# 3560019

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/na-3560019-9a8d6a56>
- Manufacturer: [Medtronic, Inc.](https://devicerts.com/manufacturers/medtronic-inc) (United States)
- Device class: Class III (US FDA)
- FDA product code: EZW, QON
- GMDN: Personal device holder, single-use (31072)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 00643169103207 · listed 2014-09-23 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA PMA · United States · P080025 · decision 2011-03-14 · decision APPR · status: Active · from GUDID
- **GUDID** · FDA PMA · United States · P970004 · decision 1997-09-29 · decision APPR · status: Active · from GUDID

## Recalls

- Z-1704-2025 · Class II · ongoing · initiated 2025-04-03: Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause the therapy to stop being delivered and a system error will be displayed. Patient may experience return of underlying disease symptoms (e.g. overactive bladder, urinary retention, or fecal incontinence) based on their response to stimulation during the evaluation period.
- Z-0372-2025 · Class II · ongoing · initiated 2024-09-18 · matched through shared submission P080025, may concern other models: The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use.
- Z-2365-2023 · Class II · ongoing · initiated 2023-07-06: Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with the incorrect expiration date.
- Z-0998-2022 · Class II · terminated · initiated 2022-02-28: 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 retained and a " Data Lost" notification being displayed.
- Z-1147-2015 · Class II · terminated · initiated 2015-01-09 · matched through shared submission P080025, may concern other models: Current labeling indicates that cycling improves device longevity in every programming scenario. However, enabling cycling at certain parameter settings may decrease the device battery longevity. With cycling enabled, longevity estimate displayed on the Model 8840Programmer may be inaccurate.
- Z-0037-2008 ·  · terminated · initiated 2007-06-25: A software issue may cause a lower than expected battery capacity estimate when evaluating an InterStim II Implantable Neurostimulator (model 3058) with an N'Vision Clinician Programmer(Model 8840) before implant .
- Z-0040-2008 ·  · terminated · initiated 2007-06-25: Software issue may cause false low battery alert to be displayed when interrogating an Interstim Implantable Neurostimulator (Model 3023) with an N'Vision Clinician Programmer (Model 8840), or with an Inter Stim iCon Patient Programmer (Model 3037).

## Identity

- Generic name: Personal device holder, single-use [FDA GUDID (AccessGUDID)]
- Model / reference: 3560019 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00643169103207 [FDA GUDID (AccessGUDID)]
- PMA number: P080025 [FDA GUDID (AccessGUDID)]; P970004 [FDA GUDID (AccessGUDID)]
- FDA product code: EZW [FDA GUDID (AccessGUDID)]; QON [FDA GUDID (AccessGUDID)]
- GMDN term: Personal device holder, single-use (31072) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class III [FDA GUDID (AccessGUDID)]
- Regulation number: 876.5270 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Single use: Yes [FDA GUDID (AccessGUDID)]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: 3560019, Medtronic, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/na-3560019-9a8d6a56 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/na-3560019-9a8d6a56.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/na-3560019-9a8d6a56
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.