N/A (REF D135304)Recalls & reported problems

Innovative Health LLC · Webster CS Uni-Directional Diagnostic EP Catheter 6F · Class 2

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 10841898125409), received between Oct 30, 2024 and Oct 30, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Detachment of Device or Device Component1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionOct 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2024, IT WAS REPORTED THAT IT LOOKS LIKE THE CABLE MIGHT HAVE GOTTEN STUCK IN THE CATHETER AND THE CONNECTOR BROKE UPON REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20570665 ↗

Device details

UDI-DI	`10841898125409`
Brand	N/A
Model	N/A
Catalog no.	D135304
Company	Innovative Health LLC
Product code	NLH · Catheter, Recording, Electrode, Reprocessed
Class	Class 2
FDA submission	K170922, K203655
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 12, 2023

Device type (GMDN): Cardiac mapping catheter, percutaneous, reprocessed

A sterile, steerable, flexible tube containing multiple electrodes that is introduced percutaneously into the heart chambers in order to transmit electrical impulses for electrophysiological diagnostic examinations, e.g., intracardiac sensing, endocardial recording, stimulation, temporary pacing for evaluation of cardiac arrhythmias and cardioversion (CV), and electrophysiology (EP) mapping. It is typically made of plastic with embedded electrodes often of platinum (Pt), iridium, or a composite. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application.

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