IontoPatch STATRecalls & reported problems

LTS Therapy Systems, LLC · The IontoPatch contains an innovative self-contained battery that produces an electric current to carry drug molecules non-invasively across the skin and to underlying tissue. There is no need for an external power source. Drug delivery is shut off automatically when the prescribed dosage has been administered. The IontoPatch is single use and disposable. Since there are no external batteries or wires, patients are able to return to their daily activities wearing the patch and receiving time-released iontophoresis. · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K992708); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

May 22, 2025Open, Classified
The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.
Z-2196-2025 · Root cause: Under Investigation by firm · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K992708. One submission often covers many models, so check the product and lot details in each record.

Z-2197-2025 · May 22, 2025 · Open, Classified
IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch.
Z-0454-2022 · Nov 10, 2021 · Terminated
iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear Time, 6/1-patch pouches/box. Dosage: 120mA/min.

Device details

UDI-DI	`10815611020005`
Brand	IontoPatch
Model	STAT
Company	LTS Therapy Systems, LLC
Product code	EGJ · Device, Iontophoresis, Other Uses
Class	Class 2
FDA submission	K992708
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 25, 2023

Device type (GMDN): Drug-delivery iontophoresis patch

A non-sterile device designed as a patch that is fixed on the skin, typically with a pressure-sensitive adhesive, intended to be used as an alternative to injections for the transport of ionic-solution medication (e.g., soluble salts) through the movement of ions, resulting from an applied electric field, to locally administer the medication transcutaneously (transdermal). It typically consists of a positive and a negative electrode, a reservoir/drug chamber(s) that hold the medication, a battery, and a perimeter adhesive; the reservoir must be filled by the user with the drug prior to use. This is a single-use device.

Other Device, Iontophoresis, Other Uses devices

IontoPatch 80
LTS Therapy Systems, LLC · Device, Iontophoresis, Other Uses
1 recall0 reports
ActivaPatch 001-40
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1 report
ActivaPatch IontoGo 4.0 001-50
Activatek Inc. · Device, Iontophoresis, Other Uses
1 report
CHATTANOOGA 5000022
Djo, LLC · Device, Iontophoresis, Other Uses
1 report

All Device, Iontophoresis, Other Uses devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.