QDOT MICRORecalls & reported problems across all models

We found 7 models of QDOT MICRO by Biosense Webster Inc in the FDA's device registry (GUDID). Together they are named in 1,418 adverse event reports in the FDA's MAUDE database, received between Jul 28, 2021 and Sep 30, 2026 — classified as 42 deaths, 541 injuries, 835 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (547 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported QDOT MICRO problems

QDOT MICRO models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• QDOT MICRO D139505

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  27 deaths915 reports
• QDOT MICRO D139402

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  3 deaths171 reports
• QDOT MICRO D139504

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  7 deaths138 reports
• QDOT MICRO D139401

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  2 deaths114 reports
• QDOT MICRO D139501

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  2 deaths73 reports
• QDOT MICRO D139403

  Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
  1 death6 reports
• QDOT MICRO D139502

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  1 report

Recent QDOT MICRO adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Obstruction of Flow; Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50955040 ↗
• InjurySep 30, 2026Patient Device Interaction Problem

  It was reported that a patient underwent a premature ventricular contraction ablation procedure with a QDOT MICRO Catheter and the patient experienced a cardiac tamponade which required pericardiocentesis.After the ablation, during hemostasis, ST elevation occurred, and echocardiography revealed pericardial effusion. The patient recovered after drainage of the pericardial fluid. The patient has fully recovered.No error message observed on the Biosense Webster equipment during the procedure. Transseptal puncture was not performed. No ablations performed within the Pulmonary Veins. No evidence of a steam pop. The flow setting was set to Pre:2sec, Post: 0sec. The correct catheter settings were selected on the generator. No issues with flow rate change at the start of the ablation. Physician¿s assessment of health hazard is non-serious (moderate/minor). There were no abnormalities observed during product use. The physician¿s opinion on the cause of this adverse event is that upon post-procedural review of the fluoroscopy images, the physician observed that cardiac motion appeared to worsen around the time of Coronary Sinus (CS) catheter insertion. Therefore, the physician believes that

  Patient problems: Cardiac Tamponade

  MAUDE report 50941987 ↗
• InjurySep 28, 2026Patient Device Interaction Problem

  Patient problems: Heart Block

  MAUDE report 50926586 ↗
• MalfunctionSep 28, 2026Insufficient Cooling; Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923022 ↗
• InjurySep 28, 2026Patient Device Interaction Problem

  Patient problems: Cardiac Tamponade

  MAUDE report 50922550 ↗
• InjurySep 24, 2026Patient Device Interaction Problem

  It was reported that a patient underwent a cardiac ablation procedure with a QDOT MICRO Catheter and the patient experienced heart block.In the Kent¿s bundle on septum procedure, an atrioventricular (AV) block occurred during around the fourth ablation from the aorta. The ablation time was about seven seconds at 20W. The patient had not progressed to a complete AV block. Since it was not a complete block, the patient was awakened and was placed under observation. The patient required prolonged hospitalization.Physician assessment of the health problem is non-serious (moderate/minor). The physician's opinion on the relationship between the event and the product is that the physician considered the issue unrelated to the product. There were no abnormalities observed prior to or during use of the product.

  Patient problems: Heart Block

  MAUDE report 50889246 ↗
• InjurySep 24, 2026Patient Device Interaction Problem

  It was reported that during a clinical study, the patient received index cardiac ablation on (b)(6) 2026 for ischemic ventricular tachycardia. On (b)(6) 2026, patient experienced left atrial appendage thrombus (AE#1) categorized as moderate and not serious. Relationship to study device is not related and relationship to the index study procedure is possible. The outcome is ongoing. Intervention was medication (apixaban).

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50877529 ↗
• MalfunctionSep 23, 2026Insufficient Cooling

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50875925 ↗
• InjurySep 23, 2026Patient Device Interaction Problem

  It was reported that a patient underwent an atrial fibrillation ablation with a QDOT Micro Catheter and the patient experienced cardiac arrest/asystole that required CPR (cardiopulmonary resuscitation).After ablating, (pulmonary vein isolation--posterior wall with the Farawave and cavotricuspid isthmus with the QDOT), the patient's heart stopped with a rapid drop in blood pressure. CPR was started and a TEE (transesophageal echocardiogram) was performed--no effusion was noted. The patient's vital signs eventually returned to baseline after about 10 minutes. The patient fully recovered but required extended hospitalization (the doctor wanted to keep the patient overnight to monitor him).The event occurred after catheters and sheaths were removed at the end of the procedure. The physician believes it was an allergic reaction to protamine.

  Patient problems: Asystole; Cardiac Arrest

  MAUDE report 50872908 ↗
• MalfunctionSep 22, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50857486 ↗
• DeathSep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent an Atrial Fibrillation ablation procedure with a QDOT MICRO Catheter and a Watchman Appendage closure wherein the patient experienced cardiac arrest that required Cardiopulmonary Resuscitation (CPR), pacing and ECMO, ventricular fibrillation that required cardioversion, and hemorrhage. The patient expired.At the conclusion of Atrial fibrillation ablation, during the process of extubating, patient developed bradycardia followed by hypotension. Soon after, loss of pulse was noted by anesthesiologist and CPR was started. X-ray showed that the right ventricle was not moving. No effusion was noted via trans-esophageal echocardiogram (TEE). Pulse was noted after initial CPR for a short period. Transvenous pacemaker catheter was inserted. Patient developed ventricular fibrillation soon after and shocked to restore sinus rhythm was performed. Extracorporeal membrane oxygenation was inserted with normalization of blood pressure. However, abdominal distention was noted by echocardiogram that there was blood around the patient¿s liver. Decision was made to have a CT, results are unknown. Patient was placed in the intensive care unit where he passed awa

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Ventricular Fibrillation

  MAUDE report 50781131 ↗
• MalfunctionAug 28, 2026Positioning Problem; Patient Device Interaction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50501745 ↗
• InjuryJul 31, 2026Patient Device Interaction Problem

  It was reported that a patient underwent a device implant with AV (atrioventricular) node ablation with a QDOT MICRO catheter and the patient experienced cardiac tamponade that required pericardiocentesis.After being transferred to the inpatient unit post-procedure, the patient was noted to have hypotension. A bedside echo noted a pericardial effusion. A pericardiocentesis was performed with approximately 250mL of fluid removed.The physician doesn't think the issue is due to the ablation portion of the procedure. There were no high force readings or any other issues noted during ablation (3 minutes total ablation time). It was also reported that the patient had a Bi-V pacemaker implanted prior to ablation. During positioning of the CS (coronary sinus) lead during the device implant, contrast was not used due to patient allergy.

  Patient problems: Cardiac Tamponade

  MAUDE report 50106839 ↗
• InjuryJul 30, 2026Patient Device Interaction Problem

  It was reported that a patient underwent a cardiac ablation and the patient experienced cardiac tamponade that required drainage.Cavotricuspid isthmus (CTI) ablation was performed using the QDOT MICRO Catheter and VIZIGO Short. Brockenbrough (BB) was performed using the Soundstar eco catheter. Pulmonary vein isolation (PVI) was performed using the VARIPULSE Catheter, and post-mapping of the left atrium (LA) was performed using OCTARAY. After completion of these procedures, the physician observed a decrease in blood pressure, confirmed using echocardiography, which revealed pericardial effusion. The patient's blood pressure recovered and stabilized after drainage, and the patient left the room.It was stated that the drained blood was venous blood, so the issue might have been related to ablation near the inferior vena cava (IVC), during CTI ablation, or to coronary sinus (CS) catheter insertion.Visitag coloring setting was Tag index. Visitag additional filter used was FOT. Force visualization features were used were CF, Realtime Graph, Vector, Visitag. Parameters for stability were: range: 3mm, time: 3sec, FOT: 25%5g, tag size: 2mm. Procedural activated clotting time was 350 seconds

  Patient problems: Cardiac Tamponade

  MAUDE report 50091230 ↗
• DeathJun 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (BILATERAL PVI AND POSTERIOR WALL ISOLATION WERE PERFORMED) ABLATION WITH A QDOT MICRO CATHETER AND THE PATIENT EXPERIENCED ESOPHAGEAL FISTULA THAT RESULTED IN DEATH. FIFTEEN DAYS POST PROCEDURE THE PATIENT HAD DEVELOPED A LEFT ATRIUM ESOPHAGEAL FISTULA. AT THE TIME OF THE EMERGENCY CALL, THE PATIENT WAS CONSCIOUS AND MADE THE EMERGENCY REQUEST INDEPENDENTLY. THE CHIEF COMPLAINTS AT THE TIME OF THE CALL WERE CHEST PAIN AND FEVER. BY THE TIME THE AMBULANCE ARRIVED, THE PATIENT HAD DEVELOPED IMPAIRED CONSCIOUSNESS. UPON ARRIVAL AT THE HOSPITAL, THE PATIENT WAS ABLE TO SPEAK; HOWEVER, CONVERSATIONS WERE OFTEN INCOHERENT. RIGHT-SIDED PARALYSIS WAS CONFIRMED. A BRAIN MRI AND WHOLE-BODY CT WERE PERFORMED. THE MRI REVEALED SCATTERED MICRO CEREBRAL INFARCTIONS AND THE CT SHOWED THE PRESENCE OF AIR IN THE TRUNK REGION (AROUND THE AORTA). GIVEN THE HISTORY OF ATRIAL FIBRILLATION ABLATION PROCEDURE, A LEFT ATRIAL¿ESOPHAGEAL FISTULA WAS STRONGLY SUSPECTED. EMERGENCY SURGERY WAS PERFORMED. DESPITE TWO DAYS OF HOSPITALIZATION THEREAFTER, THE PATIENT DID NOT IMPROVE AND DIED DURING ADMISSION. IT WAS REPORTED THAT THE CAUSE OF DEATH W

  Patient problems: Air Embolism; Fistula; Hemorrhage/Blood Loss/Bleeding; Stroke/CVA

  MAUDE report 25670686 ↗

Other Biosense Webster Inc products

• THERMOCOOL SMARTTOUCH SF8 models · 6,238 reports · 1 recall
• VIZIGO3 models · 5,206 reports · 4 recalls
• ThermoCool SmartTouch7 models · 1,163 reports
• PENTARAY NAV12 models · 842 reports · 4 recalls
• OCTARAY Mapping Catheter6 models · 407 reports
• CARTO VIZIGO2 models · 349 reports
• SOUNDSTAR6 models · 260 reports
• PREFACE3 models · 193 reports