FARASTAR™ M004PF41M444Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00191506041663), received between Aug 22, 2025 and May 29, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Remove Packaging Material” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• 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 ↗
• MalfunctionAug 22, 2025Unsealed Device Packaging; Device Contamination with Chemical or Other Material; Unsealed Device Packaging; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOR A PULSE FIELD ABLATION (PFA) PROCEDURE TO TREAT AN ATRIAL FIBRILLATION A FARASTAR GEN 2 CONNECTION CABLE WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE DEVICE PACKAGE BOX WAS OPENED THE CABLE PACKAGING WAS DISCOVERED TO BE PARTIALLY OPEN. 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 22879517 ↗

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-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-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-2278-2025 · Jun 25, 2025 · Open, Classified
  FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401