FARASTAR™ M004PF61M401Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00191506042882), received between Nov 14, 2024 and Sep 25, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Defective Device” (4 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 10 most recent of 10 reports, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionOct 16, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING A PULSE FIELD ABLATION PROCEDURE WITH A FARASTAR CONSOLE THE MONITOR WAS BLANK, BUT HAS SOME FUNCTIONALITY, THE UNIT WAS REBOOTED, BUT THE ISSUE PERSISTED. THE CABLE CONNECTION WAS CHECKED, BACK/UNDER MONITOR AND ALL WAS SECURE AND CABLES LOOK PHYSICALLY FINE. BAD MONITOR OR VIDEO CARD IS SUSPECTED. SYSTEM MONITOR WENT BLANK DURING USE. SEVERAL RESTARTS WERE DONE BUT THE VIDEO WOULD NOT RETURN. THE CASE WAS ABORTED. THE PRODUCT IS RETURNED FOR LABORATORY ANALYSIS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23310870 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED SUPPRESSION AND SUSPECTED PERICARDITIS. DURING A PULSED FIELD ABLATION (PFA) PROCEDURE A FARASTAR PFA GENERATOR NAM WAS SELECTED FOR USE. THIS WAS A "RESEARCH CASE" THAT LASTED 3.5 HOURS. 56 FARAWAVE ABLATIONS WERE DELIVERED TO PATIENT. 16 L SUP, 16 L INF, 12 R SUP AND 12 R INF. OPAL WAS NOT INVOLVED AS THIS WAS A CARTO MAPPING CASE. CASE WAS COMPLETED THERE WERE NO REMARKS FROM DR. NO MORE INFORMATION AVAILABLE.

  Patient problems: Non specific EKG/ECG Changes; Pericarditis

  MAUDE report 22666128 ↗
• MalfunctionJul 10, 2025Nonstandard Device; Defective Device; Nonstandard Device; Defective Device

  IT WAS REPORTED THAT DURING A PULSED FIELD ABLATION (PFA) PROCEDURE A FARASTAR PFA GENERATOR WAS SELECTED FOR USE. AFTER DELIVERING 67 APPLICATIONS, THE CONSOLE DISPLAYED THE 301 ERROR. THE CATHETER AND CABLE WERE REPLACED, IT WAS ATTEMPTED TO BYPASS THE CATHETER BUT THE ISSUE PERSISTED. THE PROCEDURE HAD TO BE CANCELLED DUE TO THIS ISSUE. THIS COMPLAINT IS BEING REPORTED DUE TO AN ABORTED PROCEDURE WITH THE PATIENT UNDER SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22475477 ↗
• MalfunctionMay 22, 2025Nonstandard Device; Connection Problem; Material Integrity Problem; Nonstandard Device; Connection Problem; Material Integrity Problem

  CLINICAL INFORMATION: (B)(4) STUDY, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2024, A 22MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT USING A 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. THE LEFT ATRIAL APPENDAGE (LAA) DEPTH WAS 25MM. DURING PROCEDURE, THE LEFT ATRIAL PRESSURE WAS 18MMHG, ATRIAL RHYTHM RECORDED AT START OF PROCEDURE WAS NON-SINUS RHYTHM (NSR), ACTIVATED CLOTTING LEVELS WERE 248S-290S AND HEPARIN WAS ADMINISTERED. THE AMULET WAS SUCCESSFULLY DEPLOYED IN THE LAA. ON (B)(6) 2025 ON THE WAY FROM WORK, THE PATIENT DEVELOPED LEFT SIDED PARALYSIS AND WAS RUSHED TO THE HOSPITAL. A HEAD COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THE PATIENT HAD A CEREBRAL INFRACTION. THE PATIENT UNDERWENT TISSUE PLASMINOGEN ACTIVATOR (TPA) TREATMENT AT HIGH CARE UNIT (HCU). ON (B)(6) 2025, THE PATIENT STOPPED TAKING BAYER ASPIRIN 100MG AND STARTED TAKING LIXIANA 30MG. ON (B)(6) 2025, THE PATIENT TRANSFERRED TO ANOTHER HOSPITAL. ON (B)(6) 2025, A TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) CONFIRMED THE ABSENCE OF THROMBUS IN THE LEFT ATRIUM AND THERE WAS NO FINDINGS NOTED THE CAUSE OF CEREBRAL INFRACTION. THE PATIENT'S OVERALL CONDITION STABILIZED AND GOT DI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22070656 ↗
• MalfunctionFeb 6, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT A FARASTAR GENERATOR WAS SELECTED FOR USE. A FARASTAR 301 ERROR OCCURRED, AND TROUBLESHOOTING STEPS INCLUDED REPOSITIONING THE CATHETER, CHANGING THE CATHETER AND CABLE, BUT THE ERROR PERSISTED. THE GENERATOR WAS POWER CYCLED AND MOVED TO ANOTHER HOSPITAL-GROUNDED POWER OUTLET, YET THE ERROR REMAINED. CONSEQUENTLY, THE PROCEDURE WAS NOT COMPLETED, AND IT IS UNKNOWN IF THE PATIENT WAS SEDATED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21324145 ↗
• MalfunctionNov 14, 2024Off-Label Use; Defective Device; Off-Label Use; Defective Device

  IT WAS REPORTED THAT DURING A PULSED FIELD ABLATION (PFA) PROCEDURE TO TREAT A RECURRENT PERSISTENT ATRIAL FIBRILLATION (OFF-LABEL USE) A FARASTAR PULSED FIELD ABLATION SYSTEM WAS SELECTED FOR USE. RECURRENT 301 ERRORS WERE DISPLAYED AFTER THE FIRST TWO DELIVERIES. NO SPLINE INVERSION WAS NOTICED ON ICE OR FLUORO. THE DEPLOYMENT WAS SUCCESSFUL; HOWEVER, THE SYSTEM ERROR RESTRICTED THE ENERGY DELIVERY. THE ERROR PERSISTED DESPITE REPLACING THE CABLE, CATHETER, SHEATH AND RESTARTING THE GENERATOR. THE PROCEDURE HAD TO BE CANCELLED AS THE PHYSICIAN WAS NOT PREPARED TO SWITCH TO RADIOFREQUENCY. THE PATIENT WAS ALREADY SEDATED WHEN THE PROCEDURE WAS CANCELLED. THE DEVICE RETURN FOR ANALYSIS IS UNKNOWN. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20687360 ↗
• MalfunctionNov 14, 2024Off-Label Use; Defective Device; Off-Label Use; Defective Device

  DURING A PERSISTENT ATRIAL FIBRILLATION (OFF-LABEL USE) PULSE FIELD ABLATION (PFA) PROCEDURE A FARASTAR GENERATOR WAS SELECTED FOR USE. DURING PROCEDURE, AFTER TWO APPLICATIONS OF PFA IN THE 301-ERRORS WERE REPORTED. TROUBLESHOOTING WAS PERFORMED, THE GENERATOR WAS RESTARTED WITHOUT SUCCESS. IT WAS ATTEMPTED TO REPOSITION IN THE PULMONARY VEIN TO RULE OUT ANATOMY CHALLENGES AND REPLACEMENT OF THE CATHETER, BUT THE 301-ERROR PERSISTED. SINCE THE ERROR COULD NOT BE SOLVED THE PROCEDURE WAS ABORTED. AT THE TIME OF THE ERROR NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20687050 ↗

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-2751-2026 · Jun 11, 2026 · Open, Classified
  FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; 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-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