FARAWAVE™ M004PF41M402Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00191506043155), received between Jul 24, 2024 and Sep 25, 2026 — classified as 2 deaths, 16 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (19 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 57 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A PULSE FIELD ABLATION (PFA) PROCEDURE USING A FARAWAVE PFA CATHETER THE PATIENT EXPERIENCED HEMOLYSIS AND WAS HOSPITALIZED.

  Patient problems: Hemolysis

  MAUDE report 25108011 ↗
• MalfunctionMar 30, 2026Entrapment of Device

  IT WAS REPORTED THAT DURING A PULSE FIELD ABLATION (PFA) PROCEDURE USING A FARAWAVE PFA CATHETER THE GUIDEWIRE BECAME STUCK IN THE DEVICE. TOWARDS THE END OF THE PROCEDURE THE PHYSICIAN ATTEMPTED TO RETRACT THE WIRE BUT FOUND THEY WERE UNABLE TO DO SO. AS THE PROCEDURE WAS COMPLETED THE CATHETER AND WIRE WERE REMOVED FROM THE BODY TOGETHER. THE PHYSICIAN HAD TO WRAP THE WIRE AROUND THEIR HAND AND PULL HARD IN ORDER TO REMOVE THE WIRE FROM THE CATHETER. THE DEVICES WERE NOT REPLACED AS THE PROCEDURE WAS DONE. THERE WERE NO PATIENT COMPLICATIONS AND NO TISSUE WAS SEEN AT THE TIP OF THE CATHETER. THE CATHETER IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24710375 ↗
• MalfunctionMar 24, 2026Restricted Flow rate

  IT WAS REPORTED THAT DURING A PROCEDURE USING A FARAWAVE CATHETER, THE CATHETER WOULD NOT FLUSH WITH THE PUMP. NO PATIENT HARM OCCURRED. ANOTHER CATHETER WAS OPENED AND USED TO COMPLETE THE CASE. MDR REPORT: 0700100000-2026-8011.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675060 ↗
• DeathMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT DIED. FOLLOWING A PULSED FIELD ABLATION (PFA) PROCEDURE WHERE A FARAWAVE CATHETER WAS SELECTED FOR USE. THE PATIENT DIED. NO MORE INFORMATION WAS PROVIDED. IT'S UNKNOWN IF THE DEVICE WILL RETURN FOR LABORATORY ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634501 ↗
• MalfunctionMar 18, 2026Material Deformation

  IT WAS REPORTED THAT DURING PREPARATION FOR AN ABLATION PROCEDURE, ONE FARAWAVE CATHETER WAS SELECTED FOR BEING USED WHEN THE FLOWER PETALS WERE DEFLECTED; THEY WERE SHARP, NOT ROUND AND THE PLASTIC LOOKED TO BE STRETCHED AND CRACKING. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS. THE DEVICE IS NOT EXPECTED TO RETURN FOR LABORATORY ANALYSIS SINCE IT WAS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24630999 ↗
• MalfunctionMar 2, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE ATRIAL FIBRILLATION ABLATION FARAWAVE CATHETER WAS SELECTED FOR USE. IT HAS BEEN MENTIONED THAT THE FLUID CONNECTOR WAS LEAKING WHEN CONNECTING TO THE FLUID TUBING. NO PATIENT COMPLICATIONS OCCURRED. THE PROCEDURE WAS COMPLETED USING NEW CATHETER. THE PRODUCT IS NOT EXPECTED TO RETURN AS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489600 ↗
• MalfunctionFeb 24, 2026Entrapment of Device

  IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION ABLATION, A FARAWAVE WAS SELECTED FOR USE. DURING PROCEDURE, ADVANCING THE MERIT ROSEN WIRE WAS DIFFICULT. TROUBLESHOOTING WAS PERFORMED BY CHANGING THE WIRE; HOWEVER, THE ISSUE WAS NOT RESOLVED. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS. THE DEVICE IS EXPECTED TO BE RETURNED FOR LABORATORY ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24426043 ↗
• MalfunctionFeb 13, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT FARAWAVE CATHETER WAS LEAKING FLUID FROM THE END OF THE CATHETER NEAR THE FLUSHING PORT WHICH WAS CRACKED. THE PROCEDURE WAS COMPLETED USING DIFFERENT FARAWAVE CATHETER. NO PATIENT COMPLICATIONS OCCURRED. THE PRODUCT IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332312 ↗
• MalfunctionFeb 6, 2026Contamination; Difficult to Flush

  IT WAS REPORTED THAT DURING PREPARATION FOR THE FARAWAVE PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION, ON THE FIRST CATHETER THE FLUSH PORT DID NOT APPEAR CLEAR. IT HAD A MILKY-WHITE APPEARANCE TO IT. WHEN FLUSHING WAS TRIED IN THE LUMEN THAT HANGS OFF THE HANDLE, NO SALINE WOULD ADVANCE. A SECOND CATHETER WAS USED, AND THIS ONE HAD THE SAME CLOUDY APPEARANCE. THERE ALSO APPEARED TO BE EXTRA GLUE AT THE END OF THE CATHETER AS WELL. FLUSHING THIS CATHETER WAS DIFFICULT AS WELL. THE FIRST TWO CATHETERS HAD THE SAME LOT NUMBER. A THIRD CATHETER WAS OPENED IT ALSO HAD THE SAME APPEARANCE; WITH VISUAL INSPECTION IT APPEARED THE GLUE WAS CRACKING INSIDE THE LUMEN OF THE FLUSH PART WHEN MOVING THE FLEXIBLE PORTION. IT EVEN FELT CRACKLY. AT THIS POINT A PIECE FLAKED OFF WHERE THE PORT ENTERS THE BLUE PORTION OF THE CATHETER. THE FOURTH CATHETER OPENED WAS A FARAWAVE 35MM WITH THE SAME APPEARANCE AND DID NOT FLUSH. A FIFTH CATHETER WAS OPENED WITH THE SAME APPEARANCE OF NOT BEING CLEAR AND IT DID NOT FLUSH EITHER. THIS CATHETER TUBING WAS CUT OPEN FOR INSPECTION, AND IT WAS NOTICED A LONG BEAD OF GLUE STICKING OUT AS THE OUTSIDE EDGES WERE CUT AND PULLED APART. 10 MORE CATHETERS WERE OPENED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24282631 ↗
• MalfunctionFeb 6, 2026Contamination; Difficult to Flush

  IT WAS REPORTED THAT DURING PREPARATION FOR THE FARAWAVE PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION, ON THE FIRST CATHETER THE FLUSH PORT DID NOT APPEAR CLEAR. IT HAD A MILKY-WHITE APPEARANCE TO IT. WHEN FLUSHING WAS TRIED IN THE LUMEN THAT HANGS OFF THE HANDLE, NO SALINE WOULD ADVANCE. A SECOND CATHETER WAS USED, AND THIS ONE HAD THE SAME CLOUDY APPEARANCE. THERE ALSO APPEARED TO BE EXTRA GLUE AT THE END OF THE CATHETER AS WELL. FLUSHING THIS CATHETER WAS DIFFICULT AS WELL. THE FIRST TWO CATHETERS HAD THE SAME LOT NUMBER. A THIRD CATHETER WAS OPENED IT ALSO HAD THE SAME APPEARANCE; WITH VISUAL INSPECTION IT APPEARED THE GLUE WAS CRACKING INSIDE THE LUMEN OF THE FLUSH PART WHEN MOVING THE FLEXIBLE PORTION. IT EVEN FELT CRACKLY. AT THIS POINT A PIECE FLAKED OFF WHERE THE PORT ENTERS THE BLUE PORTION OF THE CATHETER. THE FOURTH CATHETER OPENED WAS A FARAWAVE 35MM WITH THE SAME APPEARANCE AND DID NOT FLUSH. A FIFTH CATHETER WAS OPENED WITH THE SAME APPEARANCE OF NOT BEING CLEAR AND IT DID NOT FLUSH EITHER. THIS CATHETER TUBING WAS CUT OPEN FOR INSPECTION, AND IT WAS NOTICED A LONG BEAD OF GLUE STICKING OUT AS THE OUTSIDE EDGES WERE CUT AND PULLED APART. 10 MORE CATHETERS WERE OPENED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24282623 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  DURING A REDO RADIO FREQUENCY ABLATION, A FARAWAVE CATHETER WAS USED. DURING THE PROCEDURE, IT WAS NOTED THAT THE PATIENT HAD ATRIAL TACHYCARDIA (AT) THAT WAS NOT AMENABLE TO ABLATION, AND THE PATIENT WAS ADMITTED FOR AMIODARONE LOADING. THE PATIENT REVERTED TO ATRIAL FIBRILLATION ON THE EVENING OF (B)(6) 2025 FOLLOWING THE ABLATION. THE PATIENT WAS ADMITTED FOR AMIODARONE LOADING, UNDERWENT AN ADDITIONAL DIRECT CURRENT CARDIOVERSION (DCCV) ON (B)(6) 2025, AND SUCCESSFULLY CONVERTED BACK TO NORMAL SINUS RHYTHM. THE PATIENT LATER RETURNED TO ATRIAL FIBRILLATION BUT REMAINED ASYMPTOMATIC. THE PATIENT WAS DISCHARGED AND CONTINUED ORAL AMIODARONE AT HOME AND IS SCHEDULED FOR ANOTHER CARDIOVERSION AFTER THE THREE MONTH FOLLOW UP PERIOD.

  Patient problems: Atrial Fibrillation

  MAUDE report 24003497 ↗
• MalfunctionDec 31, 2025Fluid/Blood Leak; Nonstandard Device; Difficult or Delayed Activation; Fluid/Blood Leak; Nonstandard Device; Difficult or Delayed Activation

  DURING A PULSED FIELD ABLATION (PFA) PROCEDURE TO TREAT ATRIAL FIBRILLATION, A FARAWAVE CATHETER WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT CATHETER SLIDER WAS DIFFICULT TO MANEUVER. THE PHYSICIAN EXERCISED THE SLIDER KNOB SEVERAL TIMES. THE ISSUE RESOLVED, AND THE CATHETER WAS BROUGHT TO THE TABLE TO BE INSERTED. WHEN HOOKING CATHETER UP TO FLUSH, IT WAS THEN NOTED THAT THE SIDE FLUSH PORT WAS BROKEN AND FLUID LEAKING OUT OF THE SIDE FLUSH PORT. THE CATHETER WAS REPLACED, AND PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23933524 ↗
• MalfunctionDec 26, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DURING THE PULMONARY VEIN ISOLATION PROCEDURE, THE FARAWAVE CATHETER WAS SELECTED FOR USE. IT HAS BEEN REPORTED THAT AFTER INSERTION OF THE STARTER WIRE THE HANDLE ON THE PROXIMAL SIDE DID NOT MOVE WHEN ADJUSTING THE TIP OF THE CATHETER. IT FELT LIKE THE WIRE GOT STUCK. NO PATIENT COMPLICATIONS OCCURRED. THE PROCEDURE WAS COMPLETED USING DIFFERENT FARAWAVE CATHETER. THE PRODUCT WAS RECEIVED FOR ANALYSIS AND INVESTIGATION IS STILL IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23895672 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FARAWAVE CATHETER WAS USED FOR A PULSED FIELD ABLATION. AT THE 6 MONTH FOLLOW UP, THE PATIENT WAS PRESCRIBED A CLASS II ANTIARRHYTHMIC MEDICATION FOR AN ARRHYTHMIA OTHER THAN ATRIAL FIBRILLATION. NO FURTHER DETAILS WERE PROVIDED, BUT THE 12 LEAD ECG DEMONSTRATED SINUS RHYTHM.

  Patient problems: Arrhythmia

  MAUDE report 23865620 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A VENTRICULAR TACHYCARDIA REQUIRING HOSPITALIZATION POST IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SHOCK. NO MORE INFORMATION WAS PROVIDED. NO DEVICE ISSUES WERE REPORTED. IT'S UNKNOWN IF THE DEVICE WILL RETURN FOR LABORATORY ANALYSIS.

  Patient problems: Arrhythmia

  MAUDE report 23858030 ↗
• MalfunctionDec 15, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT DURING A PULSE FIELD ABLATION (PFA) PROCEDURE TO TREAT ATRIAL FIBRILLATION, A FARAWAVE CATHETER WAS SELECTED FOR USE. THE CATHETER WAS UNABLE TO BE FLUSHED THROUGH SIDE FLUSH PORT AS THE FLUSH PORT WAS BLOCKED. CATHETER DRIP NOT FUNCTIONAL. THE ORIGINAL DEVICE WAS USED TO COMPLETE THE PROCEDURE AND NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. IT WAS FURTHER REPORTED THAT THE EVENT WAS DISCOVERED MID-PROCEDURE. THE DOCTOR REMOVED THE CATHETER AFTER ABLATING IN THE LEFT ATRIUM SO THAT THEY COULD CREATE A POST-MAP WITH A MAPPING CATHETER. IT WAS OBSERVED THAT ONE OF THE PULMONARY VEINS WAS STILL CONNECTED, SO THE PHYSICIAN NEEDED TO GO BACK IN WITH THE FARAWAVE CATHETER. WHEN THE PHYSICIAN WENT TO RE-INSERT THE CATHETER, IT WAS NOTICED THAT THE CATHETER WASN'T DRIPPING. THE PHYSICIAN OPENED THE FLUSH, BUT NOTHING WAS COMING OUT. FLUSH PORT WAS BLOCKED. THE REP IS UNSURE IF THIS ISSUE WAS PRESENT UPON OPENING THE PACKAGING. AFTER THE ISSUE WAS DISCOVERED, THE CATHETER WAS REPLACED AND THEY COMPLETED THE PROCEDURE WITH A NEW CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23809688 ↗
• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ST SEGMENT ELEVATION. DURING A PULSE FIELD ABLATION (PFA) PROCEDURE TO TREAT ATRIAL FIBRILLATION A FARAWAVE CATHETER WAS USED. THE FARADRIVE SHEATH AND THE CATHETER WERE INSERTED, BUT PRIOR TO ABLATION AN ST SEGMENT ELEVATION WAS OBSERVED ON THE I, II, AND AVF LEADS. THE ST SEGMENT ELEVATION RESOLVED AFTER TWO TO THREE MINUTES WITH NO MEDICAL INTERVENTION NEEDED. THE PROCEDURE WAS ABLE TO BE COMPLETED AFTERWARDS. THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS DUE TO DISPOSAL.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 23714747 ↗
• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ARRHYTHMIA, MYOCARDIAL INFARCTION, ISCHEMIA, ST SEGMENT ELEVATION, CARDIAC ARREST, HEART BLOCK AND VASOSPASM. IT WAS REPORTED THAT FARAWAVE WAS SELECTED FOR USE DURING A AF ABLATION. PRIOR TO PROCEDURE START PATIENT WAS HAVING TO BE HEMODYNAMICALLY SUPPORTED DUE TO HYPOTENSION (EF 35-40%). UNDERWENT PROCEDURE AT PHYSICIANS' DISCRETION. ABLATED LEFT SUPERIOR PULMONARY VEIN (LSPV), LEFT INFERIOR PULMONARY VEIN (LIPV), RIGHT SUPERIOR PULMONARY VEIN (RSPV) FOLLOWING OPTIWAVE WORKFLOW. RIGHT INFERIOR PULMONARY VEIN (RIPV) WAS ENGAGED AND FOUR FLOWERS WERE DONE, PHYSICIAN WAS MOVING INTO BASKET TO FINISH THE LAST FOUR LESIONS. AT THE TIME OF THE FOURTH FLOWER, PHYSICIAN NOTICED ST SEGMENT ELEVATION IN INFERIOR LEADS AND HEART RATE INCREASE. RULED OUT AIR EMBOLI WITH ANGIOGRAPHY. INTERVENTIONAL CARDIOLOGY (IC) PAGED AND STARTED LEFT HEART CATHETERIZATION (LHC). DURING LHC, PATIENT WENT INTO PULSELESS ELECTRICAL ACTIVITY (PEA) AND COMPRESSIONS WERE STARTED FOLLOWING ACLS PROTOCOLS ALONG WITH PHARMACOLOGICAL INTERVENTIONS. LHC RESUMED, PAUSED COMPRESSIONS TO GET A CONTRAST SHOT OF THE RIGHT CORONARY ARTERY (RCA), CONFIRMED RCA VASOSPASM. PATIENT

  Patient problems: Arrhythmia; Cardiac Arrest; Heart Block; Ischemia; Low Blood Pressure/ Hypotension; Myocardial Infarction; Non specific EKG/ECG Changes; Vasoconstriction; Ventricular Fibrillation

  MAUDE report 23488314 ↗
• MalfunctionNov 5, 2025Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  IT WAS REPORTED THAT DURING PREPARATION FOR A FARAPULSE PROCEDURE TO TREAT PAROXYSMAL ATRIAL FIBRILLATION, VISIBLE AIR WAS OBSERVED IN THE FLUSH PORT OF A FARAWAVE 35MM. A FLUID LEAK WAS ALSO OBSERVED AT THE FLUSH PORT. ATTEMPTS WERE MADE TO REMOVE THE AIR USING A 20CC SYRINGE WITH NO RESOLUTION. A GUIDEWIRE WAS USED TO ATTEMPT TO DISLODGE THE BUBBLE, BUT THIS WAS UNSUCCESSFUL AS WELL. FINALLY, THE CATHETER WAS REPLACED WITH A SIMILAR DEVICE, AND THE PROCEDURE WAS ABLE TO BE COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE WAS DISPOSED AND IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23477815 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ST SEGMENT ELEVATION OCCURRED. A PULSE FIELD ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WAS PERFORMED USING A 31MM FARAWAVE CATHETER. FOLLOWING PULSE FIELD ABLATION OF THE LEFT SUPERIOR PULMONARY VEIN ST SEGMENT ELEVATION WAS IDENTIFIED VIA SEVERAL ELECTROCARDIOGRAM CHANNELS. NO INTERVENTIONS WERE PROVIDED AND THE ST SEGMENT ELEVATION RESOLVED AFTER APPROXIMATELY TWO (2) TO THREE (3) MINUTES. BASELINE RHYTHM WAS REESTABLISHED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 23291564 ↗
• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED HYPOTENSION AND A PERICARDIAL EFFUSION. DURING A PULSED FIELD ABLATION (PFA) PROCEDURE A FARAWAVE WAS SELECTED FOR USE. AFTER THE PROCEDURE WAS COMPLETED, IT WAS NOTICED THAT THE PATIENT'S BLOOD PRESSURED DROPPED. THE PHYSICIAN CHECKED THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND NOTICED A PERICARDIAL EFFUSION. THE PATIENT WAS TAKEN TO THE OPERATION ROOM TO PERFORM A PERICARDIAL WINDOW. THE PATIENT RECOVERED SUCCESSFULLY FROM THE EVENT. IT WAS FURTHER REPORTED THAT NO ISSUES WERE FOUND MOVING THE GUIDEWIRE DURING THE PROCEDURE. EFFUSION WAS DISCOVERED POST-PROCEDURE AND THE PERICARDIOCENTESIS SOLVED THE ISSUE. PATIENT HAD RECOVERED AND WAS DISCHARGED SUCCESSFULLY.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 22751802 ↗
• MalfunctionJul 8, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHILE OPENING A FARAWAVE CATHETER THE IRRIGATION PORT SHOWS CLOUDY AND SUSPECTED CONTAMINATION. THE CATHETER WAS OPENED BUT NOT USED THEREFORE, NO PATIENT INVOLVEMENT. REPLACEMENT WAS REQUESTED. IT IS UNKNOWN IF THE DEVICE IS GOING TO BE RETURNED FOR LABORATORY ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22438531 ↗
• MalfunctionJun 27, 2025Entrapment of Device; Off-Label Use; Entrapment of Device; Off-Label Use

  IT WAS REPORTED THAT DURING A PULSED FIELD ABLATION (PFA) PROCEDURE TO TREAT A PERSISTENT ATRIAL FIBRILLATION A FARAWAVE WAS SELECTED FOR USE. WHEN THE PHYSICIAN WAS WORKING ON THE RIGHT SIDED VEINS NOTICED THAT THE WIRE BECAME STUCK AND THE CATHETER AND COULD NOT BE ADVANCED OR RETRACTED. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS EXPECTED TO RETURN FOR LABORATORY ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22351515 ↗
• InjuryJun 26, 2025Material Twisted/Bent; Positioning Problem; Material Twisted/Bent; Positioning Problem

  IT WAS REPORTED THAT THE CATHETER WAS DIFFICULT TO POSITION AT THE LEFT PULMONARY VEINS AND EXHIBITED A SPLINE INVERSION, AND THE PATIENT EXPERIENCED PERICARDIAL EFFUSION AND HYPOTENSION. DURING A PULSE FIELD ABLATION (PFA) PROCEDURE A FARAWAVE CATHETER WAS USED. DURING TRANSEPTAL PUNCTURE (TSP), THE VERSACROSS WIRE KEPT SLIDING POSTERIOR. THE PHYSICIAN REPOSITIONED A FEW TIMES AND THEN DECIDED TO USE A POSTERIOR STICK. THE PHYSICIAN WAS UNABLE TO ADVANCE THE FARADRIVE SHEATH ACROSS THE SEPTUM, SO THE VERSACROSS WIRE WAS PULLED BACK TO REPOSITION AND GO TRANSSEPTAL AGAIN. DURING THE REPOSITIONING, THE SCRUB TECH PUSHED THE FOOT PEDAL FOR RADIO FREQUENCY DELIVERY FOR TRANSSEPTAL. IT WAS UNCONFIRMED WHERE THE WIRE WAS POSITIONED AT THIS TIME. BUBBLES WERE NOTED IN THE LEFT ATRIUM (LA) AND THE WIRE WAS ADVANCED INTO THE LEFT ATRIUM (LA). THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER WAS ADVANCED TO THE LA, AND THEN THE FARARDRIVE SHEATH WAS ADVANCED THERE WITH THE FARAWAVE CATHETER INSIDE. THE PHYSICIAN FELT IT WAS TOO TIGHT TO MOVE THE SHEATH, SO THE ICE CATHETER WAS REMOVED FROM THE LA AND POSITIONED IN THE RIGHT ATRIUM (RA). THE FARAWAVE CATHETER WAS THEN ADVANCED TO THE LEFT PU

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 22333958 ↗

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