FARAPOINT™ M004PF81M110Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00191506047207), received between Sep 18, 2026 and Sep 30, 2026 — classified as 1 death, 2 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Sense; Connection Problem

  It was reported that during an ablation procedure a FARAPOINT was selected for use. During procedure, the catheter could not get connected for pacing due to recording system connection. Troubleshooting was attempted, including, reconnecting again and checking pinning, however, the issue persisted. The procedure was cancelled.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947811 ↗
• MalfunctionSep 30, 2026Connection Problem

  It was reported that during an ablation procedure a FARAPOINT was selected for use. During procedure, the catheter was connected, no signals were shown on mapping system or recording system, tried exiting study and looked at pinning. The catheter was replaced. The procedure was cancelled.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947810 ↗
• DeathSep 18, 2026Off-Label Use

  It was reported that the patient experienced bradycardia, hypotension, and cardiac arrest after the procedure. The patient died.During a cavotricuspid isthmus (CTI) ablation procedure to treat atrial flutter a FARAPOINT catheter was used. Use of the FARAPOINT catheter to treat atrial flutter constituted off-label use of the device per the Instructions For Use (IFU). Groin access was obtained under ultrasound guidance. The coronary sinus catheter and intracardiac echocardiography (ICE) catheter were placed, then the FARAPOINT catheter was inserted and advanced to the right atrium (RA). Mapping was performed with the FARAPOINT catheter before it was positioned at the TV annulus to begin ablation. 500mcg of intravenous (IV) nitroglycerin was administered prior to beginning ablation. Seventeen ablation applications were made under ICE and 3D mapping guidance. There were no ST segment changes observed on the 12-lead electrogram (ECG) while the procedure was ongoing. The procedure was completed and the patient was taken to the Post Anesthesia Care Unit (PACU) for recovery prior to being sent back to their inpatient room. Overnight the patient became bradycardic, hypotensive, and went int

  Patient problems: Bradycardia; Cardiac Arrest; Low Blood Pressure/ Hypotension; Pain

  MAUDE report 50818605 ↗

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-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-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