FARAWAVE™ NAV M004PF41M411Recalls & reported problems

Summary

The FDA's MAUDE database contains 417 adverse event reports that list this exact device (DI 00191506043193), received between Nov 18, 2024 and Sep 30, 2026 — classified as 11 deaths, 168 injuries, 238 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (80 reports).

5 other recalls cover devices cleared under the same FDA submission (P230030); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 417 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Entrapment of Device; Difficult to Remove; Blocked Connection; Material Twisted/Bent; Activation Failure

  It was reported that guidewire stuck, guidewire kink, guidewire lumen obstruction and deployment issue occurred. During an atrial fibrillation ablation procedure, a FARAWAVE catheter was selected for use. Multiple attempts to remove the guidewire from the catheter were unsuccessful. Troubleshooting efforts, including advancing and backloading the guidewire, were performed; however, resistance was encountered and the guidewire lumen appeared to be obstructed. FARAWAVE catheter deployment issue was also observed during use. FARAWAVE catheter was subsequently removed from the patient. Upon removal, the guidewire was noted to be kinked. FARAWAVE catheter was replaced with a new FARAWAVE catheter to complete the procedure without further issue. No patient complications were reported.It was further reported the splines were reported to be out of plane when the deployment issue was noted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952324 ↗
• MalfunctionSep 28, 2026Entrapment of Device; Material Twisted/Bent

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50914172 ↗
• InjurySep 22, 2026Off-Label Use

  Patient problems: Non specific EKG/ECG Changes; Tachycardia; Vasospasm

  MAUDE report 50862619 ↗
• MalfunctionSep 21, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848545 ↗
• InjurySep 21, 2026Off-Label Use; Adverse Event Without Identified Device or Use Problem

  It was reported that a patient experienced cerebral hemorrhage and aortic aneurysm. A Farawave Catheter was selected for use during a Pulsed Field Ablation (PFA) procedure. The procedure was completed with the device with not apparent issues; a non-Boston Scientific Sheath was used. The patient was discharged the day after the ablation procedure but then was readmitted several days later, at which time cerebral hemorrhage was confirmed. The reason for readmission was an aortic aneurysm in the groin. During readmission for an aortic aneurysm in the inguinal region, the patient's condition deteriorated, and a Magnetic Resonance Imaging (MRI) subsequently revealed a cerebral hemorrhage. The hospitalization period was estimated to be just under one week. Initially, it was suggested that the ablation may have caused a cerebral infarction, resulting in a cerebral haemorrhage. Subsequently, it was reported that the physician did not consider the cerebral haemorrhage to be causally related to the FARAPULSE procedure. It was confirmed that no cerebral infarction occurred. No other catheter was inserted into the heart at the time of the patient injury, and no resistance was felt during devi

  Patient problems: Aneurysm; Intracranial Hemorrhage

  MAUDE report 50846961 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced a pericardial effusion and required a pericardiocentesis tap. In the physician's opinion, the FARAWAVE Nav catheter caused the perforation. No further information was provided. The patient's condition is currently unknown.

  Patient problems: Pericardial Effusion

  MAUDE report 50840534 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It is reported that during a Pulmonary vein isolation (PVI) procedure for an atrial fibrillation treatment, a Farawave catheter was selected. It is reported that patient had a Watchman implant on (b)(6)2026. No abnormalities detected on 45-day Transesophageal Echocardiogram (TEE). Patient received a CT scan on (b)(6) 2026 in preparation for a PVI. Findings from the CT scan was a possible clot on the Watchman device. Patient was sent home on Eliquis and PVI was postponed. PVI was performed on (b)(6) 2026, no TEE was performed prior to PVI. Patient reported challenges walking following PVI to anesthesia provider. Patient returned to hospital for neuro scan (unknown which modality) on (b)(6) 2026. Findings from scan was possible prior stroke. Patient was discharged from hospital on (b)(6) 2026.

  Patient problems: Ischemia Stroke

  MAUDE report 50813102 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient experienced pericarditis, chest pain, abnormal renal laboratory results, and abnormal hematology results requiring medication.A FARAWAVE and FARAPOINT Pulsed Field Ablation Catheters were selected for use during a Pulsed Field Ablation (PFA) procedure. Following the procedure, the patient developed left-sided pleuritic chest pain radiating to the lateral chest with deep inspiration and was diagnosed with pericarditis. The patient had no history of similar pain and reported no shortness of breath, palpitations, or lightheadedness. No electrocardiogram (ECG) changes were observed. Diagnostic assessment included a chest X-ray with inspiratory and expiratory views, which did not demonstrate pneumothorax. To treat the pericarditis, the patient received paracetamol on (b)(6) 2026 and colchicine on (b)(6) 2026. Laboratory testing performed on (b)(6) 2026 demonstrated elevated creatinine (118 umol/L), elevated urea (8.4 mmol/L), elevated white blood cell count (13.1 x 10^9/L), elevated neutrophils (12.57 x 10^9/L), lymphocytes of 0.88 x 10^9/L, and red blood cell count (4.47 x 10^12/L). These findings were indicative of leukocytosis with neutrophilia and lymp

  Patient problems: Chest Pain; High White Blood Cell Count; Pericarditis; Renal Impairment

  MAUDE report 50809796 ↗
• MalfunctionSep 16, 2026Contamination

  It was reported that prior to procedure for a Pulse Field Ablation (PFA) procedure a FARAWAVE catheter was selected for use. Contamination was observed on the catheter handle. The catheter was replaced before use, and the procedure continued with another device. No patient involvement was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50790884 ↗
• MalfunctionSep 16, 2026Contamination

  It was reported that during test period for a Paroxysmal Atrial Fibrillation, a FARAWAVE catheter was selected for use, it was noticed the device was contaminated upon opening. The procedure completed with a replacement device (same model). No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50790275 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that ST Segment Augmentation, Vasospasm and Ventricular Fibrillation occurred.It was reported that a FARAWAVE NAV catheter was selected for a pulmonary vein isolation (PVI) to treat an atrial fibrillation (Afib). During procedure, ST elevation was noticed while ablation was being performed in the left lower pulmonary vein. The patient went into ventricular fibrillation (VFib) 3 times, and the patient was shocked each time. Nitro bolus was given, and a nitro drip was administered for the rest of the case. There was no audible sound like air being sucked through the sheath or catheter. No air was observed in a device or in the patient. It was informed that the probable cause for the ST elevation was coronary spasm. The ST elevation was noticed in all surface leads electrocardiogram (ECG). The patient was not admitted to the hospital, nor an existing hospitalization was extended. Product return is not expected as it was disposed.

  Patient problems: Non specific EKG/ECG Changes; Ventricular Fibrillation

  MAUDE report 50771869 ↗
• MalfunctionSep 14, 2026Contamination

  It was reported that contamination occurred. During the preparation for a pulse field ablation procedure for the treatment of atrial fibrillation, FARAWAVE catheter was selected for use. Upon opening the sterile package, a white substance was observed on the catheter handle. FARAWAVE catheter was replaced with a new FARAWAVE catheter to complete procedure without further issue. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50755256 ↗
• MalfunctionSep 11, 2026Contamination

  It was reported that during preparation for a Pulse Field Ablation (PFA) procedure for the treatment of atrial fibrillation, a FARAWAVE Nav catheter was selected for use. Upon removal of the catheter from its packaging, a white residue was noted on the handle. The residue appeared to be embedded within the handle material. The sterile seal was not damaged. The catheter was replaced and the procedure was completed successfully with no patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736547 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a pericardial tamponade occurred during a pulsed field ablation (PFA) procedure for the treatment of atrial fibrillation performed under general anesthesia. A FARAWAVE catheter was selected and used for the procedure. Bilateral pulmonary vein isolation was successfully achieved, sinus rhythm was restored via electrical cardioversion, and pulmonary vein block was subsequently confirmed. During the procedure, the patient developed a pericardial effusion accompanied by hypotension and hemodynamic instability. Emergent pericardiocentesis was performed, resulting in the drainage of approximately 2,660 mL of blood, of which 2,420 mL was autotransfused. The patient underwent resuscitative and stabilization measures and was subsequently transferred for emergency surgical intervention. According to the reporter, the event was attributed to mechanical stimulation associated with the FARAWAVE catheter. The patient required inpatient hospitalization/prolonged hospitalization, and the event remained ongoing at the time of the report. The patient's discharge date is not available.

  Patient problems: Cardiac Tamponade; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 50736518 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Seizure and Atrial Tachycardia occurred.It was reported that a FARAWAVE catheter and a FARADRIVE sheath were selected for ablation to treat atrial fibrillation (Afib). During procedure, FARAPULSE pulmonary vein isolation (PVI) and pulmonary wall isolation (PWI) were performed. An atrial tachycardia (AT) occurred, and chemical ablation was carried out. Non-Boston Scientific mapping and ablation catheters were inserted via FARADRIVE to continue the ablation. Mitral isthmus ablation was performed. The procedure was completed. There was a delayed recovery from general anesthesia, and it was reported that generalized convulsions occurred. A head computed tomography (CT) scan was performed. The findings revealed a pre-existing old cerebral infarction, but none other than that. The patient was transferred to the intensive care unit (ICU). As the sheath and other components remained in place, it was informed that the magnetic resonance imaging (MRI) scan was planned to be performed at a later date. As this could be an epileptic seizure, the patient's condition was monitored. Product return is not expected as it was discarded in facility.

  Patient problems: Convulsion/Seizure; Tachycardia

  MAUDE report 50736517 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced pericardial effusion.During a pulse field ablation (PFA) procedure to treat atrial fibrillation a FARAWAVE Nav catheter was used. It was noted that the patient had a patent foramen ovale which was crossed with a coronary sinus catheter. A therapeutic activated clotting time was maintained during the procedure. The procedure was completed and the FARAWAVE was removed from the patient, but during a routine post-procedure imaging sweep using Intracardiac Echocardiography (ICE) a pericardial effusion was observed at the basal right ventricle (RV). Pericardiocentesis was performed and the patient was admitted to the telemetry unit of the hospital. The current condition of the patient is unavailable.

  Patient problems: Pericardial Effusion

  MAUDE report 50731864 ↗
• MalfunctionSep 10, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50723855 ↗
• MalfunctionSep 10, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50717857 ↗
• MalfunctionSep 10, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50717269 ↗
• MalfunctionSep 10, 2026Air/Gas in Device

  It was reported that a Pulse Field Ablation (PFA) procedure was being performed using a FARAWAVE Catheter and a FARADRIVE Steerable Sheath Clear. After the FARAWAVE Catheter was inserted into the FARADRIVE Sheath, air aspiration was performed within the sheath. Despite repeated attempts, air continued to be aspirated from the catheter tip. Following sheath removal, the patient experienced ST-segment elevation, hypotension, and atrioventricular (AV) block. Noradrenaline was administered, and coronary angiography (CAG) was performed. Vasospasm was observed during CAG, and nitroglycerin was administered. Although vasospasm occurred, the relationship between the event and the device could not be determined. After the patient's condition stabilized, CAG reportedly demonstrated air ingress. The procedure was resumed, and both the FARAWAVE Catheter and FARADRIVE Steerable Sheath Clear were replaced with a second FARAWAVE Catheter and a second FARADRIVE Steerable Sheath Clear. Air aspiration was performed again; however, the same issue of continued air aspiration was reproduced. At the physician's discretion, the FARAWAVE Catheter was removed and replaced with a non-Boston Scientific PFA c

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716940 ↗
• InjurySep 10, 2026Air/Gas in Device

  It was reported that a Pulse Field Ablation (PFA) procedure was being performed using a FARAWAVE Catheter and a FARADRIVE Steerable Sheath Clear. After the FARAWAVE Catheter was inserted into the FARADRIVE Sheath, air aspiration was performed within the sheath. Despite repeated attempts, air continued to be aspirated from the catheter tip. Following sheath removal, the patient experienced ST-segment elevation, hypotension, and atrioventricular (AV) block. Noradrenaline was administered, and coronary angiography (CAG) was performed. Vasospasm was observed during CAG, and nitroglycerin was administered. Although vasospasm occurred, the relationship between the event and the device could not be determined. After the patient condition stabilized, CAG reportedly demonstrated air ingress. The procedure was resumed, and both the FARAWAVE Catheter and FARADRIVE Steerable Sheath Clear were replaced with a second FARAWAVE Catheter and a second FARADRIVE Steerable Sheath Clear. Air aspiration was performed again; however, the same issue of continued air aspiration was reproduced. At the physician discretion, the FARAWAVE Catheter was removed and replaced with a non-Boston Scientific PFA cathe

  Patient problems: Air Embolism; Heart Block; Low Blood Pressure/ Hypotension; Tachycardia; Vasospasm

  MAUDE report 50716780 ↗
• MalfunctionSep 10, 2026Contamination

  It was reported that in preparation/prior to procedure for a Atrial Fibrillation (Afib) procedure a FARAWAVE 2.0 catheter was selected for use, when opened, white substance was found. Procedure completed with another of same device. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716779 ↗
• MalfunctionSep 10, 2026Contamination

  It was reported that in preparation/prior to procedure for an Atrial Fibrillation (Afib) procedure a FARAWAVE 2.0 catheter was selected for use, when opened, white substance was found. Procedure completed with another of same device. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716539 ↗
• MalfunctionSep 10, 2026Contamination

  It was reported that contamination occurred. During the preparation for a pulse field ablation procedure for the treatment of atrial fibrillation, FARAWAVE catheter was selected for use. Upon opening the sterile package, a white substance was observed on the catheter handle. FARAWAVE catheter was replaced with a new FARAWAVE catheter to complete procedure without further issue. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50715198 ↗
• MalfunctionSep 10, 2026Contamination

  It was reported that the catheter had a white film on the handle.During preparation for a pulse field ablation (PFA) procedure to treat persistent atrial fibrillation a FARAWAVE catheter was selected for use. The device box was removed from the shipping box, but before being removed from the sterile packaging a white film on the catheter handle was observed. The sterile sleeve was removed and the device was inspected. A significant amount of white film that could be wiped away with a finger was noted. There was no damage or compromise of the sterile seal. The catheter was replaced and the procedure was completed. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713289 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P230030. One submission often covers many models, so check the product and lot details in each record.

• Z-2753-2026 · Jun 11, 2026 · Open, Classified
  FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
• Z-2750-2026 · Jun 11, 2026 · Open, Classified
  FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
• Z-2752-2026 · Jun 11, 2026 · Open, Classified
  FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter
• Z-2751-2026 · Jun 11, 2026 · Open, Classified
  FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter
• Z-2278-2025 · Jun 25, 2025 · Open, Classified
  FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401