FARASTAR™ M004PF61M601Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00191506043841), received between Jun 16, 2025 and Mar 23, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionJun 16, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A PULSED FIELD ABLATION (PFA) PROCEDURE THE FARASTAR MSM NAM WAS SELECTED FOR USE, DURING FARAVIEW CASE. DURING THE CASE, THE MAPPER OBSERVED ERROR 301 WHILE ATTEMPTING TO DELIVER PFA INITIALLY. MAPPER CONFIRMED ALL CONNECTIONS WHICH DID NOT RESOLVE THE ISSUE. MAPPER THEN EXCHANGED CATHETER WHICH DID NOT RESOLVE THE ISSUE. THE MAPPER REBOOTED THE ENTIRE SYSTEM. MAPPER AGAIN CONFIRMED THAT CONSOLE TO STIM CABLE WAS CONNECTED AND SECURE, THE RSM TO MSM AUX CABLE WAS CONNECTED AND SECURE, AND BOTH RSM AND MSM WERE POWERED ON AND IN A READY STATE (NOT TEST MODE). MAPPER THEN DELIVERED THERAPY SUCCESSFULLY. MAPPER TRIED TO DELIVER THERAPY A SECOND TIME AND AGAIN GOT 301. PHYSICIAN ASSURED GOOD CATHETER POSITION AND AGAIN ATTEMPTED TO DELIVERY THERAPY WHICH AGAIN PRODUCED A 301 ERROR. THE CATHETER WAS THEN CONNECTED DIRECTLY TO THE FARASTAR CONSOLE (BYPASSING THE MSM). THE TEAM WAS ABLE TO DELIVERY THERAPY SUCCESSFULLY THREE TIMES IN A ROW. NO PATIENT COMPLICATIONS WERE REPORTED. IT IS UNKNOWN IF THE FARASTAR DEVICE IS EXPECTED TO BE RETURNED. IT WAS FURTHER REPORTED THAT THE CASE WAS CANCELLED MID-PROCEDURE BECAUSE THE OPAL MAPPING SYSTEM COULDN'T BE USED; ON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22214586 ↗

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