FARASTAR™ M004PF41M434Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00191506041656), received between Jan 2, 2025 and Nov 25, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Contamination” (9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionNov 10, 2025Contamination; Contamination

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. DURING PREPARATION FOR A PULSE FIELD ABLATION PROCEDURE, A FARASTAR CATHETER CONNECTION CABLE BECAME CONTAMINATED IN AN UNKNOWN MANNER. THE PROCEDURE WAS COMPLETED WITH A NEW FARASTAR CATHETER CONNECTION CABLE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23510419 ↗
• MalfunctionOct 24, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING PREPARATION FOR THE FARAWAVE PROCEDURE FOR ATRIAL FIBRILLATION, WHEN THE BOX WAS OPENED IT WAS NOTICED THAT THE PLASTIC BAG TO THE FARASTAR CATHETER CONNECTION CABLE WAS SLIGHTLY OPEN. THE STICKER THE BOX WAS INTACT. A NEW CONNECTION CABLE WAS USED TO ENSURE STERILITY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE WAS CONTAMINATED AND NOT EXPECTED TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23379924 ↗
• MalfunctionSep 15, 2025Contamination; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Contamination; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE STERILE PACKAGING OF A FARASTAR CATHETER CONNECTION CABLE WAS EASILY DAMAGED DURING OPENING. DURING PREPARATION FOR A PROCEDURE, A FARASTAR CATHETER CONNECTION CABLE WAS SELECTED FOR USE. HOWEVER, WHILE PREPARING THE DEVICE, THE STERILE PACKAGING TORE APART. THE ORIGINAL DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. IT IS UNKNOWN IF THE PACKAGING WILL RETURN FOR LABORATORY ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23049171 ↗
• MalfunctionSep 5, 2025Contamination; Difficult to Open or Remove Packaging Material; Contamination; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT FOR A PULSE FIELD ABLATION (PFA) PROCEDURE TO TREAT AN ATRIAL FIBRILLATION A FARASTAR CATHETER CONNECTION CABLE WAS SELECTED FOR USE. DURING CABLE PREPARATION, STAFF WAS OPENING PACKAGING AND THERE WAS AN ISSUES WITH A STUCK SEAL AND THE CABLE POPPED OUT TOUCHED THE EXTERNAL PART OF THE PACKAGING, THUS CONTAMINATING THE CABLE. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT EXPECTED TO RETURN FOR ANALYSIS AS IT WAS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22979198 ↗
• MalfunctionAug 13, 2025Contamination; Delivered as Unsterile Product; Difficult to Open or Remove Packaging Material; Contamination; Delivered as Unsterile Product; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT A FARASTAR CATHETER CONNECTION CABLE WAS SELECTED FOR USE. DURING CABLE PREPARATION, THE STERILE PACKAGING DID NOT TEAR IN THE CORRECT PLACE AND THE PACKAGING TORE DOWN THE MIDDLE OF THE PAPER RESULTING IN THE CABLE FALLING OUT AND BECOMING UNSTERILE. IT WAS NOTED THAT THERE IS "POOR QUALITY OF STERILE PACKAGING". THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE WAS RETURNED FOR LABORATORY ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22793438 ↗
• MalfunctionJun 5, 2025Contamination; Contamination

  DURING A PULMONARY VEIN ISOLATION TO TREAT AN ATRIAL FIBRILLATION, A FARASTAR CATHETER CONNECTION CABLE WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE PAPER ON THE PACKAGING DID NOT TEAR ALONG THE GLUED EDGES AND INSTEAD BECAME TORN DOWN THE MIDDLE UPON OPENING. BECAUSE THE CABLE IS PACKAGED INSIDE THIS WITHOUT A TRAY THE END OF THE CABLE FELL OUT AND TOUCHED AN UNSTERILE PART OF THE PACKAGING. THE CABLE WAS REPLACED, AND PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. THE DEVICE IS NOT EXPECTED TO BE RETURNED AS IT WAS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22152956 ↗
• MalfunctionMay 12, 2025Contamination; Tear, Rip or Hole in Device Packaging; Contamination; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE FARASTAR CATHETER CONNECTION CABLE PACKAGE WAS RECEIVED DAMAGED. THE SEAL WAS BROKEN, COMPROMISING THE STERILITY OF THE DEVICE. THE CABLE IS NOT EXPECTED TO RETURN AS IT WAS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22003318 ↗
• MalfunctionMay 5, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DURING A PULSED FIELD ABLATION (PFA) PROCEDURE TO TREAT AN ATRIAL FIBRILLATION A FARASTAR CATHETER CONNECTION CABLE PRESENTED AN ISSUE. WHEN THE PACKAGE WAS OPENED, IT WAS OBSERVED A SHINY, GLUE-LIKE SUBSTANCE ADHERED TO THE CABLE. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE HAS BEEN RECEIVED AT BOSTON SCIENTIFIC POST MARKET LABORATORY WHERE IT'S WAITING FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961807 ↗
• MalfunctionApr 22, 2025Contamination; Difficult to Open or Remove Packaging Material; Contamination; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT FOR A PULSE FIELD ABLATION (PFA) PROCEDURE TO TREAT AN ATRIAL FIBRILLATION, DURING CABLE PREPARATION, THE NURSE OPENED PACKAGING FROM TOP AND THE TWO ENDS OF CABLE HIT NONSTERILE AREAS OF PACKAGING, THE CABLE WAS CONTAMINATED AND REPLACED. THE REPORTED INCIDENT IS CLAIMED TO BE DUE TO POORLY DESIGNED PACKAGING. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE ISN'T EXPECTED TO RETURN FOR LABORATORY ANALYSIS AS IT WAS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21885599 ↗
• MalfunctionApr 21, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT FOR A PULSE FIELD ABLATION (PFA) PROCEDURE TO TREAT AN ATRIAL FIBRILLATION, UPON OPENED PACKAGING, SCRUB TECH REMOVED CABLE AND DEBRIS NOTED WITHIN PACKAGE. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 21875534 ↗
• MalfunctionFeb 26, 2025Contamination; Contamination

  IT WAS REPORTED THAT DURING A PROCEDURE, UPON OPENING THE BOX FOR THE FARASTAR CATHETER CONNECTION CABLE, THE STERILE SEAL WAS ALREADY OPENED. THE CABLE WAS UNABLE TO BE USED FOR THE PROCEDURE AS IT WAS NOT STERILE AND THEREFORE REPLACED. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS. THE CABLE IS NOT EXPECTED TO RETURN FOR ANALYSIS AS IT WAS DISPOSED. IT WAS FURTHER REPORTED, ADDITIONAL INFORMATION RECEIVED INDICATED THAT NO DAMAGE WAS NOTED ON THE OUTER BOX. LEFT SIDE OF THE INNER POUCH WAS ONLY PARTIALLY SEALED, HOWEVER OUTER BOX WAS SEALED PROPERLY. NO ADDITIONAL DAMAGE NOTED ON THE INNER PACKAGING/POUCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21474853 ↗
• MalfunctionJan 2, 2025Contamination; Difficult to Open or Remove Packaging Material; Contamination; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DURING PREPARATION FOR A PULSE FIELD ABLATION PROCEDURE WHEN THE FARASAR CABLE WAS OPENED IT WAS CONTAMINATED. THE PACKAGE WAS A LITTLE HARD TO OPEN, AND ONE END OF THE CABLE SLID OUT AND TOUCHED THE USERS FOREARM WHILE TRYING TO GET THE PACKAGE OPEN FOR THE SCRUB TECH. THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21060476 ↗

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-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-2750-2026 · Jun 11, 2026 · Open, Classified
  FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
• Z-2278-2025 · Jun 25, 2025 · Open, Classified
  FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401