WATCHMAN FXD Curve Access SystemRecalls & reported problems across all models

We found 2 models of WATCHMAN FXD Curve Access System by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 685 adverse event reports in the FDA's MAUDE database, received between Feb 10, 2022 and Sep 30, 2026 — classified as 48 deaths, 582 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (33 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 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

WATCHMAN FXD Curve Access System 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. Jul 29, 2025Open, Classified

   Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.

   Z-2435-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Jul 29, 2025Open, Classified

   Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.

   Z-2434-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported WATCHMAN FXD Curve Access System problems

WATCHMAN FXD Curve Access System models

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

• WATCHMAN FXD Curve™ Access System M635TU80020

  Catheter, percutaneous
  1 recall47 deaths654 reports
• WATCHMAN FXD Curve™ Access System M635TU80010

  Catheter, percutaneous
  1 recall1 death31 reports

Recent WATCHMAN FXD Curve Access System adverse event reports

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

• MalfunctionSep 30, 2026Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949833 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported thrombosis occurred. A left atrial appendage closure (LAAC) procedure was being performed. A WATCHMAN FXD Double Curve Access System (WAS) and a 24mm WATCHMAN FLX Pro LAA Closure Device and Delivery System (WDS) was selected for use. Transseptal puncture was successfully completed, and the activated clotting time (ACT) was 373 seconds. The WAS was inserted, and a 24mm WDS was advanced and deployed. After assessment, the 24mm WDS was determined to be undersized. The device was recaptured, removed, and exchanged for a larger 27mm WDS. As the 27 mm WDS was introduced through the WAS, transesophageal echocardiography (TEE) revealed a long, fibrous clot within the left atrial appendage. The 27mm WDS was removed from the sheath, and the physician aspirated 30mL of blood through the WAS. Following aspiration, the clot was no longer visualized on TEE; however, no clot was identified in the aspirated blood. The physician then reintroduced and began advancing the same WDS. As the device approached the tip of the WAS sheath, the same fibrous clot was again observed on TEE. The device was removed, and aspiration was repeated, this time with 50mL of blood. The clot again disappe

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50932308 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 50824656 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that asystole occurred.A left atrial appendage (LAA) closure procedure was being performed under intracardiac echocardiography (ICE) and transesophageal echocardiography (TEE) guidance using a WATCHMAN FXD Double Curve Access System (WAS) and VersaCross Connect. While the physician was coming down from the superior vena cava in preparation for transseptal puncture with both devices, the patient developed asystole lasting approximately 20 to 30 seconds. External pacing was initiated, and the patient subsequently returned to atrial fibrillation. Imaging confirmed no pericardial effusion, and the physician elected to proceed with the procedure. Prior to WATCHMAN Closure Device implantation, cardioversion was attempted but was unsuccessful in restoring sinus rhythm. The procedure was completed as planned. The patient remained stable with no further reported complications. The patient was discharged the same day.

  Patient problems: Asystole

  MAUDE report 50805549 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that air embolism and ST segment elevation occurred.A left atrial appendage (LAA) closure procedure was performed, and a WATCHMAN FXD Curve Access System (WAS) was selected to be used. During the procedure the physician performed pre-imaging to see the size and morphology of the appendage as well as evaluate for baseline effusion, which there was no effusion during this procedure. The physician gets access in the right femoral vein, using a non-Boston Scientific (BSC) micropuncture kit and a standard J-wire. After gaining access, the physician inserted the non-BSC Fast-Cath sheath over a standard non-BSC J-wire. Once the sheath and J-wire were advanced into the superior vena cava (SVC), the physician removed the standard non-BSC J-wire, inserted the non-BSC BRK needle, and began the process of crossing the septum to access the left atrium. Using transesophageal echocardiography (TEE), the physician assessed the position on the septum to confirm appropriate tenting and access location. The physician punctured the inferior-mid portion of the septum with the non-BSC BRK needle. After crossing the septum, the physician advanced the non-BSC Fast-Cath sheath into the left

  Patient problems: Air Embolism; Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes

  MAUDE report 50777886 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported a pericardial effusion occurred. A left atrial appendage closure (LAAC) procedure was being performed. A WATCHMAN FXD Curve Access System (WAS) and a WATCHMAN LAA Closure Device & Delivery System (WDS) was selected for use. The initial transeptal puncture (TSP) was performed using VersaCross. While attempting to cross the interatrial septum with Intracardiac Echo (ICE) imaging, an effusion was noted. A Transesophageal Echocardiography (TEE) imaging probe was placed in the patient to monitor the effusion while the physician proceeded with the WATCHMAN implant procedure. There was no intervention required. The Closure Device was implanted in the LAA. The patient stayed in the hospital overnight for observation and discharged the following day with no further complications reported.

  Patient problems: Pericardial Effusion

  MAUDE report 50735304 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that pericardial effusion and cardiac tamponade occurred.A left atrial appendage (LAA) closure procedure was being performed, and a WATCHMAN FXD Curve Access System (WAS) was selected to be used. During the procedure, access was obtained via the groin for the WAS sheath and an additional sheath for intra cardiac echocardiography (ICE). VersaCross Connect was used in conjunction with ICE to cross the atrial septum at an inferior-mid location. The wire crossed the septum, and position was confirmed by ICE without issue. The WAS sheath was advanced and retracted to dilate septal puncture. The ICE catheter was advanced across the septum uneventfully and measurements of the LAA were obtained. The WAS sheath was advanced to the left atrium, a pigtail catheter was inserted and an angiogram was performed. The patient's blood pressure was low, so an effusion sweep was performed with ICE, and a large pericardial effusion was noted on the right ventricle (RV) free wall. The patient's chest was prepped and pericardiocentesis was performed. A total of 400cc of bright red blood was aspirated, and the patient required one (1) unit of blood transfusion. The sheaths were removed and

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

  MAUDE report 50671278 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50600742 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  It was reported a cardiac perforation and pericardial effusion occurred. A left atrial appendage (LAA) closure procedure was being performed. A WATCHMAN FXD Curve Access System (WAS) and a WATCHMAN LAA Closure Device & Delivery System (WDS) were selected for use. During the initial transeptal puncture (TSP) using the WAS and VersaCross Connect system, Intracardiac Echo (ICE) was difficult to visualize the left atrium (LA). The VersaCross Connect wire was tented, and while preparing to buzz across the left atrium (LA), it was noted the WATCHMAN FXD Curve sheath and dilator had not advanced over to the LA. The physician pulled back the wire to recross, noting again, the sheath and dilator had not advanced over the interatrial septum. At this time, it was noted the wire had perforated the aorta. Physician observed a small circumferential pericardial effusion, noting it was not large enough to drain/treat. Transesophageal echocardiography (TEE) and computed tomography (CT) imaging was also completed as part of the assessment. The patient had stable blood pressure, and the implant procedure was discontinued. The patient remained in the hospital for three days. There were no further comp

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 50548864 ↗
• MalfunctionAug 20, 2026Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  It was reported that a kink occurred, and the procedure was cancelled.A left atrial appendage (LAA) closure procedure was being performed, and a WATCHMAN FXD Curve Access System (WAS) was selected to be used. The patient was sedated with general anesthesia. During the procedure, transeptal puncture (TSP) was performed in an inferior/posterior location and the physician approached using a WAS. An attempt was made to deploy the 40mm closure device; however, interference from the posterior pectinate caused the closure device to pop out, resulting in significant protrusion. The WAS sheath was severely bent and replacing it was unlikely to resolve the issue. Furthermore, due to insufficient space to select an alternative TSP site, the procedure was discontinued at the physician's discretion.It was further reported that there was no report that the WATCHMAN Access System was kinked and that the report does not indicate that the 40mm Closure Device and Delivery System was bent. It was reported that the sheath was on a severely angulated trajectory, and changing the sheath was not expected to resolve the issue. Therefore, the complaint will be considered non-reportable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50358895 ↗
• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that thrombosis occurred.A left atrial appendage (LAA) closure procedure was being performed. A WATCHMAN FXD Curve Access System (WAS) and a WATCHMAN FLX LAA Closure Device & Delivery System (WDS) were selected to be used. The physician inserted the WAS and positioned the device in the LAA of the patient. The WDS was prepared and ready to be inserted when a thrombus was noted adhering to the pigtail catheter upon its removal from the left atrial appendage. The physician administered an additional 7,000 units of heparin and then continued the procedure. The procedure was then successfully completed with the closure device implanted in the LAA of the patient. There were no other complications that were reported to have occurred as a result of this event.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50288795 ↗
• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported a pericardial effusion occurred.A left atrial appendage closure (LAAC) procedure was being performed. It was noted that the patient had a small baseline pericardial effusion prior to the procedure. A WATCHMAN FXD Double Curve Access System (WAS) and a WATCHMAN FLX Pro LAA Closure Device and Delivery System (WDS) was selected for use. Vascular access was obtained via the groin, and a VersaCross Connect system was utilized to perform the transseptal puncture (TSP). After several attempts, transseptal access was successfully achieved in a mid/mid position. At this time, the patient developed cardiac tamponade, and a circumferential pericardial effusion surrounding the right atrium and right ventricle began to develop. The procedure was cancelled and pericardiocentesis with a pericardial window was performed. Approximately 1 to 2 liters of fluid was drained and transfused back to the patient. The patient remained hospitalized for recovery but has since been discharged.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 50288752 ↗
• MalfunctionAug 14, 2026Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50255875 ↗
• InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50244650 ↗
• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that pericardial effusion occurred. A left atrial appendage closure (LAAC) procedure was being performed. The physician was attempting to go transeptal and noticed a small pericardial effusion. The physician had slipped into the coronary sinus with the pigtail catheter. The patient was given protamine and the effusion remained stable. The procedure was discontinued. The patient was monitored and will have follow up echocardiography imaging to evaluate for effusion.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 50229887 ↗

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