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Interstim® 3023

by Medtronic, Inc. 2 variants

Interstim® 3023 is a Class III device made by Medtronic, Inc., approved under FDA PMA P970004 on 29 Sep 1997 and listed in FDA GUDID since 23 Sep 2014 (UDI-DI 00613994287731), active as of 23 Oct 2026. 3 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

1 ongoing

Recall on shared PMA P970004; other models may be affected

Documents

PMA P970004

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00613994287731 UDI-DI Date23 Sep 2014ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP970004 Date29 Sep 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P970004 decided 29 Sep 1997 Active
  • FDA GUDID UDI-DI 00613994287731 listed 23 Sep 2014 Listed

Recalls

5 recalls · 1 ongoing · FDA

    • Ongoing Z-0372-2025 FDA Class II initiated 18 Sep 2024 on shared PMA P970004

    The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use.

    • Terminated Z-0998-2022 FDA Class II initiated 28 Feb 2022

    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.

    • Terminated Z-1147-2015 FDA Class II initiated 9 Jan 2015 on shared PMA P970004

    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.

    • Terminated Z-0037-2008 FDA Unclassified (pre-2012) initiated 25 Jun 2007

    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 .

    • Terminated Z-0040-2008 FDA Unclassified (pre-2012) initiated 25 Jun 2007

    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).

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

7 dated events

  1. Approved FDA PMA P970004
  2. Recall initiated FDA recalls Z-0037-2008
  3. Recall initiated FDA recalls Z-0040-2008
  4. Listed FDA GUDID 00613994287731
  5. Recall initiated FDA recalls Z-1147-2015
  6. Recall initiated FDA recalls Z-0998-2022
  7. Recall initiated FDA recalls Z-0372-2025

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

GUDID

Trade name
Interstim®
Generic name
Implantable incontinence-control electrical stimulation system pulse generator
Model / reference
3023
Primary DI / UDI-DI
00613994287731
PMA number
FDA product code
EZW, QON
GMDN term
Implantable incontinence-control electrical stimulation system pulse generator
Device class
Class III
Regulation number
876.5270
GUDID distribution status
In Commercial Distribution

Related devices

Category: Sacral plexus implantable incontinence-control electrical stimulation system

Cleared under the same submission (P970004)

and 8 more cleared under P970004

Similar devices

Other devices filed under FDA product code QON.

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Serial number
Other properties (10, all answered No)