FARASTARRecalls & reported problems across all models

We found 6 models of FARASTAR by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 38 adverse event reports in the FDA's MAUDE database, received between Nov 14, 2024 and Sep 25, 2026 — classified as 2 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Contamination” (10 reports).

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

Most reported FARASTAR problems

FARASTAR models

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

• FARASTAR™ M004PF41M434

  Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
  13 reports
• FARASTAR™ M004PF61M401

  Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
  10 reports
• FARASTAR™ M004PF61M402

  Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
  6 reports
• FARASTAR™ M004PF41M444

  Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
  5 reports
• FARASTAR™ M004PF61M415

  Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
  2 reports
• FARASTAR™ M004PF61M601

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

Recent FARASTAR adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Nonstandard Device

  It was reported that the Procedure Cancelled occurred.It was reported that a FARASTAR generator was selected. During procedure, an error 301 was displayed when it was attempted to deliver pulse field ablation (PFA). No mapping system module (MSM) was being used. Troubleshooting was performed, it was attempted to restart the device, change catheter and catheter cable, but the issue persisted. The procedure was not completed due to this issue. There was no patient complication reported. A field service engineer arrived on site, and the reported issue was confirmed. The unit was powered off and disassembled and removed faulty High Voltage (HV) Master board and installed new one in accordance. The unit was powered on and input new calibration measurements. Functional checks were performed and the unit passed all checks, and it was confirmed that is ready for clinical use. Product return is expected.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896591 ↗
• MalfunctionJun 23, 2026Nonstandard Device

  IT WAS REPORTED THAT DURING A PULMONARY VEIN ISOLATION PROCEDURE A FARASTAR GENERATOR WAS SELECTED FOR USE. DURING THE PROCEDURE, THERE WAS A GENERATOR WAS FOUND TO BE DEFECTIVE AND STOPPED WORKING. THE PROCEDURE HAD TO BE CANCELLED DUE TO THIS EVENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25602332 ↗
• MalfunctionJun 9, 2026Nonstandard Device; Power Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE PERFORMING ABLATION AT THE LIPV USING THE FARAWAVE CATHETER, ERROR CODE 322 APPEARED ON THE FARASTAR TOUCHSCREEN AFTER PRESSING THE DELIVER BUTTON; DESPITE REPEATING THE PREPARE > CONFIRM > DELIVER WORKFLOW AND FOLLOWING TROUBLESHOOTING STEPS, THE ERROR PERSISTED, AND AFTER RESTARTING THE FARASTAR GENERATOR, ERROR CODE 201 WAS DISPLAYED DURING THE STARTUP SELF-TEST. AS A RESULT, THE PROCEDURE HAD TO BE CANCELLED AND COULD NOT BE CONTINUED. NO FURTHER INFORMATION WAS PROVIDED. THERE IS NOT ANY INDICATION IF THE DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25446819 ↗
• MalfunctionMay 29, 2026Nonstandard Device

  It was reported that during a Pulse Field Ablation (PFA) procedure, a FARASTAR Gen 2 Connection Cable was selected for use; however, the case had to be aborted due to a physically damaged cable. No patient complications reported. The account requires a replacement cable.It was informed that the patient was under General Anesthesia, and there were not patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334478 ↗
• MalfunctionMay 22, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT THE REPRESENTATIVE CONTACTED THE TEAM WHILE THE PATIENT WAS ON THE TABLE DUE TO ECG NOISE OBSERVED IN NON-BSC DEVICES WHILE USING THE FARASTAR RSM CABLE. CONNECTIONS AND ECG/EGM SIGNALS WERE PROMPTLY REVIEWED. THE TEAM HAD PREVIOUSLY REPLACED THE RA LEAD ON THE RSM CABLE, WHICH PROVIDED PARTIAL IMPROVEMENT. THE PATIENT HAD INITIALLY BEEN CONSIDERED FOR A STUDY REQUIRING HIGH-QUALITY ECG SIGNALS; HOWEVER, DURING THE CALL, THE PATIENT WAS ORIGINALLY BEING CONSIDERED FOR A STUDY THAT NEEDED GOOD ECGS, DURING THE CALL THE PATIENT WAS RULED OUT FOR THE STUDY. THIS EVENT IS BEING REPORTED FOR A CANCELED/ABORTED PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25260037 ↗
• MalfunctionMay 21, 2026Delivered as Unsterile Product; Difficult to Open or Remove Packaging Material

  DURING PREPARATION FOR A PULSE FIELD ABLATION PROCEDURE, A FARASTAR CATHETER CONNECTION CABLE WAS SELECTED FOR USE. THE PACKAGE WAS DIFFICULT TO OPEN, AND WHILE ATTEMPTING TO REMOVE THE CABLE, ONE END FLIPPED OUT OF THE PACKAGING AND CONTACTED A NON-STERILE SURFACE. THE DEVICE WAS CONSIDERED CONTAMINATED AND WAS REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT INJURY OR COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243998 ↗
• MalfunctionMay 21, 2026Delivered as Unsterile Product; Difficult to Open or Remove Packaging Material

  During preparation for a Pulse Field Ablation procedure, a FARASTAR Catheter Connection Cable was selected for use. The package was difficult to open, and while attempting to remove the cable, one end flipped out of the packaging and contacted a non-sterile surface. The device was considered contaminated and was replaced. The procedure was completed successfully with no patient injury or complications.It was further reported that the event occurred prior to the patient's arrival in the procedure room. The device was disposed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243967 ↗
• MalfunctionMay 14, 2026Nonstandard Device

  IT WAS REPORTED THAT A PROCEDURE WAS CANCELLED. IT WAS REPORTED THAT DURING PREPARATION FOR A PULSED FIELD ABLATION (PFA) PROCEDURE A FARASTAR RSM ECG TRUNK CABLE - AAMI WAS SELECTED FOR USE. HOWEVER, THE CABLE WENT OUT AND A NOISE WAS OBSERVED. THE PROCEDURE WAS CANCELLED DUE TO THIS ISSUE. 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 25167790 ↗
• MalfunctionMay 11, 2026Electrical /Electronic Property Problem; Nonstandard Device; Power Problem

  IT WAS REPORTED THAT DURING A FARAPULSE PROCEDURE, A SERIES OF ERRORS ON THE FARASTAR GENERATOR SYSTEM WERE EXPERIENCED LEADING TO A CANCELLATION OF THE PROCEDURE. FIRST A 305: VOLTAGE FAILURE MESSAGE WAS RECEIVED INDICATING THE MAIN CAPACITORS ARE NOT ABLE TO REACH REQUIRED VOLTAGE WHEN A TREATMENT IS ATTEMPTED. THE CHARGE WAS CANCELLED AND THE SYSTEM WAS RECHARGED, BUT THE MESSAGE REAPPEARED. THE SAME PROCESS WAS REPEATED, RESULTING IN A 322: POWER SUPPLY CHARGE ERROR MESSAGE INDICATING THE POWER SUPPLY IS UNABLE TO CHARGE THE MAIN CAPACITORS IN A GIVEN AMOUNT OF TIME. THE GENERATOR WAS POWER CYCLED, AND A 201: MAIN POST FAILURE MESSAGE APPEARED INDICATING A FAILED POWER ON SELF-TEST. AT THIS POINT, THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED. A FIELD SERVICE ENGINEER ARRIVED ON SITE AND VERIFIED THE REPORTED ISSUE AND ROOT CAUSE. THE FARASTAR HV POWER PRLN PCBA WAS REPLACED WITH A NEW PART PER INTERNAL WORK INSTRUCTIONS. THE SYSTEM PASSED ALL FUNCTIONAL TESTS IS NOW FULLY OPERATIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25142436 ↗
• MalfunctionMar 23, 2026Device Sensing Problem; Material Deformation

  IT WAS REPORTED THAT FARASTAR MSM NAM WAS SELECTED FOR USE. IT HAS BEEN MENTIONED THAT THE FIRST ISSUE WAS MAP SHIFTING WITHOUT PATIENT MOVEMENT. TRIED TO ADJUST THE MAGNET PHYSICALLY TO LINE UP THE MAP YET NO IMPROVEMENT. SECOND ISSUE WAS THAT WHILE ABLATING, CATHETER STARTED TO DISAPPEAR ON THE SCREEN AFTER ABOUT 50-60 ABLATIONS. MAP SHIFT ISSUE OCCURRED AGAIN. USING AN EXTERNAL REFERENCE AND IT WAS ROUTED THROUGH THE RSM. DURING ONE OF THE CASES DURING THE PROCEDURE, A LAB STAFF MEMBER PLACED THE BAYLIS GENERATOR ON TOP OF THE MSM. NO ERRORS OCCURRED ON THE OPAL SYSTEM. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED. THE PROCEDURE WAS CANCELLED. THE PRODUCT IS NOT EXPECTED TO BE RETURNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663016 ↗
• MalfunctionFeb 18, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT DURING A PULSED FIELD ABLATION (PFA) PROCEDURE A FARASTAR PFA GENERATOR WAS SELECTED FOR USE. IT WAS MENTIONED THAT A NOISE ISSUE OCCURRED. THE ISSUE COULD NOT BE SOLVED, SO THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THE PATIENT WAS ALREADY SEDATED WHEN THE PROCEDURE WAS CANCELLED. THE DEVICE IS NOT EXPECTED TO RETURN AS IT REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24383533 ↗
• MalfunctionJan 6, 2026Contamination; Unsealed Device Packaging; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT WHEN OPENING THE PACKAGING FOR A FARASTAR GEN 2 CONNECTION CABLE, THE PACKAGE RIPPED DOWN THE MIDDLE AND CONTAMINATED THE CABLE, WITH NO REPORTED FAULT TO THE PERSON OPENING THE PACKAGING. AT THE TIME OF THE EVENT THERE WAS NO PATIENT PRESENT. THE DEVICE IS NOT EXPECTED TO BE RETURNED AS IT WAS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23981066 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; No Pacing; Adverse Event Without Identified Device or Use Problem; No Pacing

  IT WAS REPORTED THAT A PERFORATION, PERICARDIAL EFFUSION, CARDIAC TAMPONADE AND VENTRICULAR TACHYCARDIA OCCURRED. THE PROCEDURE WAS CANCELLED. DURING A A FLUOROLESS CONCOMITANT ATRIAL FIBRILLATION ABLATION AND LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A FARASTAR PFA SYSTEM WAS SELECTED FOR USE. THE PHYSICIAN OBTAINED ACCESS AND PLACEMENT OF THE CS CATHETER AND MAPPING (WITH A NON-BOSTON SCIENTIFIC) OF THE RIGHT ATRIUM OCCURRED. THE TRANSSEPTAL PUNCTURE (TSP) WAS PERFORMED USING VERSACROSS AND FARADRIVE SHEATH. TRANSEPTAL WAS UNREMARKABLE AND MID MID/ANTERIOR, THE VERSACROSS WIRE WENT INTO THE LEFT ATRIUM AND LEFT ATRIUM APENDAGE. THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER WAS THEN PLACED IN THE LEFT ATRIUM (LA) AND VERSACROSS DILATOR AND WIRE WERE REMOVED AND REPLACED WITH DEVICE TO MAP THE LEFT ATRIUM. THE MAPPING WAS EXCHANGED FOR THE FARAWAVE CATHETER. FOUR FLOWER APPLICATIONS WERE APPLIED WHEN THE PATIENTS HEART RATE AND BLOOD PRESSURE (BP) SOFTENED. ATTEMPTS TO PACE THE PATIENT'S HEART WERE UNSUCCESSFUL DUE TO BOSTON-SCIENTIFIC CAPITAL EQUIPMENT FAILURE (MECHANICAL ISSUE WITH EITHER THE PACING SYSTEM OR THE CARTO MAPPING SYSTEM WASN'T OPEN TO ALLOW PACING AND NO OT

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

  MAUDE report 23927695 ↗
• MalfunctionDec 23, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT FOLLOWING A PULSE FIELD ABLATION (PFA) PROCEDURE USING A FARASTAR PULSE FIELD ABLATION GENERATOR THE PATIENT'S PACEMAKER WAS NO LONGER RESPONSIVE. PRIOR TO THE PROCEDURE THE PATIENT'S IMPLANTABLE CARDIAC DEFIBRILLATOR WAS PROGRAMED TO DISABLE TACHYCARDIA THERAPY AND WAS DOUBLE CHECKED TO ENSURE IT WOULD NOT RESPOND DURING THE PROCEDURE. ABLATIONS WERE PERFORMED IN THE LEFT ATRIUM AND ALONG THE CTI. AFTER THE ABLATION PROCEDURE WAS COMPLETED, THE NURSE ATTEMPTED TO INTERROGATE THE PATIENT'S ICD BUT WAS UNABLE TO DO SO. IT WAS DISCOVERED THAT THE PATIENT'S ICD WAS NO LONGER FUNCTIONING PROPERLY AND THE PATIENT WAS LEFT UNPROTECTED. THE PATIENT UNDERWENT SURGERY LATER THAT DAY TO REPLACE THEIR ICD AND WAS HOSPITALIZED. THE PATIENT HAS RECOVERED WITHOUT FURTHER REPORTED COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23885338 ↗
• MalfunctionNov 25, 2025Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT A FARASTAR CATHETER CABLE WAS SELECTED FOR USE. IT WAS MENTIONED THAT DURING THE PREPARATION THE PACKAGE OF THE DEVICE WAS OPEN BEFORE USE DUE TO UNKNOWN REASON. THUS, THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATION WAS REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURN AS IT WAS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23651553 ↗

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