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Interstim 3065USC

by Medtronic, Inc. 2 variants

Interstim 3065USC is a Class III device made by Medtronic, Inc., approved under FDA PMA P080025 on 14 Mar 2011 and listed in FDA GUDID since 23 Sep 2014 (UDI-DI 00613994572011), 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

3 ongoing

This device is named in the recall

Documents

PMA P080025

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 Number00613994572011 UDI-DI Date23 Sep 2014ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP080025 Date14 Mar 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P080025 decided 14 Mar 2011 Active
  • FDA GUDID UDI-DI 00613994572011 listed 23 Sep 2014 Listed

Recalls

5 recalls · 3 ongoing · FDA

    • Ongoing Z-1704-2025 FDA Class II initiated 3 Apr 2025

    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.

    • Ongoing Z-0372-2025 FDA Class II initiated 18 Sep 2024 on shared PMA P080025

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

    • Ongoing Z-2365-2023 FDA Class II initiated 6 Jul 2023

    Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with the incorrect expiration date.

    • 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 P080025

    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.

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 P080025
  2. Listed FDA GUDID 00613994572011
  3. Recall initiated FDA recalls Z-1147-2015
  4. Recall initiated FDA recalls Z-0998-2022
  5. Recall initiated FDA recalls Z-2365-2023
  6. Recall initiated FDA recalls Z-0372-2025
  7. Recall initiated FDA recalls Z-1704-2025

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
Sacral plexus percutaneous incontinence-control electrical stimulation system electrode
Model / reference
3065USC
Primary DI / UDI-DI
00613994572011
PMA number
FDA product code
EZW
GMDN term
Sacral plexus percutaneous incontinence-control electrical stimulation system electrode
Device class
Class III
Regulation number
876.5270
GUDID distribution status
In Commercial Distribution

Related devices

Category: Sacral plexus percutaneous incontinence-control electrical stimulation system electrode

Cleared under the same submission (P080025)

and 8 more cleared under P080025

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (11, all answered No)