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Verify™ 353101

by Medtronic, Inc. 4 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

3 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00763000993313 UDI-DI Date2 Jul 2026ListedStatusListed GUDID: in commercial distribution

Recalls

7 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.

    • 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.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Verify™
Generic Name
Sacral plexus percutaneous incontinence-control electrical stimulation system pulse generator
Model / Reference
353101
Primary DI / UDI-DI
00763000993313
PMA Number
FDA Product Code
QON, EZW
GMDN Term
Sacral plexus percutaneous incontinence-control electrical stimulation system pulse generator
Device Class
Class III
Regulation Number
876.5270
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (P080025)

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Cleared under the same submission (P970004)

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Other devices from Medtronic, Inc.

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Properties

  • Single Use
  • Prescription Use
  • Serial Number

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No