FARADRIVE™ M004PF21M402Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,303 adverse event reports that list this exact device (DI 00191506043131), received between Apr 18, 2024 and Sep 30, 2026 — classified as 15 deaths, 307 injuries, 1,981 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (1,384 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 11, 2026Open, Classified

   Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.

   Z-2756-2026 · Root cause: Use error · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 2,303 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941475 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pseudoaneurysm; Thrombosis/Thrombus

  MAUDE report 50926269 ↗
• InjurySep 28, 2026Air/Gas in Device

  FDA MedSun for Medwatch Notification:It was reported that that patient developed ST elevations during PFA "[Pulsed Field Ablation]" application of the RSPV that was sustained and associated with hypotension and inferior wall motion abnormalities. Suspect air bubbles from PFA sheath as cause of ST elevation. Post procedure, patient was found to have an air embolism in the brain causing ischemic injury (stroke).A FARADRIVE Sheath was selected for use to Atrial fibrillation. It was noted that the patient had preexisting Coronary heart disease. During the procedure, the Torflex catheter was exchanged for the FaraDrive sheath and inserted the Farawave catheter. The FaraDrive sheath was attached to continuous flush through a drip line that was carefully checked and prepped. The J-wire was positioned in each vein during the application. The patient developed transient ST elevations that self-resolved within 2 minutes after the basket pulses were delivered in the LSPV "[ Left Superior Pulmonary Vein]". No evidence of bubbles were seen in the cardiac chambers on ICE imaging and there appeared to be no bubbles in the sheaths. The patients hemodynamics were stable and it elected to move forwa

  Patient problems: Air Embolism; Heart Block; Ischemia Stroke; Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes; Tachycardia

  MAUDE report 50916734 ↗
• MalfunctionSep 24, 2026Leak/Splash; Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888909 ↗
• MalfunctionSep 24, 2026Air/Gas in Device

  It was reported that during a Pulse Field Ablation (PFA) procedure for the treatment of atrial fibrillation (AF), a FARADRIVE Steerable Sheath was selected for use. During withdrawal of the sheath from the left atrium, aspiration was performed as part of the removal process. At that time, a large quantity of air bubbles was observed mid-sheath while the sheath was being withdrawn from the body. All observed air bubbles were successfully aspirated, and the patient was assessed and monitored for signs and symptoms of air embolism and stroke. No air was observed in the patient, and the patient did not experience a stroke. The procedure was completed successfully using the device. No adverse patient effects or complications occurred, and the patient remained stable throughout and following the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888710 ↗
• MalfunctionSep 23, 2026Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876289 ↗
• MalfunctionSep 23, 2026Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50874513 ↗
• MalfunctionSep 21, 2026Nonstandard Device; Device-Device Incompatibility

  It was reported that during an atrial fibrillation ablation a FARADRIVE was selected for use. Groin was accessed with needle, starter guidewire was inserted, 12F coons dilator was inserted over the wire to pre-dilate, then it was removed and Faradrive with Versacross Connect for Faradrive was inserted over the wire. When the physician tried to insert the sheath and dilator through the groin it was stated that the sheath bunched up at the tip on the dilator because the transition was too abrupt. The dilator would not properly snap into the sheath. No abnormal force was used. No significant resistance was noticed when inserting the dilator. It occurred when attempting to insert the sheath through the access point. A new sheath and dilator were requested. While that was being prepped, a 14F coons dilator was used to further pre-dilate. The second sheath and dilator were inserted into the groin without incident. The procedure was completed without patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50839232 ↗
• MalfunctionSep 18, 2026Break

  Faradrive steerable sheath broke no pt Harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50818320 ↗
• InjurySep 18, 2026Difficult to Advance

  It was reported that patient experience Pericardial effusion and perforation.FARADRIVE Steerable Sheath Clear was selected for use. It was mentioned that once the transseptal was completed using versacross wire, the wire was sent into the left atrium. The Patient had thick septum, so was hard for the physician to push the sheath across. As per the physician opinion, Pericardial effusion occurred before ablation, when the physician pushed the Faradrive sheath too hard to cross, enabling the wire to puncture the LA. Perforation was noted in left atrium. Pericardiocentesis/TAP was performed and patient was transferred for Surgery into the OR (Operating Room). The Procedure was cancelled. Patient current status was unknown.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 50818191 ↗
• MalfunctionSep 18, 2026Air/Gas in Device

  It was reported that the sheath exhibited air bubbles in the irrigation tubing during aspiration.During a pulse field ablation (PFA) procedure to treat paroxysmal atrial fibrillation a FARADRIVE sheath was used. After insertion and introduction of the FARAWAVE catheter into the sheath aspiration was performed. Air bubbles were observed in the irrigation tubing. The sheath was replaced and the procedure was completed. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817425 ↗
• MalfunctionSep 17, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809241 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Pericardial effusion occurred. FARADRIVE Steerable Sheath was selected for use during farapulse pulsed field ablation. It has been mentioned that patient arrived in flutter during an Atrial fibrillation ablation under deep sedation. The ICE Catheter was introduced into right atrium and then right ventricle and scanned noting a baseline effusion around the basal aspect of the right ventricle. Transeptal was performed without issue noted and visualized under ICE. The ICE Catheter was introduced into the left atrium. A decapolar Coronary Sinus catheter was then placed into the Coronary sinus. An eccentric activation pattern was noted and suspected roof dependent flutter. All 4 veins were isolated and the flutter persisted. A posterior wall isolation was performed. Termination occurred during an application in flower. Pressure dropped following conversion and anesthesia noted they were not responding to pressors. The Farapulse catheter and Faradrive sheath were removed from the LA. ICE was then pulled back to the Right atrium and scanned the pericardium. An increase in the pericardial effusion was noted to approximately 1cm. Hepranization was reversed and anesthesi

  Patient problems: Atrial Flutter; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 50803247 ↗
• MalfunctionSep 17, 2026Fluid/Blood Leak

  It was reported that during preparations for a FARAPULSE procedure to treat paroxysmal atrial fibrillation, upon unpacking and flushing a FARADRIVE sheath. a drip like leak of saline was observed coming from the hemostatic valve. Nothing had been inserted inside the sheath at this point. The catheter was replaced with a similar device, and the procedure was completed. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802764 ↗
• MalfunctionSep 17, 2026Contamination

  It was reported that before a Pulse Field Ablation (PFA) procedure a Faradrive Sheath was selected for use, it was noted that the device had adhesive on side of sheath. The device was replaced and the procedure was completed successfully. No patient involvement was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802250 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pericardial Effusion

  MAUDE report 50796511 ↗
• MalfunctionSep 16, 2026Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50788142 ↗
• MalfunctionSep 15, 2026Nonstandard Device; Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777883 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It is reported that a ST Segment Elevation occurred.During an atrial fibrillation procedure, a FARADRIVE Steerable Sheath (clear) was selected. After going transseptal with a Versacross device, Physician went in with the mapping catheter, while mapping noticed ST elevations, physician pulled everything out and referred to Interventional Cardiology for cardiac catheterization. Physician stated that this patient must have coronary disease and that is what caused the ST Elevation. Patient was kept overnight for observation and discharged the next day. Procedure was incomplete (Aborted due to ST elevation).

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 50694249 ↗
• MalfunctionSep 9, 2026Air/Gas in Device

  It was reported that Visible Air/Bubbles occurred. It was reported that a FARADRIVE sheath was selected for a pulse field ablation (PFA) to treat an atrial fibrillation (AF). The sheath was prepared as normal, and no air was noted during the aspiration step. The sheath was flushed and aspirated correctly, and the dilator was inserted correctly. During insertion in the groin, the wire and dilator were removed. Then, aspiration was performed and no air was noted. The catheter was inserted into the sheath valve, and the guidewire was advanced approximately 10 cm. The physician performed two aspirations from the sheath, and both showed air in the sheath side port. Sheath was replaced and procedure was completed without patient complications. Product return is not expected as it was contaminated. It was further informed that no air was seen in the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50689658 ↗
• MalfunctionSep 8, 2026Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50677915 ↗
• MalfunctionSep 8, 2026Suction Problem

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50677486 ↗
• MalfunctionSep 8, 2026Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50675619 ↗
• MalfunctionSep 8, 2026Suction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50671609 ↗
• MalfunctionSep 8, 2026Fluid/Blood Leak; Device Contamination with Body Fluid; Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50670856 ↗