FARAWAVE™ M004PF41M401Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,515 adverse event reports that list this exact device (DI 00191506043148), received between Apr 25, 2024 and Sep 23, 2026 — classified as 39 deaths, 491 injuries, 985 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (377 reports).

1 FDA recall record name this device's identifier, 1 still open.

4 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 16, 2026.

Recalls naming this device

1. Jun 25, 2025Open, Classified

   The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.

   Z-2278-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,515 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Off-Label Use

  During a procedure, a FARAWAVE and VersaCross Connect transseptal access product were selected for use. During the procedure, a total of 97 ablation applications were delivered, including 82 lesions to the pulmonary veins and posterior wall and 15 lesions to the Cavotricuspid Isthmus. Due to the high lesion count, the physician administered 1.5 L of intravenous fluids intraoperatively. No malfunctions were reported at this time. Following the procedure, the patient developed hematuria, and the physician indicated that the high number of ablation applications may have contributed to hemolysis and the subsequent hematuria. As a result, the patient was admitted to the hospital for overnight observation and received additional intravenous fluids. No diagnostic test results related to hemolysis were available. The hematuria resolved after treatment, and the patient was discharged the following day with no additional complications reported.

  Patient problems: Hematuria; Hemolysis

  MAUDE report 50869894 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hemothorax; Tachycardia

  MAUDE report 50828934 ↗
• InjurySep 10, 2026Air/Gas in Device

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 50724638 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  During a pulmonary vein isolation (PVI) and posterior wall isolation (PWI) procedure for the treatment of atrial fibrillation, a FARAWAVE catheter and an NRG Access Solution needle were selected. Following the procedure, the patient was reported to have blood in the urine. Laboratory testing was performed and hemolysis markers were reported as positive. As a result, the patient's discharge was postponed for hydration and observation. The patient was discharged the following day without further reported issues.

  Patient problems: Hematuria; Hemolysis

  MAUDE report 50674497 ↗
• MalfunctionSep 8, 2026Entrapment of Device; Off-Label Use

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50672781 ↗
• DeathSep 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Death, Cardiac Arrest, Ventricular Fibrillation, Ventricular Tachycardia, Hypotension and Bradycardia occurred.A concomitant procedure (ablation/left atrial appendage closure (LAAC)) was being performed. A WATCHMAN TruSteer Access System (WAS), a 31mm WATCHMAN FLX Pro LAA Closure Device and Delivery System (WDS), a FARAWAVE catheter and a VersaCross Connect Access Solution for FARADRIVE were selected for use. After the ablation portion of the procedure, the LAAC procedure was completed without any reported complications. Electrocardiogram (EKG) monitoring showed no ST-segment elevation or evidence of any lethal arrhythmias. At the conclusion of the procedure, the physician was in the process of closing the groin access site, and protamine was administered to reverse the effects of heparin anticoagulation. The anesthesia physician observed a sudden decline in the patient's blood pressure along with bradycardia. Cardiopulmonary resuscitation (CPR) was initiated. A transesophageal echocardiogram (TEE) was performed to evaluate for a potential pericardial effusion or cardiac tamponade as a cause of the hemodynamic instability. No pericardial effusion was identified

  Patient problems: Bradycardia; Cardiac Arrest; Low Blood Pressure/ Hypotension; Tachycardia; Ventricular Fibrillation

  MAUDE report 50671284 ↗
• MalfunctionSep 8, 2026Entrapment of Device

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50670859 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Hemolysis occurred.It was reported that a FARAWAVE catheter was selected for ablation to treat an atrial fibrillation (Afib). No device issues were reported during procedure. Post procedure, it was informed that the patient underwent dialysis due to hemolysis. The complication likely occurred due to high number of ablations; 150 ablations were performed. The patient exhibited any clinical signs or symptoms related to hemolysis. The patient was admitted to the hospital, or an existing hospitalization was extended due to the complication. The patient has been discharged. Product return is not expected as it was disposed. It was further informed that which diagnostics tests were performed and their results are not available per account. Which specifics clinical signs or symptoms related to hemolysis the patient exhibited are not available per account. And the lot number of the device was reported as not available per account.

  Patient problems: Hemolysis

  MAUDE report 50670768 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced pericardial effusion, perforation of the left atrial appendage (LAA), and a drop in blood pressure.During a pulse field ablation (PFA) procedure to treat atrial fibrillation a FARAWAVE catheter was used. The transseptal puncture was performed, then a non-Boston Scientific catheter and sheath were inserted to perform pre-mapping. Resistance was felt when manipulating these devices anteriorly. Once the pre-map was complete the FARAWAVE catheter was introduced via the non-Boston Scientific sheath. After four ablation deliveries to the left superior pulmonary vein (LSPV) with the catheter a significant drop in blood pressure occurred with systolic pressure in the mid-60s. Intracardiac echocardiography (ICE) was used to check for pericardial effusion, and a significant pericardial effusion was observed. The catheter and sheath were then removed from the left atrium (LA), and protamine was given because it was decided to cancel the procedure. Pericardiocentesis was performed and 2L of blood was removed. The patient was sent afterwards to the operating room (OP) for a sternotomy. The cardiothoracic surgeon noted there was significant bleeding c

  Patient problems: Cardiac Perforation; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 50613360 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  After a Pulse Field Ablation (PFA) procedure for the treatment of paroxysmal atrial fibrillation using a FARAWAVE catheter, the patient experienced a worsening of a pre-existing atrial fibrillation. Subsequently an RF ablation (re-ablation) was performed on the pulmonary vein (RIPV), superior vena cava, and tricuspid-inferior vena cava isthmus. Following the procedure, the patient's condition improved.

  Patient problems: Atrial Fibrillation

  MAUDE report 50602340 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient experienced atrial fibrillation.After a Pulse Field Ablation (PFA) procedure to treat atrial fibrillation where a FARAWAVE 31 was selected for use a worsening of the Atrial Fibrillation occurred. PFA and RF ablation (repeat ablation) were performed (targeting the pulmonary veins Right Superior Pulmonary Vein (RSPV), Right Inferior Pulmonary Vein (RIPV) and cavotricuspid isthmus (CTI)) to resolve the issue. Both Pulmonary Vein Isolation (PVI) and CTI ablation were performed using a FARAWAVE catheter and an RF catheter. However, the customer/account was unable to specify which device was used for the CTI ablation. The patient's condition subsequently improved. This case is reported to be associated with worsening of the patients pre-existing condition of atrial fibrillation (AF). No specific medication administered for the worsening atrial fibrillation event was reported. The worsening of pre-existing atrial fibrillation occurred on (b)(6) 2025 after the first PFA procedure performed on (b)(6) 2025. The atrial fibrillation event did not result in hospitalization or prolonged hospitalization. Procedure was completed using the same device. It was indicate

  Patient problems: Atrial Fibrillation

  MAUDE report 50601438 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem; Air/Gas in Device

  Patient problems: Air Embolism; Non specific EKG/ECG Changes

  MAUDE report 50600223 ↗
• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient experienced a cardiac tamponade requiring a pericardiocentesis and extended hospitalization.A FARAPULSE procedure was performed and completed on (b)(6) 2026. A VERSACROSS Connect for FARADRIVE was used for the transeptal puncture portion of the procedure. The FARADRIVE sheath and a FARAWAVE catheter were used with a Merit guidewire for the ablation portion of the procedure. Following the completion of the procedure, the patient reported shortness of breath and chest pain. The physician ordered an Echocardiography and observed a cardiac tamponade. A pericardiocentesis was performed, removing 300 cc of fluid. The patient was hospitalized. The physician reported that the patient had a small right inferior pulmonary vein and a small heart. The patient was finally discharged on 06Aug2026. All symptoms are absent and patient is in Normal Sinus Rhythm.

  Patient problems: Cardiac Tamponade; Chest Pain; Discomfort; Respiratory Insufficiency

  MAUDE report 50599402 ↗
• InjurySep 3, 2026Off-Label Use

  During an ablation procedure, a FARAWAVE was selected for use. Use of the catheter to treat cavo tricuspid isthmus and superior vena cava, constituted off-label use of the catheter. During procedure, a total of 87 ablations were performed at the pulmonary veins, posterior wall, cavo tricuspid isthmus and superior vena cava locations. The patient presented to the Emergency Room approximately 24 hours after the procedure due issues urinating- hemolysis. Diagnostic testing showed trace blood in the urine with 1 red blood cell/HPF, haptoglobin <10, bilirubin 4.1, LDH 4.69, and creatinine 0.8. The patient exhibited clinical signs consistent with hemolysis, including urinary retention. In response, the patient was admitted to the hospital and treated with intravenous (IV) fluids. The adverse event was considered possibly related to the catheter, although no device malfunction was noted. The patient condition improved, resulting in recovery and discharge from the hospital.

  Patient problems: Hemolysis; Urinary Retention

  MAUDE report 50584144 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that for a Pulse Field Ablation (PFA) procedure to treat atrial fibrillation a Rhythmia Umbilical Cable ST was selected for use. Patient had PVI/PW ablation on in (b)(6) with a Farawave catheter. The patient arrived at the hospital 3 days later with an atrial tachycardia (AT). Atrial tachycardia ablation scheduled 11 days after the patient presented to Hospital in AT. Patient arrived for the AT procedure. The physician performed transeptal. Attached Orion to signal station to condition. Opal recorded an error message. Not ready to condition, error detected with the catheter magnetic sensor coil. Orion was exchanged for a second catheter. Same error. First umbilical cable was exchanged for a second cable. Same error. Drove to a second hospital to retrieve another Orion and cable. While gone, colleagues rebooted SiS, workstation, re-seated cables, moved back patch. Nothing worked. Upon arrival 30 minutes later with a third Orion and cable, hooked up third Orion catheter. Same error. Replaced the cable for the third time and was finally able to condition the catheter and finish the procedure. No patient complications were reported. The patient was sedated, and transept

  Patient problems: Tachycardia

  MAUDE report 50548192 ↗
• MalfunctionAug 24, 2026Fluid/Blood Leak

  It was reported that for a Pulse Field Ablation (PFA) procedure to treat a persistent atrial fibrillation a FARAWAVE Ablation Catheter was selected for use. The catheter was prepared with no issues noted. No spline bunching, fluid leakage, or guidewire resistance was observed during preparation. After six applications were delivered in basket configuration within the left superior pulmonary vein, the physician observed excessive fluid on the patient drape and catheter handle. No air was observed entering the patient. The catheter was removed from the patient, and upon inverting the handle, fluid was observed exiting from the orange slider switch. The catheter was replaced and the procedure was successfully completed using the replacement device. No patient complications occurred, and the patient remained stable throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50410424 ↗
• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that for a Pulse Field Ablation (PFA) procedure to treat a non-paroxysmal atrial fibrillation, a FARAWAVE Catheter was selected for use. Post-procedure, the patient experienced cardiac tamponade. The procedure was completed with the device. Treatment for the event was not reported; however, hospitalization or prolonged hospitalization was indicated. The patient recovered on (b)(6)2025.

  Patient problems: Cardiac Tamponade

  MAUDE report 50278467 ↗
• InjuryAug 17, 2026Off-Label Use; Adverse Event Without Identified Device or Use Problem

  A hypotension is reportedDuring a pulmonary vein isolation for an atrial fibrillation procedure, a Farawave catheter and a VERSACROSS CONNECT were selected. During procedure, a patient received a Pulsed Field ablation with the Farawave catheter on the Cavotricuspid Isthmus (CTI). 2mg of nitro was given as an infusion and then the CTI was ablated with 9 applications with no issues. Transseptal was performed, Left Atrium was mapped and Farawave was inserted into the left atrium and Left Superior Pulmonary Vein. 1 application was delivered in basket, and the patient had an approximately 15-20s cardiac pause is classified as an arrhythmia followed by profound hypotension. Hypotension was treated with epinephrine and eventually resolved. Procedure was incomplete, canceled, or rescheduled. After procedure as patient was being woken up, there appeared to be changes to ST segments confirming a ST Elevation. Patient was sent to cath (cardiac catheterization) lab for a cath procedure to determine status of coronaries. Cath did not show noticeable coronary vasospasm.

  Patient problems: Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes; Syncope/Fainting; Vasospasm

  MAUDE report 50269216 ↗
• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  It has been reported that exertional angina pectoris has occurred post procedure. During pulse field ablation procedure to treat paroxysmal atrial fibrillation FARAWAVE was selected for use. The patient's condition is improving. This case was reported as a worsening of the patient's pre-existing condition (other than AF) and was considered related to the procedure (vascular access). The device is not expected to be returning as it has been disposed.

  Patient problems: Angina

  MAUDE report 50228388 ↗
• DeathAug 12, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a death occurred.A FARAWAVE Catheter was selected for use during pulsed field ablation. It has been mentioned that the patient died. The cause of death is unknown. No patient complications occurred during the procedure. Per physician, the Boston Scientific device or procedure did not cause or contribute to the patient's death.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 50223090 ↗
• InjuryAug 7, 2026Off-Label Use

  It was reported that the catheter was used off label and months later the patient experienced worsening atrial fibrillation requiring a re-ablation procedure.During a pulse field ablation (PFA) procedure to treat non-paroxysmal atrial fibrillation a FARAWAVE catheter was used. Ablation was performed on the left superior pulmonary vein (LSPV), left carina, right superior pulmonary vein (RSPV), cardiac floor, cardiac roof, the left atrial posterior wall (LAPW), and the right atrium (RA) septal. Use of the catheter to treat non-paroxysmal atrial fibrillation and to ablate the left carina, cardiac floor and roof, the LAPW, and the RA septal constituted off label use of the device. The procedure was completed successfully with no patient complications at the time.Almost four months after the procedure, on 2-October-2025, the patient experienced atrial fibrillation that was attributed to the worsening of the patient's pre-existing atrial fibrillation. It was noted that the patient was hospitalized, though the reason for and the duration of the hospitalization is unknown. A re-ablation procedure using PFA was performed on the superior vena cava, and the patient's condition improved in the

  Patient problems: Atrial Fibrillation

  MAUDE report 50173961 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Atrial Fibrillation occurred.It was reported that a FARAWAVE catheter was selected for a pulse field ablation (PFA) to treat a paroxysmal atrial fibrillation (PAF). Post procedure, atrial fibrillation occurred. Electrical cardioversion was performed, and the patient's condition improved. The event was reported to be related to an exacerbation of the patient's pre-existing atrial fibrillation (AF). Product return is not expected as it was discarded. It was informed that the patient's condition has improved.

  Patient problems: Atrial Fibrillation

  MAUDE report 50156522 ↗
• MalfunctionAug 5, 2026Restricted Flow rate

  It was reported that FARAWAVE Catheter was selected for use during pulmonary vein isolation to treat atrial fibrillation. It has been mentioned that mid way through the procedure, the catheter was not dripping even when staff had the drip on for the catheter. Re flushed and wired the catheter and still no drip. The procedure was completed using different device (same model). No patient complications occurred.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50144839 ↗
• MalfunctionAug 4, 2026Contamination; Difficult to Flush

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50132109 ↗
• InjuryJul 31, 2026Off-Label Use; Adverse Event Without Identified Device or Use Problem

  It was reported that a patient experienced a ST segment elevation, ventricular tachycardia and an arrhythmia. During a PFA ablation procedure, a FARAWAVE catheter was selected, and pulmonary vein isolation (PVI) and posterior wall isolation (PWI) were completed in the left atrium. The patient was believed to be in typical atrial flutter at the time, which did not terminate with ablation. The procedure then moved to the right atrium, where a Cavotricuspid Isthmus (CTI) line was created using the FARAWAVE catheter. The FARAWAVE catheter had been removed and reinserted twice during the case. No prophylactic nitroglycerin was administered, and no acute ST segment changes were initially noted. While pacing to assess CTI block, the patient developed ventricular tachycardia (VT). Initially, it was suspected that pacing induced the VT, however, review of the intracardiac electrograms suggested pacing was not the cause. Review of the ECGs demonstrated ST segment elevation in leads V1 and V2 that was already present on the pre procedure ECG, indicating the finding was likely preexisting rather than procedure related. The VT morphology was consistent with an origin from the left ventricular a

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

  MAUDE report 50105591 ↗

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-2752-2026 · Jun 11, 2026 · Open, Classified
  FARASTAR PFA Generator, Product ID M004PFCE61M460; 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-2751-2026 · Jun 11, 2026 · Open, Classified
  FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter