FARAWAVERecalls & reported problems across all models

We found 4 models of FARAWAVE by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 1,846 adverse event reports in the FDA's MAUDE database, received between Apr 25, 2024 and Sep 30, 2026 — classified as 52 deaths, 621 injuries, 1,173 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (446 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

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

FARAWAVE recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 FARAWAVE problems

FARAWAVE models

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

• FARAWAVE™ M004PF41M401

  Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
  1 recall39 deaths1,515 reports
• FARAWAVE™ M004PF41M431

  Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
  11 deaths272 reports
• FARAWAVE™ M004PF41M402

  Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
  2 deaths57 reports
• FARAWAVE™ M004PF41M432

  Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
  2 reports

Recent FARAWAVE adverse event reports

The 15 most recent reports across all models, 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 ↗
• DeathSep 25, 2026Adverse Event Without Identified Device or Use Problem

  During a Posterior Wall Isolation and Pulmonary Vein Isolation procedure for the treatment of an atrial fibrillation, a Farawave catheter was selected. During procedure, the physician went transeptal with a BRK needle and mapped with a Non-Boston scientific catheter through a Non-Boston scientific sheath. Then exchanged for a Faradrive and used a non- nav Farawave 35 mm to ablate. Catheter details are unknown but there were no issues with deployment or the catheter itself. The ablation proceeded normally and the physician found no effusion at the end. There were no notable changes in vital signs during the case. Standard aspirations and flushes were done. This physician has asked for no guidance, and field specialist was just watching his aspirations and flushes to monitor the sheath. The case concluded and the lab manager reached out around 4 hours later to inform that the patient has coded several times and may not survive. Afterward, it was reported that the patient died after experiencing a myocardial infarction following the procedure.

  Patient problems: Cardiac Arrest; Myocardial Infarction

  MAUDE report 50899581 ↗
• 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 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 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 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hemothorax; Tachycardia

  MAUDE report 50828934 ↗
• 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 ↗

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