TactiCath™ Quartz 65Recalls & reported problems

Summary

The FDA's MAUDE database contains 131 adverse event reports that list this exact device (DI 07640157990033), received between Jun 15, 2018 and Jun 6, 2023 — classified as 2 deaths, 23 injuries, 106 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (67 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 131 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17075766 ↗
• MalfunctionNov 16, 2022Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15804231 ↗
• MalfunctionOct 20, 2022Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15639369 ↗
• MalfunctionOct 4, 2022Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15541320 ↗
• MalfunctionSep 30, 2022Fracture; Fracture

  THIS REPORT IS TO ADVISE OF AN EXPOSED WIRE NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15519586 ↗
• MalfunctionSep 8, 2022Fluid/Blood Leak; Electrical Shorting; Fluid/Blood Leak; Electrical Shorting

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15381404 ↗
• MalfunctionSep 7, 2022Optical Problem; Optical Problem

  THIS REPORT IS TO ADVISE OF AN EXPOSED WIRE FOUND DURING ANALYSIS. THERE WERE NO ADVERSE CONSEQUENCES REPORTED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15369862 ↗
• MalfunctionSep 2, 2022Signal Artifact/Noise; Use of Device Problem; Signal Artifact/Noise; Use of Device Problem

  DURING THE AF PROCEDURE, NOISE WAS NOTED. THE CATHETER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. IN REVIEW OF THE FILE, IT WAS DETERMINED THE DEVICE USED PAST THE EXPIRATION DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15349248 ↗
• MalfunctionAug 2, 2022Optical Problem; Optical Problem

  RELATED MANUFACTURING REF 9680001-2022-00031. DURING AN ATRIAL FIBRILLATION PROCEDURE, THE CONTACT FORCE WOULD NOT DISPLAY RESULTING IN CANCELLATION OF THE PROCEDURE. THERE WAS NO FORCE DISPLAYED WITH THE FIRST CATHETER. A SECOND CATHETER WAS OBTAINED WHICH HAD THE SAME ISSUE. THE TACTISYS QUARTZ WAS THEN EXCHANGED WHICH DID NOT RESOLVE THE ISSUE. AFTER HALF AN HOUR OF TROUBLESHOOTING, IT WAS DECIDED TO CANCEL THE PROCEDURE, WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15149080 ↗
• MalfunctionJul 29, 2022Optical Problem; Optical Problem

  RELATED MANUFACTURING REF 9680001-2022-00032. DURING AN ATRIAL FIBRILLATION PROCEDURE, THE CONTACT FORCE WOULD NOT DISPLAY RESULTING IN CANCELLATION OF THE PROCEDURE. THERE WAS NO FORCE DISPLAYED WITH THE FIRST CATHETER. A SECOND CATHETER WAS OBTAINED WHICH HAD THE SAME ISSUE. THE TACTISYS QUARTZ WAS THEN EXCHANGED WHICH DID NOT RESOLVE THE ISSUE. AFTER HALF AN HOUR OF TROUBLESHOOTING, IT WAS DECIDED TO CANCEL THE PROCEDURE, WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15128996 ↗
• MalfunctionJun 12, 2022Communication or Transmission Problem; Communication or Transmission Problem

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING A FRACTURE AT THE CATHETER SHAFT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14672703 ↗
• MalfunctionMay 27, 2022Fracture; Fracture

  THIS REPORT IS TO ADVISE OF AN EVENT NOTED DURING ANALYSIS WHICH REVEALED EXPOSED WIRES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14523511 ↗
• MalfunctionMay 27, 2022Electrical Shorting; Material Deformation; Optical Problem; Electrical Shorting; Material Deformation; Optical Problem

  THIS REPORT IS TO ADVISE OF A DISPLACED ELECTRODE NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14523205 ↗
• MalfunctionMay 25, 2022Fracture; Fracture

  THIS REPORT IS BEING SUBMITTED BASED ON ANALYSIS WHICH REVEALED A FRACTURE IN THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14496381 ↗
• MalfunctionMay 24, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING AN IRRIGATION LEAK OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14492791 ↗
• MalfunctionMay 24, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING AN IRRIGATION LEAK OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14487469 ↗
• MalfunctionMay 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT IS TO ADVISE OF AN EVENT NOTED DURING ANALYSIS WHICH REVEALED A LEAK IN THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14428314 ↗
• MalfunctionApr 13, 2022Failure to Deliver Energy; Failure to Deliver Energy

  THIS EVENT IS BEING REPORTED BASED ON ANALYSIS OF THE CATHETER WHICH REVEALED AN EXPOSED WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14104123 ↗
• MalfunctionMar 10, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THIS EVENT IS BEING REPORTED DUE TO A LEAK IN THE CATHETER NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13720354 ↗
• MalfunctionMar 8, 2022Material Deformation; Material Deformation

  THIS EVENT IS BEING REPORTED BASED ON ANALYSIS WHICH REVEALED A DISPLACED ELECTRODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13694335 ↗
• MalfunctionFeb 4, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING AN IRRIGATION LEAK OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13456716 ↗
• MalfunctionJan 28, 2022Material Frayed; Material Frayed

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING EXPOSED INTERNAL WIRES OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13385765 ↗
• InjuryDec 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL TACHYCARDIA AND PULMONARY VEIN ISOLATION ABLATION PROCEDURE, DURING THE LEFT-SIDED ATRIAL ABLATION, A CARDIAC TAMPONADE WAS NOTED. THE CARDIAC TAMPONADE WAS THOUGHT TO HAVE OCCURRED ANTERIOR TO THE RIGHT SUPERIOR PULMONARY VEIN, NEAR THE ROOF. DURING MAPPING AND ABLATION, THE ABLATION CATHETER LEFT THE ATRIUM AT THE SUPERIOR PORTION OF THE SEPTAL REGION OF THE LEFT ATRIUM, ANTERIOR TO THE RIGHT SUPERIOR PULMONARY VEIN. AS THERE WERE NO PATIENT SYMPTOMS AND AN ECHOCARDIOGRAM DID NOT REVEAL ANY PERICARDIAL EFFUSION, THE PHYSICIAN ASSUMED THAT THERE WAS AN ADDITIONAL PULMONARY VEIN THERE. ABLATION WAS THEN PERFORMED AT THAT SITE. FOLLOWING THE ABLATION, THE PATIENT THEN BECAME HYPOTENSIVE AND THEIR OXYGEN SATURATION DECREASED. THE PATIENT THEN LOST CONSCIOUSNESS AND AN ECHOCARDIOGRAM SHOWED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS THEN PERFORMED AND PROTAMINE WAS ADMINISTERED. THE PROCEDURE WAS THEN CANCELLED AND THE PATIENT WAS ADMITTED TO THE INTENSE CARE UNIT WITH A PERICARDIAL DRAIN. TWO HOURS LATER THE PATIENT WAS NOTED TO BE IN A STABLE CONDITION. THERE WERE NO PERFORMANCE ISSUES WITH THE ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 13052841 ↗
• MalfunctionNov 30, 2021Electrical Shorting; Electrical Shorting

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12893380 ↗
• MalfunctionNov 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING A LEAK OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12865284 ↗