VersaCross Connect Access Solution for FARADRIVERecalls & reported problems across all models

We found 4 models of VersaCross Connect Access Solution for FARADRIVE by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 289 adverse event reports in the FDA's MAUDE database, received between Apr 23, 2024 and Sep 22, 2026 — classified as 3 deaths, 124 injuries, 162 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (52 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported VersaCross Connect Access Solution for FARADRIVE problems

VersaCross Connect Access Solution for FARADRIVE models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• VersaCross Connect Access Solution for FARADRIVE VXAK0041

  Percutaneous Atrial Catheter Kit
  3 deaths275 reports
• VersaCross Connect Access Solution for FARADRIVE VXAK0045

  Percutaneous Atrial Catheter Kit
  12 reports
• VersaCross Connect Access Solution for FARADRIVE VXAK0043

  Percutaneous Atrial Catheter Kit
  1 report
• VersaCross Connect Access Solution for FARADRIVE VXAK0047

  Percutaneous Atrial Catheter Kit
  1 report

Recent VersaCross Connect Access Solution for FARADRIVE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that an allergic reaction occurred.A pulse field ablation procedure with transseptal puncture was performed using FARADRIVE sheath, FARAWAVE catheter and VersaCross Connect Radio Frequency (RF) wire. Immediately post procedure, patient became hypotensive, tachycardic and hypoxic. Protamine was reversed, saline was administered and a Transesophageal Echocardiogram (TEE) was performed. No pericardial effusion was observed, and patient began recovering and was admitted to the Intensive Care unit (ICU) for monitoring. The physician suspected that an allergic reaction to protamine had occurred. The patient was discharged from the hospital one day post index procedure.

  Patient problems: Hypersensitivity/Allergic reaction; Hypoxia; Low Blood Pressure/ Hypotension; Tachycardia

  MAUDE report 50856296 ↗
• InjurySep 22, 2026Difficult to Advance

  It was reported that the radiofrequency (RF) wire had difficulty to crossing the septum and advancing into the left atrium (LA) and the patient experienced cardiac tamponade, pericardial effusion, and hypotension.During an ablation procedure to treat paroxysmal atrial fibrillation a VersaCross Connect Access Solution for FARADRIVE RF Wire was used. A cavotricuspid isthmus ablation was performed with a non-Boston Scientific RF catheter prior to attempting the transseptal puncture (TSP). The VersaCross Connect for FARADRIVE system was positioned in optimal TSP position using fluoroscopy and intracardiac echocardiography (ICE). The RF Wire crossed the septum, but the tip got caught either on the septum or the LA free wall during the one second RF cautery period. There was some difficulty advancing the wire and the physician stated this did not feel normal. The FARADRIVE sheath was advanced into the LA, and the VersaCross Connect RF Wire and dilator were removed from the patient. Preparations were made to insert a non-Boston Scientific mapping catheter into the sheath, but it was found that the sheath had lost transseptal access. Another TSP was to be attempted with the RF Wire and dil

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 50852630 ↗
• MalfunctionSep 21, 2026Material Frayed

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848673 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 50829552 ↗
• MalfunctionSep 18, 2026Deformation Due to Compressive Stress; Material Integrity Problem

  It was reported that Guidewire Coating Issue occurred.It was reported that a VersaCross Mechanical Guidewire was selected for pulmonary vein isolation (PVI), pulmonary wall isolation (PWI), cavotricuspid isthmus (CTI) and mitral isthmus (MI) to treat atrial fibrillation (Afib). Prior to procedure, upon opening package, the guidewire was bent or kinked and frayed. Guidewire was replaced and procedure was completed without patient complications. Product return is not expected as it was disposed. It was further informed that the damage was observed in the mechanical guidewire and the coating was scraped. The fraying occurred in the proximal end of the guidewire. Additionally, there were no patient complication's reported, it was a good patient outcome.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819154 ↗
• InjurySep 15, 2026Difficult to Advance

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 50779973 ↗
• MalfunctionSep 8, 2026Material Perforation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50676104 ↗
• DeathSep 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Death, Cardiac Arrest, Ventricular Fibrillation, Ventricular Tachycardia, Hypotension and Bradycardia occurred.A concomitant procedure (ablation/left atrial appendage closure (LAAC)) was being performed. A WATCHMAN TruSteer Access System (WAS), a 31mm WATCHMAN FLX Pro LAA Closure Device and Delivery System (WDS), a FARAWAVE catheter and a VersaCross Connect Access Solution for FARADRIVE were selected for use. After the ablation portion of the procedure, the LAAC procedure was completed without any reported complications. Electrocardiogram (EKG) monitoring showed no ST-segment elevation or evidence of any lethal arrhythmias. At the conclusion of the procedure, the physician was in the process of closing the groin access site, and protamine was administered to reverse the effects of heparin anticoagulation. The anesthesia physician observed a sudden decline in the patient's blood pressure along with bradycardia. Cardiopulmonary resuscitation (CPR) was initiated. A transesophageal echocardiogram (TEE) was performed to evaluate for a potential pericardial effusion or cardiac tamponade as a cause of the hemodynamic instability. No pericardial effusion was identified

  Patient problems: Bradycardia; Cardiac Arrest; Low Blood Pressure/ Hypotension; Tachycardia; Ventricular Fibrillation

  MAUDE report 50670664 ↗
• MalfunctionSep 4, 2026Failure to Advance; Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50620080 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  It has been reported that bradycardia, pericardial effusion and cardiac tamponade occurred post procedure 3hrs later. VersaCross Connect Access Solution for Faradrive kit was selected for use and during a transesophageal echocardiogram (TTE), a pericardial effusion was noted. Patient was brought back into the room to get a Pericardiocentesis. Pigtail versacross was used in the procedure. The patient has been discharged. The VersaCross wire is not available for return as it was discarded at the end of the case.

  Patient problems: Bradycardia; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 50546349 ↗
• MalfunctionAug 24, 2026Difficult to Advance; Physical Resistance/Sticking

  It was reported that during Post Procedure/Prior to Discharge for a Pulse Field Ablation (PFA) procedure a VersaCross Connect Access Solution for Faradrive RF wire was selected for use. Posterior to transseptal procedure using Versacross connect, the wire could not be removed from the dilator. The procedure was completed with original device. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50399362 ↗
• MalfunctionAug 21, 2026Material Frayed; Difficult to Insert

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50372481 ↗
• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient experienced vision blurred and numbness in the left arm. During a Pulse Field Ablation Procedure (PFA) to treat atrial fibrillation a FARAWAVE Cathether and a VersaCross Connect Access Solution for FARADRIVE were selected for use. No issues with the transseptal puncture was reported. Right Inferior Pulmonary Vein (RIPV) was extremely small, while in basket, 301 errors were received, catheter was repositioned and still received errors and ultimately the catheter formed a cobra shape. It was removed the catheter and manually separated the splines, went back into the Left Atrium (LA) and tried to reattempt basket in the RIPV, catheter went cobra again. There was difficulty delivering the basket into the RIPV. Bubbles appeared while delivering in basket configuration due to something that typically occurs which is caused by an inadequate tissue contact because the basket is undersized. If the electrodes are too close, the system has a built-in safety mechanism that automatically discontinues energy delivery. Physician indicated that there may have been excessive therapy delivery in the RIPV region. Physician believes that 301 errors and additional applica

  Patient problems: Blurred Vision; Numbness

  MAUDE report 50228399 ↗
• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced hemorrhage, pseudoaneurysm. A pulmonary vein isolation (PVI) procedure was performed as planned, with no complications reported. Following completion of the procedure and closure of the access site, the patient was observed to have greater-than-expected bleeding from the incision site. In response, manual pressure was applied and a device was placed to control the bleeding. Subsequently, during post-procedural monitoring, the patient developed a pseudoaneurysm at the access site. The following day, the patient was admitted to the hospital for further evaluation and monitoring.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pseudoaneurysm

  MAUDE report 50223119 ↗
• InjuryAug 3, 2026Device-Device Incompatibility; Difficult to Advance

  During procedure for a Pulse Field Ablation (PFA) and a Watchman Left Atrial Appendage Closure (LAAC) FLX Pro procedure to treat Atrial Fibrillation a VersaCross Connect Access Solution for FARADRIVE and a Farawave Ablation Catheter were selected for use. Procedure started at 13:00, with a patient cleared for pericardial effusion at the beginning of case by the physician. Physician experienced difficulty getting the VersaCross into the Superior Vena Cava (SVC) due to pacer leads, wire was exchange for J-tipped (Non-BSC) wire to navigate through leads, once inside SVC wire was exchanged again. Upon dropping down onto the fossa to perform transeptal puncture, with no felt resistance or difficulty, it was noted the septum was thickened, which lead to an unsuccessful first attempt to cross, second attempt was successful. Then, patient had ablation performed with no symptoms and/or decompensation. Watchman sheath was inserted at 13:58, pigtail was placed into LAA and angio was performed. Drawing was marked on fluoroscopy and selected 31mm, it was prepared and inserted through Trusteer sheath. With the use of TEE Watchman was deployed and ran through PASS criteria. Implant was successful

  Patient problems: Pericardial Effusion

  MAUDE report 50112281 ↗

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