — MEDTRONIC, INC.INTERSTIM® — MEDTRONIC, INC.N'VISION® — MEDTRONIC, INC.Neuspera SNM System — NeuSpera Medical Inc.Axonics — AXONICS MODULATION TECHNOLOGIES, INC.N'Vision — MEDTRONIC, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-03 | Medtronic Neuromodulation | Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability t |
| 2024-06-17 | Medtronic Neuromodulation | A subset of the handsets within the kit may not be able to complete the pairing process with the communicator upon initial setup. |
| 2023-07-06 | Medtronic Neuromodulation | Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with the incorrect expiration date. |
| 2022-02-28 | Medtronic Neuromodulation | There is a software anomaly with the InterStim X Clinician software application with results in the data entered in the Patient Information fields not e retaine |
| 2021-11-04 | Medtronic Neuromodulation | The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient Us |
| 2019-05-15 | Medtronic Neuromodulation | There is a potential for an unexpected increase in stimulation during InterStim programming with the A10 Clinician Application (on Medtronic's smart programmer) |
| 2008-05-12 | Medtronic Neuromodulation | Medtronic is retrieving four (4) patient programmers that were not properly loaded with application software. The application software is needed for a patient |
| 2007-06-25 | Medtronic Neuromodulation | Software issue may cause false low battery alert to be displayed when interrogating an Interstim Implantable Neurostimulator (Model 3023) with an N'Vision Clini |
| 2007-06-25 | Medtronic Neuromodulation | A software issue may cause a lower than expected battery capacity estimate when evaluating an InterStim II Implantable Neurostimulator (model 3058) with an N'Vi |
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