Regulatory status

as of 24 Oct 2026

Recall ongoing. 3 ongoing FDA recalls. See recalls

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00763000879273 UDI-DI	Date27 Jun 2024Listed	StatusIn distribution

Coverage

1 jurisdiction

Listed
Not covered

United States — GUDID listing Listed

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 via P080025, on the same PMA
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 via P080025, on the same PMA
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 marked "via" name another device cleared under the same FDA submission as this one.

Specification

GUDID · synced 23 Oct 2026

Trade Name: Verify™
Generic Name: Sacral plexus percutaneous incontinence-control electrical stimulation system pulse generator
Model / Reference: 353101

Primary DI / UDI-DI: 00763000879273
PMA Number: P080025
P970004
FDA Product Code: EZW, QON
GMDN Term: Sacral plexus percutaneous incontinence-control electrical stimulation system pulse generator

Device Class: Class III
Regulation Number: 876.5270
Commercial Distribution: In Commercial Distribution

Category: Sacral plexus percutaneous incontinence-control electrical stimulation system pulse generator

Cleared under the same submission (P080025)

Show all (12)

Cleared under the same submission (P970004)

Show all (12)

Verify® External Neurostimulator 353101 Class III
VERIFY™ 3531 Class III
Verify™ 353101 Class III
Verify® 353101 Class III
Verify® 353101 Class III

Properties & raw data

Show properties, registry sources and raw records

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

Sources (1)

FDA UDI b80916c6-2b09-4ce9-a6b3-7060a26dbd0c 35 fields · synced 23 Oct 2026