WATCHMAN FLX™ M635WU50310Recalls & reported problems

Summary

The FDA's MAUDE database contains 458 adverse event reports that list this exact device (DI 08714729860518), received between Sep 14, 2020 and Sep 30, 2026 — classified as 29 deaths, 407 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Migration” (44 reports).

2 other recalls cover devices cleared under the same FDA submission (P130013); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 458 reports, 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 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 15, 2026Adverse Event Without Identified Device or Use Problem; Failure to Seal

  Patient problems: Fall; Stroke/CVA

  MAUDE report 50780271 ↗
• InjurySep 1, 2026Failure to Seal

  REPORTED VIA CLINICAL STUDY.It was reported an implant did not seal.A left atrial appendage (LAA) closure procedure was performed, and a 31mm WATCHMAN FLX LAA Closure Device was implanted on (b)(6) 2022. The patient was discharged. On June 9, 2026, during the patient follow-up surveillance computed tomography angiography (CTA) for dilated aortic root imaging, a 5.5mm peri device leak was suspected. Follow-up Transesophageal Echocardiography (TEE) imaging confirmed a 3mm leak. As a result, the patient remains on their oral anticoagulant medication.

  Patient problems: Fall; No Clinical Signs, Symptoms or Conditions; Transient Ischemic Attack

  MAUDE report 50548861 ↗
• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported thrombosis occurred. A left atrial appendage (LAA) closure procedure was performed, and a 31mm WATCHMAN FLX Closure Device was implanted on (b)(6) 2024. The patient was subsequently discharged. A physician later reported to a Boston Scientific (BSC) Clinical Specialist that the patient presented to a different hospital from the implanting facility on (b)(6) 2026, with an altered mental status. A transesophageal echocardiogram (TEE) was performed and revealed the presence of a thrombus on the WATCHMAN FLX Closure Device. The patient was placed on a stroke protocol for further evaluation and management. The patient underwent a computed tomography angiography (CTA) of the head and neck, magnetic resonance imaging (MRI) of the brain, and a transesophageal echocardiogram (TEE) as part of the stroke evaluation. Findings were consistent with a Percheron artery stroke and hypertensive urgency. An MRI of the brain and brainstem without contrast performed on (b)(6) 2026, showed bilateral restricted diffusion within the thalami. The MRI also noted prior infarctions involving the cerebellum and both cerebral hemispheres. The patient had not been compliant with keeping follow up

  Patient problems: Cognitive Changes; High Blood Pressure/ Hypertension; Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 50310189 ↗
• DeathAug 13, 2026Adverse Event Without Identified Device or Use Problem

  REPORTED VIA CLINICAL STUDY:It was reported that patient death occurred. A left atrial appendage closure (LAAC) procedure was performed and a 31mm WATCHMAN FLX LAA Closure Device and Delivery System (WDS) was successfully implanted on (b)(6) 2022. The patient is reported to have passed away at home on (b)(6) 2026. A review of the obituary provided no additional information and no official cause of death was provided.It was further reported that the physician has assessed the relationship of the death and the implant as not related.It was further reported that the patient experienced cardiac arrest due to worsening acute kidney failure.It was further reported that as per the Sponsor, the causality of the study device WATCHMAN FLX LAA Closure Device has been downgraded to Not related as per the conventions. The complaint has been withdrawn.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50240105 ↗
• DeathMar 20, 2026Adverse Event Without Identified Device or Use Problem

  REPORTED VIA CLINICAL STUDY. IT WAS REPORTED THAT PATIENT DEATH OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. A 31MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED ON (B)(6) 2023, WITH COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 26.0 MM. THE PATIENT WAS DISCHARGED THE SAME DAY ON A MEDICATION REGIME OF ASPIRIN (81 MG/DAY) AND RIVAROXABAN (20 MG/DAY). ON (B)(6) 2025, 829 DAYS POST INDEX PROCEDURE, THE PATIENT WAS REPORTED TO HAVE PASSED AWAY. NO ADDITIONAL INFORMATION ON THE CAUSE OF DEATH WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650603 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  REPORTED VIA PATIENT CALL CENTER. IT WAS REPORTED A CEREBRAL VASCULAR ACCIDENT (CVA) AND THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 31MM WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED. AT AN UNKNOWN DATE POST INDEX PROCEDURE, THE PATIENT REPORTED HAVING A CVA AND A THROMBUS WAS FOUND TO BE ATTACHED TO THE CLOSURE DEVICE. THE PHYSICIANS STARTED THE PATIENT ON ELIQUIS IN RESPONSE TO THE THROMBUS AND WILL HAVE THE PATIENT TAKE ANOTHER TEST IN THREE (3) MONTHS TO SEE IF THE THROMBUS HAS DISSOLVED.

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 24546027 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 31MM WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED ON (B)(6) 2022. IT WAS NOTED THAT THE IMPLANT HAD A SLIGHT GUTTER. THE PATIENT WAS DISCHARGED. AT A ROUTINE FOLLOW UP TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) 9-12 MONTHS POST IMPLANT, A DEVICE RELATED THROMBUS (DRT) WAS NOTED. THE PATIENT REMAINED ON ELIQUIS AT THE TIME BUT COULD NOT TOLERATE DUE TO BLEEDING SO THE DOSAGE WAS DECREASED. THE THROMBUS RESOLVED AND THE PATIENT WAS TAKEN OFF ELIQUIS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24532385 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 31MM WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED ON (B)(6) 2022. IT WAS NOTED THAT THE IMPLANT HAD A SLIGHT GUTTER. THE PATIENT WAS DISCHARGED. AT A ROUTINE FOLLOW UP TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE), A DEVICE RELATED THROMBUS (DRT) WAS NOTED. THE PATIENT REMAINED ON ELIQUIS AT THE TIME BUT COULD NOT TOLERATE DUE TO BLEEDING SO THE DOSAGE WAS DECREASED. THE THROMBUS RESOLVED AND THE PATIENT WAS TAKEN OFF ELIQUIS. IN (B)(6) 2026, THE PATIENT HAD ANOTHER ROUTINE FOLLOW UP TEE AND ANOTHER DRT WAS NOTED ON THE RIDGE SIDE OF THE DEVICE TOWARD THE LIMBUS. THE PATIENT WAS PLACED BACK ON HALF DOSE OF ELIQUIS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24532358 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 31MM WATCHMAN FLX CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED ON (B)(6) 2023. THE PATIENT WAS DISCHARGED. DURING AN UNKNOWN TIME, THE PATIENT HAD A TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE), AND THE PHYSICIAN NOTED A DEVICE RELATED THROMBUS NEAR THE THREADED INSERT. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24335090 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A DEVICE RELATED THROMBUS. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) AND A 31MM WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED TO BE USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE CLOSURE DEVICE IMPLANTED IN THE LAA OF THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS THAT WERE REPORTED TO HAVE OCCURRED. THE PATIENT WAS DISCHARGED ON A PLAVIX AND ASPIRIN MEDICATION REGIMENT. THE PATIENT CAME IN FOR THEIR 45 DAY FOLLOW UP IMAGING PROCEDURE. THE IMAGING SHOWED THAT THE CLOSURE DEVICE WAS WELL PLACED AND THERE WERE NO ISSUES. THREE (3) MONTHS LATER THE PATIENT HAD A COMPUTED TOMOGRAPHY SCAN ON THEIR KIDNEYS AND THE PHYSICIAN NOTED THAT THERE WAS A THROMBUS PRESENT ON THE CLOSURE DEVICE AT THIS TIME. THE PATIENT HAD THEIR SIX (6) MONTH FOLLOW UP TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) PROCEDURE. THE TEE IMAGING SHOWED THAT THE THROMBUS WAS STILL PRESENT ON THE CLOSURE DEVICE. THE PATIENT WAS THEN PLACED ON WARFARIN IN RESPONSE TO THIS EVENT. EIGHT (8) MONTHS POST PROCEDURE ANOTHER TEE WAS PERFORMED, AND A LARGE THROMBUS WAS STILL PRESENT ON THE CLOSURE DEVICE. THE PATIEN

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24292563 ↗
• InjuryJan 9, 2026Failure to Seal

  IT WAS REPORTED THE DEVICE DID NOT SEAL. A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE WAS PERFORMED. A WATCHMAN FXD DOUBLE CURVE ACCESS SYSTEM (WAS) AND A 31MM WATCHMAN FLX PRO LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WAS SELECTED FOR USE. THE 31MM CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED IN THE PATIENT ON (B)(6) 2023. THE PATIENT WAS DISCHARGED. ON (B)(6) 2025, DURING ROUTINE FOLLOW UP TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IMAGING, IT WAS NOTED THAT THE PATIENT HAD A PERI-DEVICE LEAK. THE PHYSICIAN PLANNED TO COIL THE LEAK. THE PATIENT DID NOT HAVE ANY SYMPTOMS OR MEDICAL CONCERNS PRIOR TO FINDING THE LEAK. ON (B)(6) 2025, A PRE-COILING TEE DEMONSTRATED A 3MM LEAK. THE PHYSICIAN PROCEEDED WITH COILING CONSIDERING THE LEAK WAS A NEW FINDING, THEREFORE ON (B)(6) 2025, THE PHYSICIAN PLACED COILS TO CLOSE THE LEAK. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS DISCHARGED THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24021207 ↗
• InjuryDec 5, 2025Failure to Seal; Failure to Seal

  REPORTED VIA CLINICAL STUDY IT WAS REPORTED CEREBRAL VASCULAR ACCIDENT (CVA) AND INCOMPLETE SEAL OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 31MM WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED WITH COMPLETE SEAL NOTED. THE PATIENT WAS DISCHARGED ON APIXABAN AND ASPIRIN. DURING THE FOUR (4) MONTH FOLLOW UP TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) PERFORMED ON (B)(6) 2022, IMAGING SHOWED INCOMPLETE LAA SEAL OF UNKNOWN JET SIZE. ON (B)(6) 2025, THE PATIENT PRESENTED TO THE HOSPITAL WITH A HIP FRACTURE FOLLOWING A GROUND-LEVEL FALL TWO (2) DAYS PRIOR AND ADMITTED TO THE HOSPITAL. ON (B)(6) 2025, LAB FINDINGS DEMONSTRATED HYPOTENSION AND MARKED LEUKOCYTOSIS. COMPUTED TOMOGRAPHY (CT) IMAGING OF THE ABDOMEN AND PELVIS REVEALED COLITIS, AND A SEVEN-DAY ANTIBIOTIC COURSE WAS INITIATED. THE EVENT WAS REPORTED AS SEPSIS. ON OCTOBER 21, 2025 (1,408 DAYS POST-INDEX PROCEDURE), THE PATIENT DEVELOPED A STROKE WHILE ON ASPIRIN THERAPY. CLOPIDOGREL WAS INITIATED IN RESPONSE. THE FOLLOWING DAY, THE PATIENT DEVELOPED FACIAL DROOP, AND A MAGNETIC RESONANCE IMAGING (MRI) OF THE BRAIN WAS PERFORMED WHICH REVEALED ISCHEMIC STROKE. ON (B)(6) 2025, THE HIP FRACTURE AND SEPSIS EVENT

  Patient problems: Abdominal Distention; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bone Fracture(s); Confusion/ Disorientation; Facial Paralysis; Fall; High White Blood Cell Count; Low Blood Pressure/ Hypotension; Sepsis; Stroke/CVA

  MAUDE report 23728381 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTED VIA PATIENT CALL CENTER: IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 31MM WATCHMAN FLX CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED ON (B)(6) 2022. THE PATIENT WAS DISCHARGED. AT AN UNKNOWN TIME, THE PATIENT HAD A PULSE FIELD ABLATION, AND A CLOT WAS NOTED IN THE TOP OF THE CLOSURE DEVICE. THE PATIENT STATED THEY WERE TOLD TO TAKE 5MG ELIQUIS TWICE A DAY TO TRY TO DISSOLVE THE CLOT. THE PATIENT WILL RETURN IN (B)(6) 2026 TO DETERMINE IF THE EVENT HAS BEEN RESOLVED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23543355 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE WAS PERFORMED AND A 31MM WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED. AT THE ONE (1) YEAR ROUTINE FOLLOW UP PERFORMED 403 DAYS POST INDEX PROCEDURE, TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IMAGING REVEALED A SMALL DEVICE RELATED THROMBUS (DRT) LOCATED ON THE FACE OF THE CLOSURE DEVICE. NO MEDICAL INTERVENTION WAS PERFORMED. THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23368448 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT SUMMARIZES 1 SERIOUS INJURY EVENT FOR SURGICAL INTERVENTION. NOTE THAT MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT BUT ARE CAPTURED SEPARATELY UNDER REPORTING GUIDELINES. DEVICE RELATIONSHIP TO THE EVENTS REPORTED IS NOT PROVIDED. TYPE OF PROCEDURE: LEFT ATRIAL APPENDAGE CLOSURE. BOSTON SCIENTIFIC RECEIVED NOTIFICATION OF EVENTS FOR THE WATCHMAN LAAC DEVICE REPORTED IN THE LEFT ATRIAL APPENDAGE OCCLUSION REGISTRY (LAAO) REGISTRY, WATCHMAN SURPASS CLINICAL STUDY TO ASSESS LONG-TERM SAFETY AND EFFECTIVENESS OUTCOMES ASSOCIATED WITH THE USE AND IMPLANTATION OF THE WATCHMAN FLX LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICE WITH DELIVERY SYSTEM IN A ROUTINE CLINICAL SETTING. PATIENT EVENTS WERE REPORTED AS EVENT TERMS WITH NO FURTHER DETAILED INFORMATION. MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT BUT ARE CAPTURED SEPARATELY UNDER THE TERMS OF THE SUMMARY REPORTING GUIDELINES. DATA INCLUDES NEWLY IMPLANTED PATIENTS AND FOLLOW UP OF PATIENTS INCLUDED IN THE PREVIOUS DATA SET. UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, DATA IS ANONYMIZED BEFORE BEING TRANSMITTED TO BSC, THUS THERE ARE SIGNIFICANT LIMITATIONS TO BSC'S ABILITY TO CORRELATE THE DATA TO INFORMATIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587769 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT SUMMARIZES 1 SERIOUS INJURY EVENT FOR THROMBOEMBOLISM. NOTE THAT MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT BUT ARE CAPTURED SEPARATELY UNDER REPORTING GUIDELINES. DEVICE RELATIONSHIP TO THE EVENTS REPORTED IS NOT PROVIDED. TYPE OF PROCEDURE: LEFT ATRIAL APPENDAGE CLOSURE BOSTON SCIENTIFIC RECEIVED NOTIFICATION OF EVENTS FOR THE WATCHMAN LAAC DEVICE REPORTED IN THE LEFT ATRIAL APPENDAGE OCCLUSION REGISTRY (LAAO) REGISTRY, WATCHMAN SURPASS CLINICAL STUDY TO ASSESS LONG-TERM SAFETY AND EFFECTIVENESS OUTCOMES ASSOCIATED WITH THE USE AND IMPLANTATION OF THE WATCHMAN FLX LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICE WITH DELIVERY SYSTEM IN A ROUTINE CLINICAL SETTING. PATIENT EVENTS WERE REPORTED AS EVENT TERMS WITH NO FURTHER DETAILED INFORMATION. MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT BUT ARE CAPTURED SEPARATELY UNDER THE TERMS OF THE SUMMARY REPORTING GUIDELINES. DATA INCLUDES NEWLY IMPLANTED PATIENTS AND FOLLOW UP OF PATIENTS INCLUDED IN THE PREVIOUS DATA SET. UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, DATA IS ANONYMIZED BEFORE BEING TRANSMITTED TO BSC, THUS THERE ARE SIGNIFICANT LIMITATIONS TO BSC'S ABILITY TO CORRELATE THE DATA TO INFORMATION PREVI

  Patient problems: Thromboembolism

  MAUDE report 22587724 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT SUMMARIZES 10 SERIOUS INJURY EVENTS FOR THROMBOSIS. NOTE THAT MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT BUT ARE CAPTURED SEPARATELY UNDER REPORTING GUIDELINES. DEVICE RELATIONSHIP TO THE EVENTS REPORTED IS NOT PROVIDED. OF THE REPORTED 10 SERIOUS INJURY THROMBOSIS EVENTS: 3 WERE LATE DEVICE THROMBOSIS (30 DAYS - 1 YEAR POST IMPLANT). 7 WERE A VERY LATE DEVICE THROMBOSIS (MORE THAN 1 YEAR POST IMPLANT). AGE RANGE: 67 TO 88 YEARS. PATIENT SEX: 5 FEMALES; 5 MALES. TYPE OF PROCEDURE: LEFT ATRIAL APPENDAGE CLOSURE. BOSTON SCIENTIFIC RECEIVED NOTIFICATION OF EVENTS FOR THE WATCHMAN LAAC DEVICE REPORTED IN THE LEFT ATRIAL APPENDAGE OCCLUSION REGISTRY (LAAO) REGISTRY, WATCHMAN SURPASS CLINICAL STUDY TO ASSESS LONG-TERM SAFETY AND EFFECTIVENESS OUTCOMES ASSOCIATED WITH THE USE AND IMPLANTATION OF THE WATCHMAN FLX LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICE WITH DELIVERY SYSTEM IN A ROUTINE CLINICAL SETTING. PATIENT EVENTS WERE REPORTED AS EVENT TERMS WITH NO FURTHER DETAILED INFORMATION. MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT BUT ARE CAPTURED SEPARATELY UNDER THE TERMS OF THE SUMMARY REPORTING GUIDELINES. DATA INCLUDES NEWLY IMPLANTED PATIENTS AND FOLLOW UP O

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22587717 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT SUMMARIZES 7 SERIOUS INJURY EVENTS FOR UNEXPECTED MEDICAL INTERVENTION. NOTE THAT MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT BUT ARE CAPTURED SEPARATELY UNDER REPORTING GUIDELINES. DEVICE RELATIONSHIP TO THE EVENTS REPORTED IS NOT PROVIDED. AGE RANGE: 63 TO 85 YEARS. PATIENT SEX: 7 MALES. TYPE OF PROCEDURE: LEFT ATRIAL APPENDAGE CLOSURE. BOSTON SCIENTIFIC RECEIVED NOTIFICATION OF EVENTS FOR THE WATCHMAN LAAC DEVICE REPORTED IN THE LEFT ATRIAL APPENDAGE OCCLUSION REGISTRY (LAAO) REGISTRY, WATCHMAN SURPASS CLINICAL STUDY TO ASSESS LONG-TERM SAFETY AND EFFECTIVENESS OUTCOMES ASSOCIATED WITH THE USE AND IMPLANTATION OF THE WATCHMAN FLX LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICE WITH DELIVERY SYSTEM IN A ROUTINE CLINICAL SETTING. PATIENT EVENTS WERE REPORTED AS EVENT TERMS WITH NO FURTHER DETAILED INFORMATION. MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT BUT ARE CAPTURED SEPARATELY UNDER THE TERMS OF THE SUMMARY REPORTING GUIDELINES. DATA INCLUDES NEWLY IMPLANTED PATIENTS AND FOLLOW UP OF PATIENTS INCLUDED IN THE PREVIOUS DATA SET. UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, DATA IS ANONYMIZED BEFORE BEING TRANSMITTED TO BSC, THUS THERE ARE SIGNIFICANT LIMI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587673 ↗
• DeathJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT SUMMARIZES 6 DEATH EVENTS FOR CEREBRAL VASCULAR ACCIDENT (CVA). NOTE THAT MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT BUT ARE CAPTURED SEPARATELY UNDER REPORTING GUIDELINES. DEVICE RELATIONSHIP TO THE EVENTS REPORTED IS NOT PROVIDED. AGE RANGE: 61 TO 87 YEARS. PATIENT SEX: 3 FEMALE; 3 MALE. TYPE OF PROCEDURE: LEFT ATRIAL APPENDAGE CLOSURE. BOSTON SCIENTIFIC RECEIVED NOTIFICATION OF EVENTS FOR THE WATCHMAN LAAC DEVICE REPORTED IN THE LEFT ATRIAL APPENDAGE OCCLUSION REGISTRY (LAAO) REGISTRY, WATCHMAN SURPASS CLINICAL STUDY TO ASSESS LONG-TERM SAFETY AND EFFECTIVENESS OUTCOMES ASSOCIATED WITH THE USE AND IMPLANTATION OF THE WATCHMAN FLX LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICE WITH DELIVERY SYSTEM IN A ROUTINE CLINICAL SETTING. PATIENT EVENTS WERE REPORTED AS EVENT TERMS WITH NO FURTHER DETAILED INFORMATION. MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT BUT ARE CAPTURED SEPARATELY UNDER THE TERMS OF THE SUMMARY REPORTING GUIDELINES. DATA INCLUDES NEWLY IMPLANTED PATIENTS AND FOLLOW UP OF PATIENTS INCLUDED IN THE PREVIOUS DATA SET. UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, DATA IS ANONYMIZED BEFORE BEING TRANSMITTED TO BSC, THUS THERE ARE SIGNIFICANT LIM

  Patient problems: Stroke/CVA

  MAUDE report 22587671 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT SUMMARIZES 1 SERIOUS INJURY EVENT FOR DEVICE EXPLANTATION. NOTE THAT MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT BUT ARE CAPTURED SEPARATELY UNDER REPORTING GUIDELINES. DEVICE RELATIONSHIP TO THE EVENTS REPORTED IS NOT PROVIDED. TYPE OF PROCEDURE: LEFT ATRIAL APPENDAGE CLOSURE. BOSTON SCIENTIFIC RECEIVED NOTIFICATION OF EVENTS FOR THE WATCHMAN LAAC DEVICE REPORTED IN THE LEFT ATRIAL APPENDAGE OCCLUSION REGISTRY (LAAO) REGISTRY, WATCHMAN SURPASS CLINICAL STUDY TO ASSESS LONG-TERM SAFETY AND EFFECTIVENESS OUTCOMES ASSOCIATED WITH THE USE AND IMPLANTATION OF THE WATCHMAN FLX LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICE WITH DELIVERY SYSTEM IN A ROUTINE CLINICAL SETTING. PATIENT EVENTS WERE REPORTED AS EVENT TERMS WITH NO FURTHER DETAILED INFORMATION. MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT BUT ARE CAPTURED SEPARATELY UNDER THE TERMS OF THE SUMMARY REPORTING GUIDELINES. DATA INCLUDES NEWLY IMPLANTED PATIENTS AND FOLLOW UP OF PATIENTS INCLUDED IN THE PREVIOUS DATA SET. UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, DATA IS ANONYMIZED BEFORE BEING TRANSMITTED TO BSC, THUS THERE ARE SIGNIFICANT LIMITATIONS TO BSC'S ABILITY TO CORRELATE THE DATA TO INFORMATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587608 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT SUMMARIZES 9 SERIOUS INJURY EVENTS FOR TRANSIENT ISCHEMIC ATTACK (TIA). NOTE THAT MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT BUT ARE CAPTURED SEPARATELY UNDER REPORTING GUIDELINES. DEVICE RELATIONSHIP TO THE EVENTS REPORTED IS NOT PROVIDED. AGE RANGE: 69 TO 86 YEARS. PATIENT SEX: 2 FEMALES; 7 MALE. TYPE OF PROCEDURE: LEFT ATRIAL APPENDAGE CLOSURE. BOSTON SCIENTIFIC RECEIVED NOTIFICATION OF EVENTS FOR THE WATCHMAN LAAC DEVICE REPORTED IN THE LEFT ATRIAL APPENDAGE OCCLUSION REGISTRY (LAAO) REGISTRY, WATCHMAN SURPASS CLINICAL STUDY TO ASSESS LONG-TERM SAFETY AND EFFECTIVENESS OUTCOMES ASSOCIATED WITH THE USE AND IMPLANTATION OF THE WATCHMAN FLX LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICE WITH DELIVERY SYSTEM IN A ROUTINE CLINICAL SETTING. PATIENT EVENTS WERE REPORTED AS EVENT TERMS WITH NO FURTHER DETAILED INFORMATION. MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT BUT ARE CAPTURED SEPARATELY UNDER THE TERMS OF THE SUMMARY REPORTING GUIDELINES. DATA INCLUDES NEWLY IMPLANTED PATIENTS AND FOLLOW UP OF PATIENTS INCLUDED IN THE PREVIOUS DATA SET. UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, DATA IS ANONYMIZED BEFORE BEING TRANSMITTED TO BSC, THUS THERE ARE SIGNIF

  Patient problems: Transient Ischemic Attack

  MAUDE report 22587514 ↗
• DeathJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT SUMMARIZES 1 DEATH EVENT FOR UNSPECIFIED INFECTION. NOTE THAT MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT BUT ARE CAPTURED SEPARATELY UNDER REPORTING GUIDELINES. DEVICE RELATIONSHIP TO THE EVENTS REPORTED IS NOT PROVIDED. TYPE OF PROCEDURE: LEFT ATRIAL APPENDAGE CLOSURE. BOSTON SCIENTIFIC RECEIVED NOTIFICATION OF EVENTS FOR THE WATCHMAN LAAC DEVICE REPORTED IN THE LEFT ATRIAL APPENDAGE OCCLUSION REGISTRY (LAAO) REGISTRY, WATCHMAN SURPASS CLINICAL STUDY TO ASSESS LONG-TERM SAFETY AND EFFECTIVENESS OUTCOMES ASSOCIATED WITH THE USE AND IMPLANTATION OF THE WATCHMAN FLX LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICE WITH DELIVERY SYSTEM IN A ROUTINE CLINICAL SETTING. PATIENT EVENTS WERE REPORTED AS EVENT TERMS WITH NO FURTHER DETAILED INFORMATION. MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT BUT ARE CAPTURED SEPARATELY UNDER THE TERMS OF THE SUMMARY REPORTING GUIDELINES. DATA INCLUDES NEWLY IMPLANTED PATIENTS AND FOLLOW UP OF PATIENTS INCLUDED IN THE PREVIOUS DATA SET. UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, DATA IS ANONYMIZED BEFORE BEING TRANSMITTED TO BSC, THUS THERE ARE SIGNIFICANT LIMITATIONS TO BSC'S ABILITY TO CORRELATE THE DATA TO INFORMATION PREVIOU

  Patient problems: Unspecified Infection

  MAUDE report 22587402 ↗
• InjuryJul 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS REPORT SUMMARIZES 1 SERIOUS INJURY EVENT FOR IMPLANT EMBOLIZATION. NOTE THAT MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT BUT ARE CAPTURED SEPARATELY UNDER REPORTING GUIDELINES. DEVICE RELATIONSHIP TO THE EVENTS REPORTED IS NOT PROVIDED. TYPE OF PROCEDURE: LEFT ATRIAL APPENDAGE CLOSURE. BOSTON SCIENTIFIC RECEIVED NOTIFICATION OF EVENTS FOR THE WATCHMAN LAAC DEVICE REPORTED IN THE LEFT ATRIAL APPENDAGE OCCLUSION REGISTRY (LAAO) REGISTRY, WATCHMAN SURPASS CLINICAL STUDY TO ASSESS LONG-TERM SAFETY AND EFFECTIVENESS OUTCOMES ASSOCIATED WITH THE USE AND IMPLANTATION OF THE WATCHMAN FLX LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICE WITH DELIVERY SYSTEM IN A ROUTINE CLINICAL SETTING. PATIENT EVENTS WERE REPORTED AS EVENT TERMS WITH NO FURTHER DETAILED INFORMATION. MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT, BUT ARE CAPTURED SEPARATELY UNDER THE TERMS OF THE SUMMARY REPORTING GUIDELINES. DATA INCLUDES NEWLY IMPLANTED PATIENTS AND FOLLOW UP OF PATIENTS INCLUDED IN THE PREVIOUS DATA SET. UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, DATA IS ANONYMIZED BEFORE BEING TRANSMITTED TO BSC, THUS THERE ARE SIGNIFICANT LIMITATIONS TO BSC'S ABILITY TO CORRELATE THE DATA TO INFORMATIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587401 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P130013. One submission often covers many models, so check the product and lot details in each record.

• Z-2765-2015 · Aug 25, 2015 · Terminated
  Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Delivery System, 21mm x 12F ( M635WU21060, WU21060, 24mm x 12F(M635WU24060, WU2406) , 27mm x 12F(M635WU27060,
• Z-2766-2015 · Aug 25, 2015 · Terminated
  Boston Scientific, WATCHMAN Access System Access Sheath with Dilator, 14F Single curve( M635TU10060, TU1006) , 14F Double curve (M635TU20060, TU2006) , & 14F Anterior curve (M635