VersaCross Connect LAAC Access SolutionRecalls & reported problems across all models

We found 5 models of VersaCross Connect LAAC Access Solution by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 136 adverse event reports in the FDA's MAUDE database, received between May 7, 2025 and Sep 29, 2026 — classified as 5 deaths, 78 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (22 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 LAAC Access Solution problems

VersaCross Connect LAAC Access Solution models

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

• VersaCross Connect™ LAAC Access Solution VXAK0107

  Percutaneous atrial catheter kit
  3 deaths77 reports
• VersaCross Connect™ LAAC Access Solution VXAK0103

  Percutaneous atrial catheter kit
  1 death25 reports
• VersaCross Connect™ LAAC Access Solution VXAK0105

  Percutaneous atrial catheter kit
  1 death14 reports
• VersaCross Connect™ LAAC Access Solution VXAK0101

  Percutaneous atrial catheter kit
  10 reports
• VersaCross Connect™ LAAC Access Solution VXAK0109

  Percutaneous atrial catheter kit
  10 reports

Recent VersaCross Connect LAAC 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 a patient experienced a thrombus.It was reported that during a WATCHMAN FLX Pro procedure to treat Left Atrial Appendage Closure (LAAC) a VersaCross Connect LAAC Access Solution was selected for use for transseptal access. The physician went into the body with the pigtail wire, followed by the double curve Watchman sheath and dilator, when waiting to go transseptal it was noticed a clot on the wire. It was noticed the dilator tip was damaged, so it replaced with a new Versacross connect. Then went back up and continued the procedure as normal, procedure was completed with no patient consequences observed. The Activated Clotting Time (ACT) resulted 215 and it was given 10,000 more units of heparin. The irrigation flow was not interrupted during procedure. It was then pulled everything back and flushed everything out. Irrigation flow rate is unknown. TEE was used to rule out thrombus before the procedure. It is unknown if procedure performed was interrupt on anticoagulation regime. Time passed between initial ACT and last ACT recorded is unknown. Following ACT was greater than 400. No fibrin or coagulant was seen at the tip of the catheter. Anticoagulation status

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50936655 ↗
• InjurySep 29, 2026Nonstandard Device

  It was reported that a patient experienced a thrombus.It was reported that during a WATCHMAN FLX Pro procedure to treat Left Atrial Appendage Closure (LAAC) a VersaCross Connect LAAC Access Solution was selected for use for transseptal access. The physician went into the body with the pigtail wire, followed by the double curve Watchman sheath and dilator, when waiting to go transseptal it was noticed a clot on the wire. It was noticed the dilator tip was damaged, so it replaced with a new Versacross connect. Then went back up and continued the procedure as normal, procedure was completed with no patient consequences observed. The Activated Clotting Time (ACT) resulted 215 and it was given 10,000 more units of heparin. The irrigation flow was not interrupted during procedure. It was then pulled everything back and flushed everything out. Irrigation flow rate is unknown. TEE was used to rule out thrombus before the procedure. It is unknown if procedure performed was interrupt on anticoagulation regime. Time passed between initial ACT and last ACT recorded is unknown. Following ACT was greater than 400. No fibrin or coagulant was seen at the tip of the catheter. Anticoagulation status

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50936654 ↗
• InjurySep 28, 2026Difficult to Advance

  Patient problems: Pericardial Effusion

  MAUDE report 50916423 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced pericardial effusion, cardiac tamponade and hypotension.During a left atrial appendage closure (LAAC) procedure, a Versacross RF wire was selected for transseptal access. Prior to the procedure, a small pericardial effusion was identified on imaging. The WATCHMAN FXD Curve Access System (WAS) with VersaCross RF wire was positioned posteriorly for the initial transeptal puncture (TSP). The physician reported difficulty advancing the sheath across the septum. A second transseptal puncture was subsequently performed. The RF wire was advanced into the left atrial appendage (LAA) and then exchanged for a pigtail catheter. A 24 mm WATCHMAN FLX Pro LAA Closure and Delivery System (WDS) was initially selected; however, the device appeared too distally pinched and was removed. The device was exchanged for a 20 mm WATCHMAN FLX Pro WDS. The 20 mm WATCHMAN FLX Pro device was successfully deployed and implanted in the LAA. At the conclusion of the procedure, the pre-existing pericardial effusion was noted to have increased in size and the patient blood pressure decreased. A pericardiocentesis was performed, and approximately 550 cc of bright red bloo

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

  MAUDE report 50854472 ↗
• InjurySep 22, 2026Off-Label Use

  It was reported that a patient experienced Cardiac Perforation and Pericardial Effusion.During withdraw for a Pulsed Field Ablation (PFA) procedure to treat atrial fibrillation a VersaCross Connect LAAC Access Solution RF wire was selected for use. Patient has Inferior Vena Cava (IVC) filter, which was difficult to gain access through. Also, patient has unusual anatomy with acute angles through IVC into right atrium. A small initial trace effusion was noted using Intracardiac Echocardiography (ICE). Physician performed transseptal procedure with versacross and Non-BSC sheath. No issue to visualize the wire. Wire tented a normal amount. After, Pulmonary Vein Isolation (PVI) and Pulmonary wall Isolation (PWI) ablation were completed with no observable complications. No malfunctions reported for BSC versacross or farawave. A resistance to move Non-BSC sheath into the right Atrium from the IVC. Nonetheless, 20 minutes post ablation, making use of ICE, a larger effusion was identified. Pericardiocentesis was performed, with not full drainage or fix of the effusion. The case was escalated to and managed by the Cardiothoracic surgeons, finding a tear, lateral & posterior IVC tear at RA ju

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 50850409 ↗
• InjurySep 21, 2026Device Sensing Problem

  Patient problems: Cardiac Perforation

  MAUDE report 50849209 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50848977 ↗
• MalfunctionSep 18, 2026Nonstandard Device

  It was reported that during a WATCHMAN FLX Pro implantation procedure, a VersaCross Connect LAAC Access Solution kit was selected for use in the transseptal puncture. Tip damaged was observed during insertion of the dilator into the sheath, and the original access kit was not used. It was noted that the dilator tip looked jagged. A new VersaCross Connect LAAC Access Solution kit was used to complete the procedure as planned. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817243 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that pericardial effusion, chest pain, hypotension and thrombosis occurred. During a left atrial appendage closure (LAAC) procedure, a VersaCross Connect LAAC Access Solution was selected for use. The patient was known to have a patent foramen ovale (PFO), an extremely aneurysmal septum, and difficult anatomy with a rotated heart. The procedure was performed under uninterrupted anticoagulation; however, the patient's anticoagulation status prior to the procedure was unknown. After groin access was obtained and before transseptal puncture (TSP), a full dose of heparin was administered. The initial activated clotting time (ACT) was 222 seconds. The implanting physician was reportedly surprised by the low ACT value and instructed that additional heparin be administered, although the amount administered was unknown. ACT values remained below 300 seconds until near the end of the procedure. The physician planned to cross the septum above the PFO device rather than through it. While advancing the looped VersaCross wire toward the superior vena cava (SVC), the wire and sheath repeatedly advanced through the PFO, requiring multiple positioning attempts. Fluoroscopy was used

  Patient problems: Chest Pain; Low Blood Pressure/ Hypotension; Pericardial Effusion; Thrombosis/Thrombus

  MAUDE report 50732343 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced pericardial effusion after the transseptal puncture (TSP).During a concomitant left atrial appendage procedure (LAAC) and radiofrequency (RF) ablation procedure a VersaCross Connect LAAC Access Solution RF Wire was used. Femoral access was gained; a non-Boston Scientific Intracardiac Echocardiography (ICE) catheter was inserted into the right atrium (RA), a non-Boston Scientific coronary sinus (CS) catheter was inserted and positioned at the CS, and a non-Boston Scientific sheath was inserted over a non-Boston Scientific .032-inch J-tip guidewire and positioned at the septum. The J-wire was exchanged for the VerasCross Connect RF Wire and the TSP was performed. The non-Boston Scientific sheath dilator was used with the RF Wire. The physician was not satisfied with the position of the TSP, so the RF Wire was pulled back into the RA, and the TSP procedure was repeated in an inferior/posterior location. Difficulty was encountered advancing the sheath across the septum, and the physician had to push a little harder to get it across. It was stated that the RF Wire may have also advanced across the septum when the sheath did. A routine imaging

  Patient problems: Pericardial Effusion

  MAUDE report 50691337 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that pericardial effusion and cardiac tamponade occurred. A left atrial appendage closure (LAAC) procedure was being performed. A VersaCross Connect LAAC Access Solution kit, WATCHMAN FXD Curve Access System and a 20mm WATCHMAN FLX Pro Delivery System were selected for use. The patient was noted to have a small appendage, making the procedure more challenging. After two attempts and recaptures of the 20mm device a larger 24mm WDS was deployed. As the physician checked the views on the transesophageal echocardiography (TEE) the patient blood pressure dropped. A growing effusion was noted. The physician prepped for pericardiocentesis, and anesthesia worked on stabilizing blood pressure. Cardiac surgery was called in as back up. A pericardial drain was placed and about 450 ml of blood was drained at this point. The 24mm WDS and the double curve WAS were removed. The patient was given protamine to reverse anticoagulation. About 1200ml of blood was drained. The blood was re-transfused back into the patient, and an additional two units of blood were given. The patient continued to decline and was brought to the operating room where the LAA was clipped. After clipping the

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

  MAUDE report 50615752 ↗
• InjurySep 2, 2026Difficult to Advance

  It was reported a pericardial effusion occurred. VersaCross Connect Access Solution was selected for use. Transesophageal Echocardiography (TEE) imaging noted a trace effusion prior to the procedure. The initial transeptal puncture (TSP) was difficult to perform due to a sharp posterior-inferior bend in the patient's anatomy. The physician attempted to cross the septum several times using the VersaCross Connect wire, crossing was made with the same RF wire. A proximal and distal bend were added to the TruSteer sheath and dilator, same dilator was use. After physician deployed the Closure Device, and completed a sweep, TEE imaging showed no change in effusion. Approximately thirty minutes post deployment, the patient's blood pressure dropped. TEE imaging noted the effusion near the apex of the left ventricle. Physician performed a pericardiocentesis to treat the effusion, draining an unknown amount of dull colored fluid. Patient was stabilized and was admitted to intensive care unit. There were no further complications and approximately three days post procedure, the patient was discharged.It was further confirmed that RF was applied each time. Multiple attempts required to track up

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 50572336 ↗
• InjurySep 2, 2026Positioning Failure

  It was reported a pericardial effusion occurred. VersaCross Connect Access Solution was selected for use. Transesophageal Echocardiography (TEE) imaging noted a trace effusion prior to the procedure. The initial transeptal puncture (TSP) was difficult to perform due to a sharp posterior-inferior bend in the patient's anatomy. The physician attempted to cross the septum several times using the VersaCross Connect wire, crossing was made with the same RF wire. A proximal and distal bend were added to the TruSteer sheath and dilator, same dilator was use. After physician deployed the Closure Device, and completed a sweep, TEE imaging showed no change in effusion. Approximately thirty minutes post deployment, the patient's blood pressure dropped. TEE imaging noted the effusion near the apex of the left ventricle. Physician performed a pericardiocentesis to treat the effusion, draining an unknown amount of dull colored fluid. Patient was stabilized and was admitted to intensive care unit. There were no further complications and approximately three days post procedure, the patient was discharged.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 50568660 ↗
• InjurySep 1, 2026Positioning Failure

  During a left atrial appendage closure (LAAC) procedure, a WATCHMAN TruSteer Access System, a 27 mm WATCHMAN FLX Pro LAA Closure Device and Delivery System, and a VersaCross Connect LAAC Access Solution were selected for use. A transseptal puncture was attempted using the VersaCross Connect System with the TruSteer sheath; however, multiple attempts to position the system on the fossa ovalis were unsuccessful, and transesophageal echocardiography (TEE) did not adequately demonstrate septal tenting in either the bicaval or short-axis views. During a subsequent repositioning attempt, the patient developed asystole, and transvenous pacing wires were placed via femoral access to manage the arrhythmia. The physician indicated that inadvertent contact with the atrioventricular (AV) node during positioning attempts may have contributed to the event. No malfunction was observed with the VersaCross device during the procedure, and while the patient had a medical history of permanent atrial fibrillation, it could not be determined whether the arrhythmia was related to this pre-existing condition. No information was available regarding medication administration. The patient recovered appropri

  Patient problems: Arrhythmia; Asystole

  MAUDE report 50546471 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that cardiac perforation, pericardial effusion and hypotension occurred. A pulse field ablation procedure was attempted using a FARADRIVE steerable sheath, VersaCross Connect RF Wire, and VersaCross Connect Dilator. The FARADRIVE steerable sheath was advanced into the patient anatomy, and the Intracardiac echocardiography (ICE) was inserted into the right atrium without any complications. The VersaCross Connect Dilator and VersaCross Connect RF Wire were inserted into the Faradrive sheath and into the right atrium. Transeptal access was gained using the VersaCross RF wire and the physician noticed odd looking tissue at the sight of Transeptal puncture and was unable to cross the FARADRIVE sheath and VersaCross dilator into the left atrium. The VersaCross RF wire, VersaCross dilator and FARADRIVE sheath were withdrawn into the right atrium, and a second Transeptal puncture was performed. Shortly after the second transseptal puncture, the patient became hypotensive and a pericardial effusion and cardiac perforation were identified. The physician performed a pericardiocentesis and the patient was extubated and hospitalized beyond the standard of care.

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

  MAUDE report 50545150 ↗

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