VersaCross Access SolutionRecalls & reported problems across all models

We found 15 models of VersaCross Access Solution by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 69 adverse event reports in the FDA's MAUDE database, received between May 20, 2025 and Sep 29, 2026 — classified as 5 deaths, 30 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (18 reports).

1 FDA recall record name at least one of these models by its device 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. 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

VersaCross Access Solution recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 10, 2025Open, Classified

   Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.

   Z-2103-2025 · Root cause: Packaging change control · names 15 of these models · Recall details · FDA record ↗

Most reported VersaCross Access Solution problems

VersaCross Access Solution models

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

• VersaCross™ Access Solution VXSK0122

  Percutaneous atrial catheter kit
  1 recall2 deaths21 reports
• VersaCross™ Access Solution VXSK0131

  Percutaneous atrial catheter kit
  1 recall2 deaths12 reports
• VersaCross™ Access Solution VXSK0132

  Percutaneous atrial catheter kit
  1 recall11 reports
• VersaCross™ Access Solution VXSK0134

  Percutaneous atrial catheter kit
  1 recall1 death11 reports
• VersaCross™ Access Solution VXSK0121

  Percutaneous atrial catheter kit
  1 recall6 reports
• VersaCross™ Access Solution VXSK0124

  Percutaneous atrial catheter kit
  1 recall5 reports
• VersaCross™ Access Solution VXSK0101

  Percutaneous atrial catheter kit
  1 recall2 reports
• VersaCross™ Access Solution VXSK0123

  Percutaneous atrial catheter kit
  1 recall1 report
• VersaCross™ Access Solution VXSK0102

  Percutaneous atrial catheter kit
  1 recall0 reports
• VersaCross™ Access Solution VXSK0103

  Percutaneous atrial catheter kit
  1 recall0 reports
• VersaCross™ Access Solution VXSK0111

  Percutaneous atrial catheter kit
  1 recall0 reports
• VersaCross™ Access Solution VXSK0112

  Percutaneous atrial catheter kit
  1 recall0 reports
• VersaCross™ Access Solution VXSK0125

  Percutaneous atrial catheter kit
  1 recall0 reports
• VersaCross™ Access Solution VXSK0133

  Percutaneous atrial catheter kit
  1 recall0 reports
• VersaCross™ Access Solution VXSK0137

  Percutaneous atrial catheter kit
  1 recall0 reports

Recent VersaCross Access Solution adverse event reports

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

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during a left atrial appendage (LAA) procedure under general anesthesia, a VersaCross Access Solution was used for transseptal access. Baseline imaging with TEE identified a pre-existing pericardial effusion measuring 0.7 cm, with fluid noted behind the LAA and around the RV. A non-Boston Scientific mapping Catheter was used intra-procedurally. The physician performed a transseptal puncture using an 8.5F fixed VersaCross sheath and VersaCross pigtail wire. After the wire was advanced into the LAA and the sheath withdrawn, a non-Boston Scientific sheath was loaded over the wire. At that time, the ICE representative noted a growing pericardial effusion, which was subsequently confirmed by TEE. The patient became hemodynamically unstable with a drop in blood pressure, prompting emergent pericardiocentesis. Approximately 1,500 mL of bright red blood was evacuated and returned to the patient via cell saver autotransfusion. Due to continued blood re-accumulation, the patient was transferred to surgery, where an LAA perforation attributed to the VersaCross wire was reportedly confirmed and managed with a pericardial window and LAA clipping. On the following day, the p

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

  MAUDE report 50933346 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It has been reported that cardiac tamponade and perforation had occurred.During the pulmonary vein isolation procedure VersaCross Access Solution kit was selected for use. It has been mentioned that the access was obtained to right femoral vein and transeptal puncture was performed with access to the left atrium. About 20 seconds after transeptal puncture pressures began to rapidly decrease and cardiac perforation was noted. Pericardiocentesis was performed and patient was transferred to higher level of care for cardiac surgery. There was a tear in the left atrial appendage, and the appendage was surgically clipped. The patient was recovering in intensive care and now patient has been discharged from the hospital.

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

  MAUDE report 50855196 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient experience Pericardial effusion and perforation.VersaCross Connect Access Solution 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; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 50817475 ↗
• MalfunctionSep 16, 2026Failure to Advance

  It was reported that the septum could not be crossed.It was reported that during a pulse field ablation (PFA) procedure for the treatment of paroxysmal atrial fibrillation, a VersaCross Access Solution RF Wire was used to obtain transseptal access for pulmonary vein isolation (PVI). Following two unsuccessful attempts to cross the septum using RF energy ("buzz"), the physician increased the RF application duration, repositioned the wire, and confirmed optimal tenting of the septum. Despite three additional attempts, the wire was unable to cross the septum. The device was removed and replaced with another VersaCross device. The procedure was completed successfully using an alternate VersaCross Connect device. No patient complications were reported, and the patient remained stable throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50788573 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Thrombosis occurred.It was reported that a VersaCross RF Wire was selected to treat atrial fibrillation (Afib). During procedure, patients activated clotting times (ACTs) were not therapeutic and a clot formed on right side of the heart. They were 244 then down to 233 and then up to 360 at discovery of thrombus on wire in right atrium (RA). There were no device issues reported. Product return is not expected as it was disposed.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50756610 ↗
• DeathAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced cardiac tamponade, pericardial effusion, and perforation of the left atrial appendage. The patient died.During a pulse field ablation (PFA) procedure to treat paroxysmal atrial fibrillation a VersaCross Access Solution radiofrequency (RF) wire was selected for use. A VersaCross fixed sheath was used with the RF wire to perform the transseptal puncture (TSP). It was noted that the RF wire went across the septum without delivery of RF energy. The physician spent some time checking intracardiac echocardiography (ICE) imaging before dilating the septum with the VersaCross fixed sheath. It was noted that the RF wire did not appear as it normally did going out the left superior pulmonary vein (LSPV) on fluoroscopy, though it did not appear entirely abnormal either. The VersaCross fixed sheath was exchanged for the FARADRIVE. With the FARAWAVE catheter inserted past the sheath handle and into the clear shaft, the sheath was aspirated. Only air was aspirated from the sheath; the air was observed being drawn back from the tip of the FARAWAVE catheter. The FARAWAVE catheter was removed, but air continued to be aspirated. The sheath was exchanged,

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 50255873 ↗
• InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pericardial Effusion

  MAUDE report 50240115 ↗
• MalfunctionAug 10, 2026Failure to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50197014 ↗
• InjuryAug 7, 2026Off-Label Use; Adverse Event Without Identified Device or Use Problem

  It was reported that pericardial effusion, hypotension and tachycardia occurred.A pulmonary vein isolation (PVI) procedure utilizing pulse field ablation (PFA) was planned for the treatment of paroxysmal atrial fibrillation. A VersaCross Access Solution was selected for transseptal access. During the procedure, the physician performed transseptal puncture using the VersaCross RF wire through a non-Boston Scientific (non-BSC) sheath. RF energy was delivered via a Baylis generator, and the non-BSC sheath was advanced over the wire. No resistance was encountered while advancing or maneuvering any catheters or devices, and no issue was noted during the transseptal access. Following successful transseptal access, the VersaCross RF wire was removed. During left atrial mapping with a non-BSC Mapping Catheter and prior to delivery of any ablation lesions, the patient became hemodynamically unstable, with a decrease in blood pressure and an increase in heart rate. Evaluation identified a pericardial effusion. The physician withdrew the equipment into the right atrium and performed pericardiocentesis with placement of a pigtail drain. The effusion was treated before progression to cardiac ta

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion; Tachycardia

  MAUDE report 50175687 ↗
• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that pericardial effusion and cardiac perforation occurred. A left atrial appendage (LAA) closure procedure was being performed, and a VersaCross Access Solution was selected to be used. During the procedure the physicians performed a standalone closure device implantation on a patient with a known baseline pericardial effusion that was confirmed during the pre-procedure imaging assessment. The patient had two pacemaker leads and significant scoliosis, resulting in cardiac rotation and creating challenges with transseptal access. The physician experienced difficulty engaging the fossa ovalis due to the rotated anatomy, and visualization of the optimal tenting location was further complicated by the presence of the pacemaker leads. To improve septal engagement, the physician exchanged for a VersaCross kit to achieve additional curvature. During one of the attempts to drop down onto the septum, the exact tenting location could not be clearly visualized. The physician reported feeling a pop and advanced the wire, however, fluoroscopy showed the wire in an unusual, very posterior position. Recognizing this, the physician immediately withdrew the wire without advancing t

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

  MAUDE report 50124149 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  During an atrial fibrillation procedure, a VXSK (180P RF Wire, 63cm/55deg/D1) was selected. During the procedure, after the physician got access, he put a non-Boston Scientific ICE catheter in and then he placed the Cosronary Sinus (CS) catheter in the CS. When physician positioned his ICE catheter for transseptal it was noted that the patient had a very thick superior as well as inferior limbus, and that the fossa was very small for crossing into the Left Atrium (LA). He then advanced the VersaCross fixed sheath with RF wire and got that positioned the fossa for transseptal. Once he confirmed that he had maximal tenting in a safe location that was not too anterior nor too posterior, RF was delivered then the wire was confirmed in the left atrium via visualization with the ICE catheter and images were stored. The wire was advanced into the left inferior pulmonary vein (LIPV), which was confirmed on ICE as well as the use of the non-Boston Scientific mapping system, the mapper commented that the wire was taking a posterior trajectory. The physician "flossed" the septum by advancing the VersaCross sheath and dilator over the wire at the septum multiple times. Then he pulled the sheat

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

  MAUDE report 50038626 ↗
• InjuryJul 27, 2026Off-Label Use

  It was reported that a patient experienced a pericardial effusion growing to a cardiac tamponade following a cardiac perforation requiring a pericardiocentesis, exploratory open-heart surgery, medication, and extended hospitalization. The ablation procedure was unable to be completed due to this adverse event.A VersaCross Access Solutions kit was selected for use for the transseptal access portion of a FARAPULSE procedure to treat atrial fibrillation. Femoral access was achieved and a non-Boston Scientific (BSC) sheath and the Radio Frequency (RF) Pigtail wire from a fixed curve VersaCross kit were advanced into the Superior Vena Cava (SVC) with the use of Intracardiac Echocardiography (ICE). At this time, ICE showed a trace amount of effusion in the pericardial space. The non-BSC sheath was dropped down onto the atrial septum for transeptal access. Access was gained on the mid septum with veins in view. The RF Pigtail wire was advanced into the left superior pulmonary vein (LSPV) and the non-BSC sheath was advanced into the left atrium. The non-BSC dilator and RF Pigtail wire were removed. The non-BSC sheath was aspirated and flush. A Merit guidewire and non-BSC mapping catheter w

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 50000315 ↗
• MalfunctionJul 20, 2026Off-Label Use; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25883956 ↗
• MalfunctionJul 15, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING CARDIAC CATHERIZATION PROCEDURE A VERSACROSS ACCESS SOLUTION WAS SELECTED FOR USE, PHYSICIAN OBTAINED FEMORAL VENOUS ACCESS USING A 4FR MICRO SHEATH. AN ATTEMPT WAS MADE TO EXCHANGE THE 4FR MICRO SHEATH FOR THE 8.5 VERSACROSS SHEATH. TRIED TO REMOVE THE WIRE BUT IT WAS STUCK IN THE VERSACROSS DILATOR. THUS, HAD TO REMOVE THE DILATOR AND OPEN A NEW VERSACROSS TO REPLACE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25829196 ↗
• InjuryJul 8, 2026Failure to Advance; Mechanics Altered

  It was reported that pericardial effusion occurred.A pulse field ablation procedure was performed for the treatment of atrial fibrillation using a Veracross Access solution and FARAWAVE catheter. Prior to transseptal system insertion, a pericardial effusion was documented. The patient was noted to have a persistent left superior vena cava (SVC), which made positioning and use of the VersaCross system and non-Boston Scientific transeptal needle challenging. Electrophysiologist (EP) noted a concern regarding the RF wire curve. During the procedure, the RF wire was advanced to perform transseptal crossing. Multiple attempts were required due to difficulty crossing the septum. A new VersaCross Access Solution kit was opened and used to successfully complete the transseptal puncture. Following completion of the transseptal puncture, an increase in pericardial effusion was observed approximately 60 minutes after access was obtained. Pericardiocentesis was performed, and approximately 600 mL of blood was drained using an effusion management kit. The patient was stabilized and the procedure was completed, including successful isolation of the pulmonary veins and posterior wall. The patient

  Patient problems: Pericardial Effusion

  MAUDE report 25756488 ↗

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