TactiCath™ PN-004075Recalls & reported problems

Summary

The FDA's MAUDE database contains 338 adverse event reports that list this exact device (DI 07640157990040), received between Jun 11, 2018 and Sep 21, 2023 — classified as 7 deaths, 46 injuries, 285 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (203 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 338 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT IS TO ADVISE OF A LEAK NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17788850 ↗
• MalfunctionAug 10, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT IS TO ADVISE OF A FLUID LEAK THAT WAS NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17497663 ↗
• MalfunctionJul 19, 2023Fluid/Blood Leak; Electrical Shorting; Fluid/Blood Leak; Electrical Shorting

  THIS REPORT IS TO ADVISE OF SHORT CIRCUITS AND A FLUID LEAK THAT WERE NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17350448 ↗
• MalfunctionApr 4, 2023Fluid/Blood Leak; Electrical Shorting; Fluid/Blood Leak; Electrical Shorting

  (B)(6) 2023 (B)(6) - THIS REPORT IS TO ADVISE OF FLUID LEAK AND MULTIPLE SHORT CIRCUITS NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16674741 ↗
• MalfunctionMar 23, 2023Fracture; Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16600162 ↗
• MalfunctionMar 23, 2023Electrical Shorting; Electrical Shorting

  THIS REPORT IS TO ADVISE OF A SHORT CIRCUIT NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16598809 ↗
• MalfunctionMar 22, 2023Fluid/Blood Leak; Electrical Shorting; Fluid/Blood Leak; Electrical Shorting

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS WHICH REVEALED A FLUID LEAK AS WELL AS MULTIPLE SHORT CIRCUITS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16593267 ↗
• MalfunctionMar 22, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS WHICH REVEALED A FLUID LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16592709 ↗
• MalfunctionMar 22, 2023Fracture; Fracture

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS WHICH REVEALED AN EXPOSED WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16592320 ↗
• MalfunctionMar 17, 2023Optical Problem; Optical Problem

  DURING THE SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, CONTACT FORCE ISSUES WHICH RESULTED IN PROCEDURAL DELAYS. THE CATHETER WAS EXCHANGED WITH NO RESOLUTION. THE CATHETER WAS EXCHANGED AGAIN AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. DURING THE PROCEDURE, AFTER CONNECTING THE CATHETER TO THE TACTISYS, IT WAS NOTED THAT THE CONTACT FORCE SIGNAL WAS NOT DISPLAYED ON THE SCREEN. THE TACTISYS WAS CHECKED REPEATEDLY AND THE INDICATOR LIGHT WAS RED. THE CATHETER WAS REPLACED, WITHOUT SOLVING THE ISSUE. THE CATHETER WAS EXCHANGED TO A THIRD ONE, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16567327 ↗
• MalfunctionMar 17, 2023Optical Problem; Optical Problem

  DURING THE SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, CONTACT FORCE ISSUES WHICH RESULTED IN PROCEDURAL DELAYS. THE CATHETER WAS EXCHANGED WITH NO RESOLUTION. THE CATHETER WAS EXCHANGED AGAIN AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. DURING THE PROCEDURE, AFTER CONNECTING THE CATHETER TO THE TACTISYS, IT WAS NOTED THAT THE CONTACT FORCE SIGNAL WAS NOT DISPLAYED ON THE SCREEN. THE TACTISYS WAS CHECKED REPEATEDLY AND THE INDICATOR LIGHT WAS RED. THE CATHETER WAS REPLACED, WITHOUT SOLVING THE ISSUE. THE CATHETER WAS EXCHANGED TO A THIRD ONE, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16567301 ↗
• MalfunctionMar 10, 2023Signal Artifact/Noise; Display or Visual Feedback Problem; Signal Artifact/Noise; Display or Visual Feedback Problem

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS WHICH REVEALED A SHORT CIRCUIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16521180 ↗
• MalfunctionMar 9, 2023Use of Device Problem; Optical Problem; Use of Device Problem; Optical Problem

  DURING AN ATRIAL TACHYCARDIA PROCEDURE, THE DEVICE USED DURING THE PROCEDURE HAD EXPIRED. DURING THE PROCEDURE, THE FIBER OPTIC CONNECTION DID NOT WORK WITH THE CATHETER. A TACTICATH SE DEVICE WAS USED WITH THE SAME SYSTEM TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16512726 ↗
• MalfunctionFeb 28, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS WHICH REVEALED A DISLODGED PULL WIRE AS WELL AS SHAFT MATERIAL THAT HAD BEEN SCRUNCHED AND DISTALLY DISPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16454639 ↗
• MalfunctionFeb 17, 2023Electrical Shorting; Electrical Shorting

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS WHICH REVEALED A SHORT CIRCUIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16398942 ↗
• MalfunctionFeb 1, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT IS TO ADVISE OF A LEAK NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16277828 ↗
• MalfunctionJan 30, 2023Use of Device Problem; Optical Problem; Use of Device Problem; Optical Problem

  DURING A PROCEDURE, AN EXPIRED CATHETER WAS USED. THE SENSING SYSTEM DID NOT WORK AS THE CONTACT FORCE VALUE COULD NOT BE CHECKED. AFTER CHANGING THE CATHETER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16269697 ↗
• MalfunctionJan 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, WHILE CHECKING THE CONNECTIONS OF THE CATHETER IT WAS NOTED THAT THE WATER CAME INTO THE CABLE OF THE CATHETER FROM THE PUMP TUBING. THE CATHETER WAS EXCHANGED TO CONTINUE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16218602 ↗
• MalfunctionJan 13, 2023Fluid/Blood Leak; Electrical Shorting; Fluid/Blood Leak; Electrical Shorting

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS WHICH REVEALED MULTIPLE SHORT CIRCUITS AND A LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16156946 ↗
• MalfunctionDec 23, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION SURGERY, IT WAS FOUND THAT THE OPTICAL FIBER OF THE TACTICATH QUARTZ ABLATION CATHETER WAS FLOODED, AND THE WATER FLOWED INTO THE PRESSURE MODULE. AFTER THE REPLACEMENT OF THE CATHETER, THE SURGERY WAS CARRIED OUT NORMALLY AND THE PATIENT HAD NO ADVERSE REACTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16044250 ↗
• MalfunctionNov 23, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS WHICH REVEALED A CONDUCTOR WIRE PROTRUDING OUT OF THE CATHETER SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15852553 ↗
• MalfunctionNov 14, 2022Fracture; Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE FOUND IN THE CATHETER DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15795095 ↗
• MalfunctionNov 4, 2022Optical Problem; Optical Problem

  THIS REPORT IS TO ADVISE OF A SHORT CIRCUIT AND LEAK FOUND DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15729684 ↗
• MalfunctionNov 1, 2022Fluid/Blood Leak; Electrical Shorting; Fluid/Blood Leak; Electrical Shorting

  THIS REPORT IS TO ADVISE OF SHORT CIRCUITS AND LEAKING FOUND DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15707748 ↗
• MalfunctionNov 1, 2022Fluid/Blood Leak; Electrical Shorting; Fluid/Blood Leak; Electrical Shorting

  THIS REPORT IS TO ADVISE OF A SHORT CIRCUIT AND FLUID INGRESS FOUND DURING ANALYSIS OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15707737 ↗