WATCHMANRecalls & reported problems across all models

We found 25 models of WATCHMAN by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 8,024 adverse event reports in the FDA's MAUDE database, received between Nov 15, 2016 and Sep 30, 2026 — classified as 580 deaths, 6,829 injuries, 615 malfunctions.

The most frequently reported specific device problem is “Migration” (492 reports).

6 FDA recall records name at least one of these models by its device identifier, 6 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 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-2436-2025 · 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-2435-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. 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 ↗

4. 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-2433-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

5. 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-2432-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

6. 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-2431-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported WATCHMAN problems

WATCHMAN models

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

• WATCHMAN FLX™ M635WU50270

  System, appendage closure, left atrial
  43 deaths731 reports
• WATCHMAN FXD Curve™ Access System M635TU80020

  Catheter, percutaneous
  1 recall47 deaths654 reports
• WATCHMAN® Access System M635TU20060

  System, appendage closure, left atrial
  27 deaths634 reports
• WATCHMAN FLX™ M635WU50240

  System, appendage closure, left atrial
  51 deaths606 reports
• WATCHMAN FLX™ Pro M635WU60270

  System, appendage closure, left atrial
  57 deaths596 reports
• WATCHMAN® M635WU27060

  System, appendage closure, left atrial
  45 deaths483 reports
• WATCHMAN FLX™ M635WU50310

  System, appendage closure, left atrial
  29 deaths458 reports
• WATCHMAN FLX™ Pro M635WU60310

  System, appendage closure, left atrial
  46 deaths452 reports
• WATCHMAN FLX™ Pro M635WU60240

  System, appendage closure, left atrial
  48 deaths429 reports
• WATCHMAN® M635WU24060

  System, appendage closure, left atrial
  26 deaths420 reports
• WATCHMAN TruSteer™ Access System M635TU90050

  Catheter, percutaneous
  1 recall28 deaths302 reports
• WATCHMAN® M635WU30060

  System, appendage closure, left atrial
  8 deaths295 reports
• WATCHMAN® M635WU33060

  System, appendage closure, left atrial
  16 deaths269 reports
• WATCHMAN™ TruSeal™ Access System M635TU70020

  Catheter, percutaneous
  1 recall11 deaths217 reports
• WATCHMAN FLX™ M635WU50200

  System, appendage closure, left atrial
  18 deaths254 reports
• WATCHMAN FLX™ Pro M635WU60350

  System, appendage closure, left atrial
  29 deaths250 reports
• WATCHMAN FLX™ M635WU50350

  System, appendage closure, left atrial
  12 deaths231 reports
• WATCHMAN® M635WU21060

  System, appendage closure, left atrial
  11 deaths219 reports
• WATCHMAN FLX™ Pro M635WU60200

  System, appendage closure, left atrial
  10 deaths147 reports
• WATCHMAN® Access System M635TU40060

  System, appendage closure, left atrial
  4 deaths111 reports
• WATCHMAN FLX™ Pro M635WU60400

  System, appendage closure, left atrial
  10 deaths104 reports
• WATCHMAN™ TruSeal™ Access System M635TU70040

  Catheter, percutaneous
  1 recall1 death50 reports
• WATCHMAN FXD Curve™ Access System M635TU80010

  Catheter, percutaneous
  1 recall1 death31 reports
• WATCHMAN™ TruSeal™ Access System M635TU70010

  Catheter, percutaneous
  1 recall21 reports
• WATCHMAN® Access System M635TU10060

  System, appendage closure, left atrial
  2 deaths60 reports

Recent WATCHMAN adverse event reports

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

• DeathSep 30, 2026Device Dislodged or Dislocated

  REPORTED VIA LITERATURE ARTICLEIt was reported that death occurred.A 67-year-old man underwent successful transfemoral left atrial appendage occlusion (LAAO) with a 31mm WATCHMAN FLX Closure Device with transesophageal echocardiography (TEE) guidance. Multiple angles were used to evaluate the left atrial appendage (LAA) dimensions, with the widest ostium measured at 22 mm. The implant satisfied manufacturer Position, Anchor, Size, and Seal (PASS) criteria. Immediate post implant TEE confirmed appropriate closure device position, stable anchoring, adequate seal, and closure device compression of 19 to 29 percent with no peri device leak on color Doppler assessment. No procedural complications occurred, and the patient was observed overnight, as per institutional protocol. The patient was discharged on dual antiplatelet therapy and instructed to avoid strenuous activity for two (2) weeks. Eighteen days later, while shoveling snow, the patient developed sudden-onset chest and back pain followed by bilateral lower extremity paralysis. Computed tomography (CT) revealed complete mid abdominal aortic occlusion from embolization of the LAAO closure device. Using a non-Boston Scientific (BS

  Patient problems: Abdominal Pain; Back pain; Chest Pain; Dizziness; Encephalopathy; Hematoma; High Blood Pressure/ Hypertension; Ischemia; Low Blood Pressure/ Hypotension; Mitral Valve Insufficiency/ Regurgitation; Muscle Weakness/Atrophy; Numbness; Paralysis; Renal Failure; Spinal Cord Injury; Thrombosis/Thrombus

  MAUDE report 50951585 ↗
• InjurySep 30, 2026Difficult to Remove

  Patient problems: Cardiac Perforation; Pericardial Effusion; Unspecified Tissue Injury

  MAUDE report 50951307 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported a pericardial effusion and cardiac tamponade occurred.A left atrial appendage closure (LAAC) procedure was performed, and a 20mm WATCHMAN FLX Pro LAA Closure Device was successfully implanted. Approximately five hours post procedure, the patient was experiencing unknown symptoms. A pericardial effusion with tamponade was noted. A pericardiocentesis was performed, removing an unknown amount of fluid from the patient.

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

  MAUDE report 50950744 ↗
• MalfunctionSep 30, 2026Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949833 ↗
• DeathSep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported a stroke and patient death occurred. A left atrial appendage (LAA) closure procedure was performed, and a 35mm WATCHMAN FLX Pro Closure Device was implanted. Immediately following the procedure, the patient exhibited right-sided weakness, inability to awaken, absence of speech attempts, inability to follow commands, and dysconjugate gaze. The patient was subsequently diagnosed with a stroke and was admitted to the hospital. In response to the stroke, thrombectomy was performed in Interventional Radiology to remove the clot and mechanical ventilation were performed. Four days following the index procedure, the patient died. The reported cause of death was thrombosis of the left middle cerebral artery (MCA) with a large left MCA infarct and significant cerebral edema resulting in a 1.8 cm left-to-right midline shift. The physician believed that a combination of preexisting comorbidities and the concomitant procedure led to the stroke.

  Patient problems: Loss of consciousness; Muscle Weakness/Atrophy; Speech Disorder; Stroke/CVA; Thromboembolism; Visual Disturbances

  MAUDE report 50945914 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Abdominal Pain; Speech Disorder; Unspecified Respiratory Problem

  MAUDE report 50937080 ↗
• InjurySep 29, 2026Failure to Seal

  REPORTED VIA CLINICAL STUDYIt was reported that the device did not seal. A left atrial appendage (LAA) closure procedure was performed as part of a clinical study, and a 31mm WATCHMAN FLX Pro Closure Device was implanted on (b)(6) 2025. The patient was discharged. The patient had a routine 12 month follow up, and computed tomography (CT) imaging showed a 7mm leak was present. No intervention or treatment was performed or planned.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934465 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that pericardial effusion occurred. A left atrial appendage closure (LAAC) procedure was performed. A 20mm WATCHMAN FLX Pro LAA Closure Device was successfully implanted on (b)(6) 2026. The patient was noted to have a small appendage, but the physician was able proceeded with the procedure. There were no recaptures or repositions performed and there were no issues reported with the transeptal puncture. The patient was discharged. The patient was seen in the emergency department on (b)(6) 2026, due to shortness of breath and general weakness. Pericardial effusion was reported and the patient was hospitalized. Pericardiocentesis was completed on (b)(6) 2026, and 500cc of red fluid was drained. The patient was stable following the procedure and discharged the next day.

  Patient problems: Dyspnea; Muscle Weakness/Atrophy; Pericardial Effusion

  MAUDE report 50934193 ↗
• DeathSep 29, 2026Adverse Event Without Identified Device or Use Problem

  REPORTED VIA CLINICAL STUDY.It was reported that death occurred.A left atrial appendage (LAA) closure procedure was performed, and a 27mm WATCHMAN FLX Closure Device was implanted on (b)(6) 2021. The patient was discharged. On (b)(6) 2026, the patient passed away due to ongoing issues with malignancy. Per investigator, the causality to the study device is noted as not related. However, per sponsor, the causality of the study device has been assessed as possible as per the conventions. It was further reported that the cause of death is unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932951 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Muscle Weakness/Atrophy; Speech Disorder; Stroke/CVA; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 50932546 ↗
• 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 29, 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. A WATCHMAN TruSteer Access System (WAS) and a 24mm WATCHMAN FLX Pro LAA Closure Device and Delivery System (WDS) were selected for use. During the transeptal puncture (TSP) the landing zone was low and posterior. The physician did not cross at that position. The physician then came to a mid/mid location and crossed the septum there. The pigtail wire did not advance in its normal shape. The wire was retracted back into the dilator, and the wire was readvanced into the LA where it then took its normal curl. The TruSteer sheath was then advanced into the LA and an angiography was completed to compare preprocedural measurements. The 24mm device was prepped and advanced in the WDS. The physician deployed the device, but it landed proximally. A full recapture was completed. Upon repositioning the device, fluid was noted behind the appendage. Transesophageal echocardiography (TEE) was used to sweep for effusion. An effusion appeared close to the right side of the heart and was dark in appearance. The device was fully recaptured. Another angiography was completed of the

  Patient problems: Pericardial Effusion

  MAUDE report 50931466 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50924318 ↗
• InjurySep 28, 2026Premature Separation

  It was reported that premature core wire detachment occurred. A left atrial appendage closure (LAAC) procedure was being performed. A WATCHMAN Access System (WAS) and a 24mm WATCHMAN FLX Pro LAA Closure (LAAC) Device and Delivery System was selected for use. The device appeared attached when going up the sheath, but when the tug test was done it was noted that the device had become unscrewed from the core wire. The device was left in place as it met all of the position, anchor, size and seal (PASS) criteria. The patient was reported to be in stable condition and has since been released.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915809 ↗
• MalfunctionSep 28, 2026Deformation Due to Compressive Stress

  It was reported that device damage occurred.During a left atrial appendage (LAA) closure procedure using transesophageal echocardiography (TEE) guidance, a 35mm WATCHMAN FLX Pro Delivery System and Closure Device (WDS) and WATCHMAN TruSteer Access System (WAS) were used. The procedure was performed without incident, and the Closure Device was successfully released. Following release, the physician attempted to advance a wire through the WAS; however, the wire would not advance. The WAS was removed, and a kink was observed in the access sheath. It was reported that the sheath had been maintained in the neutral position while withdrawing to the right side of the heart and that no excessive force was used during the procedure. The WAS was removed, and the groin access site was closed. The procedure was completed as planned, and the patient remained stable with no additional problems reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915803 ↗

Other Boston Scientific Corporation products

• INGEVITY MRI7 models · 16,601 reports
• INGEVITY+3 models · 16,054 reports
• EMBLEM S-ICD4 models · 13,295 reports · 1 recall
• AMS 800 Artificial Urinary Sphincter31 models · 7,515 reports · 2 recalls
• ENDOTAK RELIANCE SG9 models · 6,540 reports · 2 recalls
• RELIANCE 4-FRONT11 models · 5,739 reports
• FINELINE II EZ Sterox6 models · 5,633 reports
• ENDOTAK RELIANCE G12 models · 5,053 reports · 2 recalls