FARAWAVE™ M004PF41M431Recalls & reported problems

Summary

The FDA's MAUDE database contains 272 adverse event reports that list this exact device (DI 00191506043216), received between May 15, 2025 and Sep 30, 2026 — classified as 11 deaths, 113 injuries, 148 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (49 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 272 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Off-Label Use; Material Twisted/Bent

  Patient problems: Cardiac Arrest

  MAUDE report 50953994 ↗
• MalfunctionSep 30, 2026Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948446 ↗
• MalfunctionSep 30, 2026Air/Gas in Device

  It was reported that visible air bubbles were observed. During preparation for the pulmonary vein isolation procedure, FARAWAVE catheter was selected for use. During device preparation, visible air bubbles were observed within the plastic molding of the connection piece on the catheter flush line. The flush port was connected and evaluated, and no leakage was observed. The device was subsequently used to complete the procedure as intended. The guidewire was appropriately retracted flush with the distal end of the catheter prior to sheath insertion. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948443 ↗
• MalfunctionSep 30, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941530 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Anemia; Hematuria; Hemolysis

  MAUDE report 50896115 ↗
• MalfunctionSep 24, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890130 ↗
• MalfunctionSep 24, 2026Entrapment of Device; Material Twisted/Bent; Activation Failure

  It was reported that during the pulse field ablation procedure to treat paroxysmal atrial fibrillation FARAWAVE was selected for use. It has been mentioned that when attempting to deploy into basket splines bunched. The physician was unable to put into flower then unable to bring into basket again. Wire stuck out and unable to bring back in. Eventually the physician was able to collapse catheter and bring into sheath. The procedure was completed successfully by using a different device (same model, Boston Scientific product). No patient complications have been reported. The product is expected to be returned.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888797 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during a Pulse Field Ablation (PFA) procedure for the treatment of atrial fibrillation (AF), a FARAWAVE catheter was selected for use. Pulmonary vein isolation and posterior wall ablation were completed in the left atrium. The patient was then cardioverted (DCCV) to normal sinus rhythm (NSR) to allow pacing in the right atrium for assessment of conduction block across a previously created cavotricuspid isthmus (CTI) line. The patient subsequently returned to AF and required a second DCCV to allow further CTI assessment. The physician determined that the CTI line from the previous procedure appeared blocked. The patient again returned to AF, and the physician proceeded with superior vena cava (SVC) ablation, delivering four basket applications and four flower applications. Following SVC isolation, the patient was cardioverted again and was noted to be bradycardic with a junctional escape rhythm of 20 bpm. Pacing was performed through the coronary sinus (CS) catheter at cycle lengths of 600 ms, 1000 ms, and 1200 ms. Glycopyrrolate 0.2 mg was administered, after which the patient's intrinsic rhythm exceeded the paced rate, and pacing was discontinued. After awaken

  Patient problems: Arrhythmia; Bradycardia

  MAUDE report 50870458 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that an allergic reaction occurred.A pulse field ablation procedure with transseptal puncture was performed using FARADRIVE sheath, FARAWAVE catheter and VersaCross Connect Radio Frequency (RF) wire. Immediately post procedure, patient became hypotensive, tachycardic and hypoxic. Protamine was reversed, saline was administered and a Transesophageal Echocardiogram (TEE) was performed. No pericardial effusion was observed, and patient began recovering and was admitted to the Intensive Care unit (ICU) for monitoring. The physician suspected that an allergic reaction to protamine had occurred. The patient was discharged from the hospital one day post index procedure.It was further reported that patient was discharged from the hospital one-day post index procedure.

  Patient problems: Hypersensitivity/Allergic reaction; Hypoxia; Low Blood Pressure/ Hypotension; Tachycardia

  MAUDE report 50856294 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Pericardial effusion occurred. FARAWAVE Catheter was selected for use during farapulse pulsed field ablation. It has been mentioned that patient arrived in flutter during an Atrial fibrillation ablation under deep sedation. The ICE Catheter was introduced into right atrium and then right ventricle and scanned noting a baseline effusion around the basal aspect of the right ventricle. Transeptal was performed without issue noted and visualized under ICE. The ICE Catheter was introduced into the left atrium. A decapolar Coronary Sinus catheter was then placed into the Coronary sinus. An eccentric activation pattern was noted and suspected roof dependent flutter. All 4 veins were isolated and the flutter persisted. A posterior wall isolation was performed. Termination occurred during an application in flower. Pressures dropped following conversion and anesthesia noted they were not responding to pressors. The Farapulse catheter and Faradrive sheath were removed from the LA. ICE was then pulled back to the Right atrium and scanned the pericardium. An increase in the pericardial effusion was noted to approximately 1cm. Heparinization was reversed and anesthesia suppo

  Patient problems: Atrial Flutter; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 50841251 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  The patient experienced liver dysfunction.It was reported that a FARAWAVE was selected for use. The patient experienced elevated liver enzyme levels (AST/ALT) one day following the index procedure date. Chemical Cardioversion (Furosemide injection Add on bepridil) and Electrical Cardioversion (shock) were performed. The patient was admitted to the hospital on (b)(6) 2026 and was discharged on (b)(6) 2026.

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 50787037 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient experienced pericardial effusion.During a procedure to treat atrial fibrillation and a Watchman implant a Farawave was selected for use. A trivial effusion around the right ventricle (RV) was noted on Intracardiac echocardiography (ICE) by the physician prior to start of the Radiofrequency (RF) ablation with a non-Boston Scientific device. A cavotricuspid isthmus (CTI) ablation was performed using a non-Boston Scientific RF catheter prior to the transeptal, prior to the insertion of a Faradrive Sheath and Farawave Catheter for the Pulse Field Ablation. Physician stated to have heard a steam pop with the RF ablation. CTI ablation was completed with non-Boston Scientific RF catheter. The physician exchanged the non-Boston Scientific sheath for another non-Boston Scientific device and performed a transeptal with a non-Boston Scientific device using fluoroscopy and ICE guidance. A non-Boston Scientific was exchanged for the Faradrive Sheath over a 230cm BSC Starter Rosen J wire. The wire could be visualized on ICE and fluoroscopy position in the common left pulmonary vein during sheath exchange. The Farawave catheter was advanced over the wire into the le

  Patient problems: Pericardial Effusion

  MAUDE report 50754467 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient experienced ST-segment elevation requiring medication.During a pulmonary vein isolation procedure to treat paroxysmal atrial fibrillation (AF), a FARAWAVE Ablation Catheter was selected for use. The patient was under general anesthesia and pharmacologically paralyzed. Transseptal access was obtained using a VersaCross RF wire through a non-Boston Scientific sheath and dilator. Following removal of the wire and dilator, a FARAWAVE catheter was advanced into the left atrium. The transseptal sheath was not connected to irrigation, and the irrigation of the FARAWAVE catheter was not interrupted while the device was in use. No audible sound suggestive of air being drawn through the sheath or catheter was noted, and no air was visualized within the device or patient. After catheter insertion and prior to ablation, ST-segment elevation was observed in the limb leads on electrocardiogram (ECG). Review of the pre-procedure ECG confirmed that no ST-segment elevation had been present prior to the procedure. The physician reported the cause of the ST-segment elevation was unknown. Nitroglycerin was administered, resulting in resolution of the ST-segment elevation

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 50733801 ↗
• MalfunctionSep 9, 2026Contamination; Off-Label Use; Activation, Positioning or Separation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50694777 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that pericardial effusion and hypotension occurred. It was reported that a pulmonary vein isolation (PVI) procedure was performed using the FARAWAVE Catheter for pulse field ablation (PFA) and the VersaCross Connect Access Solution for FARADRIVE under deep sedation. The patient had difficult vascular access. Following unsuccessful guidewire insertion through the left sided vascular access site, all three access sites were established on the right side for placement of the intracardiac echocardiography (ICE) catheter, FARADRIVE sheath, and ablation catheter. Based on ICE imaging, the physician noted that the patient's left atrium appeared smaller than usual. The VersaCross Connect Access Solution for FARADRIVE was then used to obtain transseptal access. During the transseptal procedure, the physician rewired the superior vena cava (SVC) multiple times using the VersaCross pigtail guidewire. The guidewire was also reported to have dropped down several times while the physician experienced difficulty identifying septal tenting. The physician subsequently observed that the pigtail guidewire had crossed the septum and entered the left atrium without delivery of radiofreq

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 50693700 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  During a persistent atrial fibrillation ablation procedure, a FARAWAVE 2.0 Catheter was selected for use and introduced through a non-Boston Scientific 13 Fr sheath. During the initial insertion of the catheter, a suspected air embolism occurred, resulting in hypotension and inferior ST-segment elevation observed on a 12-lead ECG while ablation was being performed at the left superior pulmonary vein. No malfunction of the FARAWAVE catheter was noted, and the catheter had not been removed and reinserted prior to the event. The patient was under general anesthesia without apneic episodes, high tidal volume, or any known condition that could have contributed to negative intrathoracic pressure. Interventions included increasing the fraction of inspired oxygen (FiO2), administration of intravenous nitroglycerin, observation, and termination of the procedure. The ST-segment elevation resolved completely prior to case completion; however, the cause of the ST-segment elevation remains unknown. No imaging was performed, and no air was visualized within the patient. Additionally, no neurological or cardiac complications were reported. The patient remained neurologically intact, followed comm

  Patient problems: Air Embolism; Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes

  MAUDE report 50671610 ↗
• MalfunctionSep 8, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50670558 ↗
• MalfunctionSep 7, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50656845 ↗
• MalfunctionSep 4, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602451 ↗
• MalfunctionSep 4, 2026Entrapment of Device; Material Twisted/Bent

  It was reported that during an ablation procedure, a Farawave catheter was selected for use. After advancing device into Left Superior Pulmonary Vein and ablating in basket, the device presented spline bunching in flower and the wire was stuck. Changing the catheter deployment state did not resolve the guidewire issue. The guidewire was removed from the back. The procedure was completed using a replacement catheter. No patient complications were reported. The device is not expected to be returned as it was disposed of.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602069 ↗
• MalfunctionSep 4, 2026Unsealed Device Packaging; Packaging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600331 ↗
• InjurySep 4, 2026Off-Label Use; Device-Device Incompatibility

  It was reported that the atrial pacing lead of a patient dual chamber pacemaker was dislodged requiring surgical intervention to complete a lead revision.A FARAWAVE catheter was selected for use in a FARAPULSE Pulsed Field Ablation (PFA) procedure to treat persistent atrial fibrillation. After performing pulmonary vein isolation and posterior wall isolation in the left atrium, the physician performed a superior vena cava ablation in the right atrium with the catheter is basket shape. As the physician moved down to ablate the cavotricuspid isthmus (CTI) and transitioned the catheter to flower shape, the splines of the FARAWAVE catheter snagged the atrial pacing lead of the patient non-Boston Scientific dual chamber pacemaker. While attempting to get away from the lead, the physician dislodged the lead. While maneuvering the farapulse catheter around the right atrium to perform a CTI line ablation, the physician snagged the patients atrial pacer lead and it was pulled loose of the myocardium. The FARAPULSE PFA procedure was completed as planned with no further issues or complications. The patient was seen later the same day for a surgical lead revision. The patient remained hospitali

  Patient problems: Insufficient Information

  MAUDE report 50600231 ↗
• InjurySep 3, 2026Material Twisted/Bent

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50599638 ↗
• MalfunctionSep 2, 2026Contamination

  It was reported that FARAWAVE Catheter was selected for atrial fibrillation farapulse. It has been mentioned that upon opening the device, a white substance was found on the device's handle. No damage was evident on the packaging. The procedure was completed using different device (same model). No patient complications occurred.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50572687 ↗
• MalfunctionSep 2, 2026Nonstandard Device; Physical Resistance/Sticking

  During an atrial fibrillation ablation, a FARAWAVE Ablation Catheter was selected for use. During preparation, it was noted that the wire had a slight resistance when pulling back into the catheter. After an additional inspection, a small fragmentation was noticed at the distal tip of the catheter. The catheter was replaced and procedure was completed with no patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50565498 ↗

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-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-2753-2026 · 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
• Z-2278-2025 · Jun 25, 2025 · Open, Classified
  FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401