Travanti STATRecalls & reported problems

LTS Therapy Systems, LLC · This kit contains two (2) devices: 1) IontoPatch: Primary DI Number, 10815611020005 2) Saline: Primary DI Number, 04026704396047 The IontoPatch is single use and disposable. The patch is used in conjunction with the saline.

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20815611021009), received between Mar 13, 2019 and Mar 13, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (1 report).

3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

Material Protrusion/Extrusion1

Patient problems

Burn, Thermal1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionMar 13, 2019Material Protrusion/Extrusion
PT BEING TREATED FOR LEFT LATERAL EPICONDYLITIS: THE PATH HAD EXPOSED METAL. THIS CAUSED A BURN, SLIGHTLY SMALLER THAN A DIME. UPON EXAMINATION, WOUND HAD SCABBED OVER AND NO SIGNS OF INFECTION. PT REPORTS NO PAIN. LOCATION WHERE EVENT OCCURRED: OUTPATIENT TREATMENT FACILITY - PHYSICAL THERAPY.
Patient problems: Burn, Thermal
MAUDE report 8424840 ↗

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-2196-2025 · May 22, 2025 · Open, Classified
IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch.
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	`20815611021009`
Brand	Travanti
Model	STAT
Company	LTS Therapy Systems, LLC
Product code	—
Class	—
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.

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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