N/A (REF 7000D)Recalls & reported problems

Innovative Health LLC · Polaris X Steerable Diagnostic EP Catheter 105 cm Standard Curve 10 Electrodes 2.5 mm Spacing 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 10841898111877), received between Jun 14, 2024 and Jun 14, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Reprocessing Problem” (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

Device Reprocessing Problem1

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.

MalfunctionJun 14, 2024Device Reprocessing Problem; Device Reprocessing Problem
THE DEVICE WAS REPORTED TO HAVE A RED/ENCRUSTED SUBSTANCE ON THE TIP THAT WOULD NOT WIPE OFF. THE SUBSTANCE WAS IDENTIFIED AFTER REMOVAL FROM THE PATIENT. THE CASE WAS COMPLETED WITHOUT INCIDENT. NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19538134 ↗

Device details

UDI-DI	`10841898111877`
Brand	N/A
Model	N/A
Catalog no.	7000D
Company	Innovative Health LLC
Product code	NLH · Catheter, Recording, Electrode, Reprocessed
Class	Class 2
FDA submission	K160303
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	Jul 6, 2018

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.