FARAWAVE™ NAV M004PF41M412Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00191506043209), received between Oct 9, 2025 and Sep 17, 2026 — classified as 7 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Packaging Problem” (5 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 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. Emergency 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; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 50805557 ↗
• MalfunctionSep 10, 2026Unsealed Device Packaging; Packaging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50724456 ↗
• MalfunctionSep 10, 2026Unsealed Device Packaging; Packaging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50724454 ↗
• MalfunctionSep 10, 2026Unsealed Device Packaging; Packaging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50724032 ↗
• MalfunctionSep 10, 2026Unsealed Device Packaging; Packaging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50724023 ↗
• InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that hemoglobinuria occurred.An ablation procedure was performed using FARAWAVE NAV catheter. A urinalysis was positive for blood in the urine, and the patient was diagnosed with hemoglobinuria. No further information on the status of the patient is available.

  Patient problems: Hemolysis

  MAUDE report 50408019 ↗
• InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem

  It has been reported that bradycardia, pericardial effusion and cardiac tamponade occurred post procedure 3hrs later. FARAWAVE was selected for use and during a transesophageal echocardiogram (TTE), a pericardial effusion was noted. Patient was brought back into the room to get a Pericardiocentesis. Pigtail versacross was used in the procedure. The patient has been discharged. The device is not expected to be returning as it has been disposed.

  Patient problems: Bradycardia; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 50374581 ↗
• MalfunctionAug 3, 2026Entrapment of Device

  It was reported that Catheter Guidewire Stuck occurred.It was reported that a FARAWAVE catheter was selected to treat a paroxysmal atrial fibrillation (PAF). During procedure, when the catheter was in the left atrium (LA) and while advancing the guidewire into the right inferior pulmonary vein (RIPV), the guidewire was unable to be retracted. The physician undeployed the catheter into the sheath and unfortunately pulled the tissue that was stuck into the guidewire. Troubleshooting was performed; it was attempted to advance the guidewire slightly and then retract it, but it did not work. A non-Boston Scientific guidewire was used. The catheter has been received at Boston Scientific's Post Market laboratory where it is awaiting analysis. It was informed that there were no issues with the guidewire prior to insertion and no catheter malfunctions were present. Also, no deployment issues were reported.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50113632 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced stomach discomfort and vomited once after the procedure.After a pulse field ablation (PFA) procedure using a FARAWAVE catheter the patient experienced stomach discomfort and vomited gastric contents once. The patient was administered medication which resolved the complications.

  Patient problems: Discomfort; Vomiting

  MAUDE report 25048013 ↗
• MalfunctionMar 18, 2026Difficult to Remove; Blocked Connection; Difficult to Advance

  IT WAS REPORTED THAT, FOR THE FARAWAVE PROCEDURE FOR ATRIAL FIBRILLATION, THE DEVICE WAS PREPPED AND TESTED ON BACK TABLE WITH NO ISSUES. THE DEVICE INSERTED INTO LEFT ATRIUM (LA) BY THE PHYSICIAN. THE WIRE ADVANCED INTO LEFT SUPERIOR PULMONARY VEIN (LSPV) AND THE CATHETER FUNCTIONED PROPERLY DURING DELIVERY OF FLOWER AND BASKET PULSES. WHEN ATTEMPTING TO ADVANCE WIRE INTO THE LSPV, THE PATIENT EXPERIENCED INCREASED RESISTANCE. VISUALIZING THE WIRE AND FLOWER ON ICE, HE CONTINUED TO ATTEMPT TO ADVANCE AND RETRACT THE WIRE. HE STILL NOTED AN UNUSUAL AMOUNT OF RESISTANCE. HE STATED, "SOMETHING ISN'T RIGHT WITH THIS CATHETER." SO, HE REMOVED THE CATHETER FROM THE BODY. THE GUIDEWIRE RESISTANCE WAS SO MUCH THAT HE COULD ACTUALLY HOLD THE ENTIRE CATHETER UP WHILE GRASPING NOTHING BUT THE WIRE. THE SCRUB TECH ATTEMPTED TO DEPLOY THE CATHETER INTO BASKET (WITH THE WIRE OUT THE DISTAL TIP), AND THE GUIDEWIRE LUMEN BENT. WE REPLACED WITH ANOTHER 35MM CATHETER AND FINISHED THE PROCEDURE WITH NO OTHER ISSUES. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE WAS RECEIVED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634514 ↗
• MalfunctionFeb 23, 2026Fluid/Blood Leak; Nonstandard Device; Material Twisted/Bent

  IT WAS REPORTED THAT SPLINE BUNCHING AND EXCESSIVE FLUID STREAM WAS SEEN DURING ENERGY DELIVERY. PHYSICIAN REFUSED TO RESHEATH AND SPIN CATHETER TO FREE BUNCHING AND 301 ERROR OCCURRED OCCASIONALLY ON GENERATOR BUT IT WAS FIXED WITH REPOSITIONING OF CATHETER. PHYSICIAN WAS AGAIN ADVISED TO RESHEATH CATHETER TO FREE UP THE BUNCHING BUT REFUSED AND REPLACED THE CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING DIFFERENT DEVICE (SAME MODEL). NO PATIENT COMPLICATIONS OCCURRED. THE PRODUCT IS EXPECTED TO RETURN FOR ANALYSIS. IT WAS FURTHER CLARIFIED THAT NO LEAK SEEN FROM THE CATHETER. TURBULENCE APPEARED AT TIP OF CATHETER DURING ABLATION, THE SPLINES WERE INVERTED ON TOP OF EACH OTHER AND UNABLE TO SEPARATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24416534 ↗
• MalfunctionDec 22, 2025Contamination; Failure to Deliver Energy; Off-Label Use; Packaging Problem; Contamination; Failure to Deliver Energy; Off-Label Use; Packaging Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE ONE FARAWAVE CATHETER WAS SELECTED FOR BEING USED, CATHETER INITIALLY WORKED AND DELIVERED SIX APPLICATIONS. MIDWAY THROUGH THE PROCEDURE, ENERGY DELIVERY STOPPED WITHOUT ANY OPAL ERROR MESSAGE. REPLACING THE CATHETER RESOLVED THE ISSUE. UPON INSPECTION, THE ORIGINAL CATHETER HAD UNUSUAL WHITE MARKINGS ON ITS HANDLE, THOUGH PACKAGING WAS STERILE AND NOT EXPIRED. IT WAS ALSO INDICATED THAT THE PACKAGING WAS DAMAGED. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS NOT EXPECTED TO RETURN FOR LABORATORY ANALYSIS SINCE IT WAS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23873582 ↗
• InjuryNov 20, 2025Nonstandard Device; Material Twisted/Bent; Nonstandard Device; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. DURING A PULSE FIELD ABLATION (PFA) PROCEDURE TO TREAT PAROXYSMAL ATRIAL FIBRILLATION A FARAWAVE NAV CATHETER WAS USED. ACCESS WAS GAINED WITHOUT ISSUE. A PRE-EFFUSION CHECK WAS PERFORMED WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE) WHICH SHOWED A SMALL EFFUSION WHICH THE PHYSICIAN NOTED. THE TRANSSEPTAL PUNCTURE WAS PERFORMED WITH THE STICK APPEARING TO BE POINTING AT THE RIDGE POSTERIOR TO THE LEFT ATRIAL APPENDAGE (LAA) AND MID-LEVEL ON THE SEPTUM. THERE WAS SOME DIFFICULTY GETTING THE SHEATH ACROSS THE SEPTUM AND PLACING THE CORONARY SINUS CATHETER. THE DIFFICULTY WAS ATTRIBUTED TO THE NATURE OF THE PATIENT'S SEPTUM BEING FAIRLY FIBROTIC. THE CATHETER WAS INSERTED AND USED FOR MAPPING AND ABLATION WORKFLOW. THE LEFT VEINS WERE ISOLATED WITH NO APPARENT ISSUES. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO WIRE THE RIGHT INFERIOR PULMONARY VEIN (RIPV) AND DELIVER ABLATIONS IN THE BASKET SHAPE. IT WAS NOTICED THAT RESISTANCE WAS FELT MANEUVERING THE GUIDEWIRE, SPECIFICALLY IN THE RIPV. SOME BUNCHING ERRORS (ERROR 301 PRE-PULSE FAILURE AND 303 ARC DETECT FAILURE) WERE NOTED ALONG WITH A LACK OF COAXIAL PLACEMENT, SO AB

  Patient problems: Pericardial Effusion

  MAUDE report 23606581 ↗
• InjuryNov 19, 2025Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT A PATIENT EXPERIENCED ASYSTOLE. WHILE PERFORMING A FARAWAVE NAV CASE ON A PATIENT, THE PATIENT WAS TREATED FOR ATRIAL FIBRILLATION AND A RIGHT SIDED CAVO-TRICUSPID ISTHMUS (CTI) LINE WITH A FARAWAVE NAV CATHETER WAS PERFORMED PRIOR TO CROSSING OVER INTO LEFT ATRIUM, WHICH CTI ABLATION IS CONSIDERED OFF LABEL USE OF THE FARAWAVE CATHETER. FOUR PFA DELIVERIES OCCURRED IN THE RIGHT ATRIUM FOR CTI LINE FOR FLUTTER THEN 2 DELIVERIES OCCURRED IN THE LEFT SUPERIOR PULMONARY VEIN (LSPV) IN FLOWER DEPLOYMENT CONFIGURATION. AT THIS POINT, THE PATIENT WENT ASYSTOLE AND CHEST COMPRESSIONS WERE PERFORMED AND EPINEPHRINE (CAUSED PATIENT BLOOD PRESSURE TO ELEVATE) AND THEN NITRO WAS ADMINISTERED (CAUSING PATIENT TO BOTTOM OUT PRESSURE-WISE). THE CODE LASTED 15-20 SECONDS. IT IS SUSPECTED THAT THE PHYSICIAN HIT A GANGLIONATED PLEXI, WHICH CAUSED PATIENT TO VAGAL DOWN AND GO ASYSTOLE FOR THE 15-20 SECONDS. RHYTHM RECOVERED AFTER THIS PERIOD. THE PHYSICIAN WAS CONCERNED FOR A POSSIBLE EFFUSION AND BROUGHT THE PATIENT IN ECHO AND IT WAS CONFIRMED THERE WAS NO EFFUSION. SINCE THE PATIENT BLOOD PRESSURE WAS UNSTABLE, THERAPY WAS ABORTED AT THAT TIME. THE PATIENT WAS IN STABLE CONDI

  Patient problems: Asystole; Low Blood Pressure/ Hypotension; Syncope/Fainting

  MAUDE report 23594512 ↗
• MalfunctionNov 10, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT DURING PREPARATION FOR A PULSE FIELD ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION, A FARAWAVE NAV CATHETER WAS SELECTED FOR USE. IT WAS NOTED THAT THE FLUSH PORT WAS WARPED. THIS DAMAGE WAS NOTICED UPON OPENING THE DEVICE PACKAGING. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT COMPLICATIONS. THE CATHETER IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23515746 ↗
• InjuryOct 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED PERICARDIAL EFFUSION. DURING A PULSED FIELD ABLATION (PFA) PROCEDURE TO TREAT ATRIAL FIBRILLATION (AF) A FARAWAVE CATHETER WAS SELECTED FOR USE. THE PHYSICIAN STRUGGLED TO GET INTO THE RIGHT PULMONARY VEINS. THE PHYSICIAN WITHDREW THE SHEATH AND TRIED TO DO ANOTHER TRANSEPTAL BUT WAS HAVING COMPLICATIONS. IN THE END, THE PHYSICIAN TRIED AGAIN WITH THE FARADRIVE SHEATH AND MANAGED TO ABLATE WITH THE CATHETER ON THE RIGHT SIDE. AFTER WITHDRAWING THE SHEATH OUT OF LEFT ATRIUM, A SMALL PERICARDIAL EFFUSION WAS SEEN. THE ABLATION HAD BEEN TAKING PLACE FOR FOUR HOURS WHEN THE COMPLICATION WAS OBSERVED AND OCCURRED AFTER THE FARAWAVE CATHETER WAS PULLED OUT OF THE LEFT ATRIUM. AFTER 20 MINUTES, THE PATIENT BLOOD PRESSURE DROPPED TO 70MMHG AND THE PHYSICIAN DECIDED TO DRAIN THE BLOOD. A DRAINAGE WAS LEFT IN THE PATIENT. THE PATIENT IS EXPECTED TO FULLY RECOVER FROM THE EVENT. THE PATIENT HOSPITAL STAY WAS EXTENDED IN RESPONSE TO THE COMPLICATION. THE DEVICE IS NOT EXPECTED TO RETURN AS IT WAS DISPOSED.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 23255565 ↗

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