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Tacticath Quartz Ablation Catheter

by St Jude Medical PMA

Active United States

PMA P130026

Overview

The Tacticath Quartz Ablation Catheter is a percutaneous cardiac ablation catheter designed for electrophysiological mapping and the treatment of drug-refractory recurrent symptomatic paroxysmal atrial fibrillation. It delivers controlled radiofrequency energy to create precise tissue ablation, facilitating rhythm restoration in eligible patients.

This device is intended for use in conjunction with a compatible radiofrequency generator and three-dimensional mapping system within an electrophysiology laboratory setting. It is supplied as a single-use device and has received FDA Premarket Approval (PMA). The catheter is available in multiple reference codes and must be stored according to manufacturer instructions to maintain sterility and performance.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP130026 Date24 Oct 2014ApprovedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA PMA Active

Recalls

6 recalls · 1 ongoing · FDA

    • Ongoing Z-0814-2024 FDA Class II initiated 18 Dec 2023

    When the catheters are used with the EnSiteX EP System, the system does not correctly recognize the catheter as the appropriate product model and instead reads and displays it as a different model. This results in some features specific to the catheter do not appear on the display and the catheter image may also appear inverted.

  • 2 recalls, same reason

    • Terminated Z-0956-2022 FDA Class II initiated 24 Mar 2022
    • Terminated Z-0957-2022 FDA Class II initiated 24 Mar 2022

    Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.

    • Terminated Z-2541-2020 FDA Class II initiated 22 May 2020

    High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter

    • Terminated Z-1493-2019 FDA Class II initiated 5 Apr 2019

    In reported cases, the device log on the TactiSys Quartz Equipment operating on Software Version 1.7.0 fills the allocated disk space, which prevents the storage of new log data. This may lead to intermittent contact force data to be displayed during the procedure.

    • Terminated Z-1284-2015 FDA Class II initiated 25 Nov 2014

    A configuration update needs to be done on TactiSys to appropriately recognize all TactiCath catheters.

Specification

PMA

Trade Name
Tacticath Quartz Set
Generic Name
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
PMA Number
FDA Product Code
OAE
Device Class
Class III
Advisory Committee
Cardiovascular
FDA Decision
APPR Approved

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Questions

  • What is the primary clinical use of the Tacticath Quartz Ablation Catheter in an electrophysiology lab setting?

    The Tacticath Quartz Ablation Catheter is designed specifically for **electrophysiological mapping and the treatment of drug-refractory recurrent symptomatic paroxysmal atrial fibrillation**. It delivers controlled radiofrequency energy to create precise tissue ablation, helping to restore normal heart rhythm in eligible patients. It requires use with a compatible radiofrequency generator and a three-dimensional mapping system.

  • Is the Tacticath Quartz Ablation Catheter intended for reuse, or is it a single-use device?

    The Tacticath Quartz Ablation Catheter is **supplied as a single-use device**, meaning it is not designed for reuse. Proper storage according to manufacturer instructions is required to maintain sterility and performance.

  • How many different reference codes or models are available for the Tacticath Quartz Ablation Catheter?

    The device is available in **multiple reference codes**, with over **50 distinct FEI numbers** listed in regulatory records (e.g., 1721676, 3005334138, etc.). These likely correspond to variations in catheter design, length, or other specifications. For exact model details, refer to the manufacturer’s product catalog.

  • What regulatory pathway was followed for FDA approval of the Tacticath Quartz Ablation Catheter?

    The Tacticath Quartz Ablation Catheter received **FDA Premarket Approval (PMA)** under PMA number **P130026**, indicating a rigorous review process for Class III devices. Approval was granted on **October 24, 2014**, following submission to the FDA’s Cardiovascular (CV) advisory committee.