FARASTAR™ M004PF61M402Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00191506043698), received between Aug 5, 2025 and Jun 23, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• 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 ↗
• MalfunctionAug 11, 2025Device Emits Odor; Use of Device Problem; Unexpected Shutdown; Device Emits Odor; Use of Device Problem; Unexpected Shutdown

  IT WAS REPORTED THAT DURING A PULSE FIELD ABLATION (PFA) PROCEDURE USING A FARASTAR GENERATOR THE PROCEDURE WAS CANCELLED DUE TO A SYSTEM SHUT DOWN. DURING THE PROCEDURE THE SYSTEM SHUT DOWN AND COULD NOT BE RESTARTED. THERE WAS A BURNING ODOR COMING FROM THE GENERATOR. IT WAS ALSO REPORTED THAT IN MULTIPLE CASES BEFORE THE FINAL CASE THEY RECEIVED 306 CATHETER USAGE ERRORS THAT NEEDED TO BE BYPASSED. A FIELD SERVICE ENGINEER WAS SENT TO THE SIGHT AND OBSERVED BLOWN FUSES AND SPARKS FROM THE HV PRINTED CIRCUIT BOARD THAT LEFT BURN MARKS INSIDE THE GENERATOR. THE GENERATOR WAS THEN DEINSTALLED FROM THE SITE AND IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22768867 ↗
• MalfunctionAug 5, 2025Use of Device Problem; Device Displays Incorrect Message; Use of Device Problem; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING THE PROCEDURE, THERE WAS A CONSTANT E-0X303: ARC DETECT FAILURE AND 309 TREATMENT ERROR MESSAGES DISPLAYED AFTER PULSE NUMBER TWO. A NEW CABLE AND CATHETER WERE TRIED BUT THE ISSUE WAS NOT RESOLVED. THE PROCEDURE WAS CANCELED AFTER THE PATIENT WAS SEDATED. REPLACING THE CATHETERS DIDN'T RESOLVE THE ISSUE DUE TO THE FARASTAR DYEING. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE ISN'T EXPECTED TO RETURN FOR LABORATORY ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22714796 ↗

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-2753-2026 · Jun 11, 2026 · Open, Classified
  FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; 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-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