WATCHMAN FLX™ M635WU50240Recalls & reported problems

Summary

The FDA's MAUDE database contains 606 adverse event reports that list this exact device (DI 08714729860495), received between Sep 24, 2020 and Sep 11, 2026 — classified as 51 deaths, 531 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (48 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 606 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  Reported via Clinical StudyIt was reported that the patient experienced a transient ischemic attack.A left atrial appendage (LAA) closure procedure was being performed. A WATCHMAN Access System (WAS) and a 24mm 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 with a complete LAA seal and deployed device diameter of 18.6 mm. There were no patient complications that were reported to have occurred. The patient was discharged on aspirin (81mg/day) and ticagrelor (180mg/day).Five (5) years post procedure, the patient presented to an outside hospital with a complaint of left-sided extremity weakness. The patient was hospitalized for further evaluation. X-ray and labs were performed in response to the event. At the time of the event, the patient was on aspirin (81 mg/day). The patient was diagnosed with experiencing a transient ischemic attack. The event is ongoing. There have been no other complications that have been reported to have occurred.

  Patient problems: Muscle Weakness/Atrophy; No Clinical Signs, Symptoms or Conditions; Transient Ischemic Attack

  MAUDE report 50735306 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Chest Pain; Thrombosis/Thrombus

  MAUDE report 50722735 ↗
• InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem

  REPORTED VIA CLINICAL STUDY. It was reported that a stroke occurred. A left atrial appendage closure (LAAC) procedure was performed. A 24mm WATCHMAN FLX LAA Closure was implanted on (b)(6) 2022. On (b)(6) 2026, the patient presented acutely confused. The physician initially considered the symptoms related to a recent extubation, medical comorbidities and likely sundowning. The symptoms continued the next day, so computed tomography (CT) imaging of the patient head was ordered. The CT showed concerns for right posterior cerebral artery (PCA) infarct. The patient was experiencing hallucinations, which worsened in the evening hours. The National Institutes of Health (NIH) stroke score was 4. The patient was not given Tenecteplase (TNK) but was on Bival. There was suspicion of embolic etiology due to Impella placement. Computed tomography angiography (CTA) of the head and neck was negative on (b)(6) 2026. By (b)(6) 2026, the patient symptoms improved and no additional stroke work up was completed.

  Patient problems: Cognitive Changes; Confusion/ Disorientation; Stroke/CVA

  MAUDE report 50244655 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  REPORTED VIA CLINICAL STUDY.It was reported thrombosis occurred.A left atrial appendage (LAA) closure procedure was performed, and a 24mm WATCHMAN FLX Closure Device was implanted on (b)(6)2022. The patient was discharged. On (b)(6)2026, the patient underwent transesophageal echocardiography (TEE) prior to a cardioversion procedure to treat recent Atrial Fibrillation. TEE imaging revealed a thrombus on the atrial surface of the Closure Device. The cardioversion procedure was cancelled, and the patient was restarted on Eliquis (BID).

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50059137 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  REPORTED VIA CLINICAL STUDY IT WAS REPORTED THAT A CEREBRAL VASCULAR ACCIDENT OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. PRIOR TO INDEX PROCEDURE, ASPIRIN WAS ADMINISTERED. ON (B)(6) 2022, THE PATIENT UNDERWENT SUCCESSFUL PLACEMENT OF A 24 MM WATCHMAN FLX LAA CLOSURE DEVICE WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 19.8MM. ON (B)(6) 2022, THE PATIENT WAS DISCHARGED ON ASPIRIN (81 MG /DAY) AND APIXABAN (10 MG /DAY). ON (B)(6) 2025, 1136 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED TO OUTSIDE FACILITY WITH THE COMPLAINTS OF SLURRED SPEECH AND FATIGUE. ON THE SAME DAY, COMPUTED TOMOGRAPHY (CT) HEAD STROKE ACTIVATION WITHOUT CONTRAST WAS PERFORMED WHICH SHOWED NO EVIDENCE OF AN ACUTE INTRACRANIAL PROCESS AND COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) OF HEAD AND NECK SHOWED NO EVIDENCE OF HIGH-GRADE STENOSIS, OCCLUSION, OR ANEURYSM. DISCOGENIC DEGENERATIVE CHANGES OF THE CERVICAL SPINE AND C6-7. A MAGNETIC RESONANCE IMAGING (MRI) OF BRAIN REVEALED ACUTE LEFT PONTINE INFARCT. THERE WAS NO EVIDENCE OF HEMORRHAGE. THERE WAS A SMALL FOCUS OF RESTRICTED DIFFUSION INVOLVING THE LEFT PONS JUST PROXIMAL TO THE PONTOMEDULLARY JUNCTION. MILD PARENCHYMA

  Patient problems: Fatigue; Speech Disorder; Stroke/CVA

  MAUDE report 24627549 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  REPORTED VIA CLINICAL STUDY. IT WAS REPORTED THAT A TRANSIENT ISCHEMIC ATTACK (TIA) OCCURRED. ON (B)(6) 2022, THE PATIENT UNDERWENT A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WITH SUCCESSFUL PLACEMENT OF A 24 MM WATCHMAN FLX CLOSURE DEVICE WITH A DEPLOYED DEVICE DIAMETER OF 18.1 MM. THE PATIENT WAS DISCHARGED THE SAME DAY ON APIXABAN (10 MG/DAY) AND ASPIRIN (81 MG/DAY). ON (B)(6) 2022, 94 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) WITH SUDDEN ONSET OF CONFUSION AND GOT DIAGNOSED WITH TRANSIENT GLOBAL AMNESIA (TGA). THE PATIENT WAS ON ASPIRIN (81 MG /DAY) AT THE TIME OF THE EVENT. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR FURTHER EVALUATION. THE NEXT DAY, MAGNETIC RESONANCE IMAGING (MRI) OF THE BRAIN WAS PERFORMED WHICH RESULTED WITHOUT ANY EVIDENCE OF ISCHEMIA. THE EVENT WAS CLASSIFIED AS TIA. ON (B)(6) 2022, THE EVENT WAS CONSIDERED TO BE RESOLVED. THE PATIENT REMAINED STABLE AND WAS DISCHARGED HOME ON ASPIRIN (81 MG/DAY).

  Patient problems: Confusion/ Disorientation; Transient Ischemic Attack

  MAUDE report 24533241 ↗
• DeathFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  REPORTED VIA CLINICAL STUDY: IT WAS REPORTED THAT CEREBRAL VASCULAR ACCIDENT AND DEATH OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED ON (B)(6) 2021 WITH SUCCESSFUL PLACEMENT OF 24MM WATCHMAN FLX CLOSURE DEVICE WITH COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 17.7MM. THE PATIENT WAS DISCHARGED SAME DAY ON ASPIRIN 81MG/DAY AND RIVAROXABAN 20MG/DAY. ON 1(B)(6) 2026, THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) FOR FOLLOW-UP AS RECOMMENDED BY PHYSICIAN AS OUTSIDE LABS REVEALED SEVERE HYPOKALEMIA WITH POTASSIUM VALUE OF 2.4 AND HIGH BODY FLUIDS. THE PATIENT REPORTED HAVING ONGOING STRUGGLES WITH LOW POTASSIUM FOR SEVERAL DAYS AND WAS ON INCREASED LEVEL OF POTASSIUM REPLACEMENT TABLETS. AT THE ER, THE PATIENT REPORTED SHORTNESS OF BREATH AND DIZZINESS, BUT DENIED CHEST PAIN, TIGHTNESS, OR PRESSURE. THE PATIENT ALSO REPORTED 3 DAYS AGO, WAKING UP FROM AN EPISODE OF CHEST PAIN WHICH EVENTUALLY RESOLVED AND DID NOT RETURN. PATIENT CONFIRMED RECENTLY HAVING A LOT OF PALPITATIONS. THE PATIENT REPORTED FATIGUE, NAUSEA, MALAISE, DIZZINESS, AND LIGHT-HEADEDNESS. PHYSICAL EXAM REVEALED MUSCULOSKELETAL WEAKNESS, PARESTHESIA OF THE TONGUE, EDEMATOUS EXTREMITIES,

  Patient problems: Chest Pain; Dysphasia; Stroke/CVA

  MAUDE report 24388571 ↗
• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

  REPORTED VIA PATIENT CALL CENTER. IT WAS REPORTED THAT A CEREBRAL VASCULAR ACCIDENT (CVA) OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 24MM WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED. ABOUT SIX (6) MONTHS POST INDEX PROCEDURE, THE PATIENT HAD A CVA. MEDICATION WAS GIVEN IN RESPONSE TO THE CVA. NO FURTHER DETAILS WERE PROVIDED. IT WAS FURTHER REPORTED THE PATIENT RECEIVED TENECTEPLASE (TNKASE) MEDICATION IN RESPONSE TO THE CVA. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED DURING THE HOSPITALIZATION, WHICH SHOWED THE CVA WAS ISCHEMIC, LOCATED IN THE LEFT CEREBRAL MIDDLE ARTERY. THE PATIENT HAD BEEN ON DUAL ANTIPLATELET THERAPY (DAPT) AFTER THE LAA CLOSURE PROCEDURE, AND NOW WAS ON ELIQUIS POST CVA. THE PATIENT WAS DISCHARGED.

  Patient problems: Stroke/CVA

  MAUDE report 24133729 ↗
• InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE WAS PERFORMED AND A 24MM WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED. APPROXIMATELY 2 YEARS LATER THE PATIENT PRESENTED FOR ATRIAL FIBRILLATION ABLATION AND UNDERWENT TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE TEE IDENTIFIED A THROMBUS ATTACHED TO THE FACE OF THE CLOSURE DEVICE. THE PATIENT WAS RESTARTED ON ANTICOAGULATION, AND THE THROMBUS IS EXPECTED TO BE REASSESSED IN 45 DAYS. THE PATIENT WAS DISCHARGED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23948648 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTED VIA CLINICAL STUDY. IT WAS REPORTED THAT PERFORATION AND DEATH OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED IN A CANINE AS PART OF A PRECLINICAL STUDY. A 24MM WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED TO BE USED. THE CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED. A GROSS NECROPSY OBSERVATIONS SHOWED PERICARDIAL ADHESIONS PRESENT ON SUPERIOR ASPECT OF THE LAA. AN ANCHOR WAS SEEN PERFORATING THE WALL ON THE LAA (ADHESIONS NOT ASSOCIATED WITH PERFORATION). NO MAJOR CONCERNING FINDINGS RELATED TO CARDIAC FUNCTION OR OVERALL ANIMAL HEALTH WERE REPORTED DURING THE IN-LIFE PERIOD OF THE STUDY FOR THIS ANIMAL. PATHOLOGY CONFIRMED AN ANCHOR WAS SEEN PERFORATING THE WALL ON THE LAA.

  Patient problems: Cardiac Perforation

  MAUDE report 23523765 ↗
• InjuryOct 28, 2025Failure to Seal; Failure to Seal

  IT WAS REPORTED A CEREBRAL VASCULAR ACCIDENT, AND A DEVICE LEAK OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 24MM WATCHMAN FLX LAA CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED ON (B)(6) 2024. THE PATIENT WAS DISCHARGED. ON (B)(6) 2025, A REVIEW FOLLOWING TRANSESOPHAGEAL ECHOCARDIOGRAPHY WAS COMPLETED, AND A CLOSURE DEVICE LEAK WAS NOTED ON THE MITRAL SIDE. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED A STROKE, THE SYMPTOMS ARE UNKNOWN. THE PATIENT DID NOT REQUIRE ANY IMMEDIATE INTERVENTIONS TO MANAGE THE STROKE. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT.

  Patient problems: Stroke/CVA

  MAUDE report 23403088 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTED VIA CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CEREBRAL VASCULAR ACCIDENT. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) AND A 24MM WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED TO BE USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE CLOSURE DEVICE IMPLANTED WITH A LAA COMPLETE SEAL AND DEPLOYED DEVICE DIAMETER OF 19.0 MM. THERE WERE NO PATIENT COMPLICATIONS THAT WERE REPORTED TO HAVE OCCURRED. THE PATIENT WAS DISCHARGED ON ASPIRIN (81 MG /DAY) AND APIXABAN (10 MG/DAY). TWO YEARS POST PROCEDURE THE PATIENT HAD AN OFFICE VISIT FOR COGNITIVE AND BEHAVIORAL CHANGES WHICH WAS ASSOCIATED WITH SYMPTOMS OF ATAXIA AND TREMOR. THE PATIENTS FAMILY WAS NOTICING CHANGES IN BEHAVIOR, LIKE BEING QUIETER LESS TALKATIVE AND HAD A CHANGE IN FACIAL EXPRESSIONS AND INCREASED FORGETFULNESS. UPON REVIEW OF SYSTEM, THE PATIENT SHOWED MUSCULOSKELETAL GAIT ABNORMALITY (SHUFFLING) AND HAND TREMORS. PHYSICAL EXAMINATION REVEALED GAIT SHUFFLING AND NO OTHER SIGNIFICANT FINDINGS NOTED. THE PATIENT WAS FURTHER REFERRED TO NEUROLOGY, FOR EVALUATION AND MANAGEMENT. TEN DAYS LATER MAGNETIC RESONANCE IM

  Patient problems: Balance Problems; Cognitive Changes; Dysphasia; Movement Disorder; Shaking/Tremors; Stroke/CVA

  MAUDE report 23367932 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTED VIA CLINICAL REPORT: IT WAS REPORTED THAT THE PATIENT EXPERIENCED A TRANSIENT ISCHEMIC ATTACK. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. ON (B)(6) 2023, THE PATIENT UNDERWENT SUCCESSFUL PLACEMENT OF A 24MM WATCHMAN FLX CLOSURE DEVICE WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 19.8 MM. ON THE SAME DAY, THE PATIENT WAS DISCHARGED ON ASPIRIN (81MG/DAY) AND RIVAROXABAN (20 MG/DAY). ON (B)(6) 2025, 798 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED TO EMERGENCY DEPARTMENT (ED) WITH COMPLAINTS OF SPEAKING WORDS THAT DID NOT MAKE SENSE WHICH LASTED FOR 10 MINUTES. ON THE SAME DAY, A COMPUTED TOMOGRAPHY (CT) WAS PERFORMED WHICH REVEALED NO ACUTE CHANGES. AT THE TIME OF THE EVENT, THE PATIENT WAS ON ASPIRIN 81 MG /DAY. NO ACTION WAS TAKEN IN RESPONSE TO THE EVENT. ON (B)(6) 2025, THE OUTCOME OF THE EVENT WAS CONSIDERED TO BE RESOLVED, AND THE PATIENT WAS DISCHARGED FROM THE EMERGENCY ROOM (ER). ON (B)(6) 2025, MODIFIED RANKIN SCALE (MRS) WAS PERFORMED, AND SCORE WAS NOTED TO BE 0. ON (B)(6) 2025, MODIFIED RANKIN SCALE (MRS) 90 DAYS WAS PERFORMED, AND SCORE WAS NOTED TO BE 0.

  Patient problems: Speech Disorder; Transient Ischemic Attack

  MAUDE report 23359252 ↗
• InjuryOct 20, 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 (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 24MM WATCHMAN FLX CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED ON (B)(6) 2023. THE PATIENT WAS DISCHARGED. THE PATIENT WAS ADMITTED FOR RIGHT FEMORAL ARTERY THROMBUS AND DURING FURTHER TESTING, BY ECHOCARDIOGRAM A DEVICE RELATED THROMBUS (DRT) WAS NOTED ON THE CLOSURE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23335453 ↗
• DeathOct 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING EVENT ORIGINATED FROM A PATIENT CALLING THE WATCHMAN PATIENT CALL CENTER, AND THEREFORE DESPITE GOOD FAITH EFFORTS THE INFORMATION IS OFTEN INCOMPLETE. ADDITIONALLY, DUE TO THE LIMITED INFORMATION RECEIVED THROUGH GOOD FAITH EFFORTS, THIS EVENT MAY REPRESENT A DUPLICATE OF AN EVENT WHICH WAS ALREADY KNOWN TO BOSTON SCIENTIFIC. IT WAS REPORTED A CEREBRAL VASCULAR ACCIDENT (CVA) AND DEATH OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED ON (B)(6) 2023, AND A 24MM WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED. THE PATIENT PASSED AWAY ON (B)(6) 2025, FOLLOWING THREE STROKES IN A ROW. THE FIRST STROKE WAS AT THE END OF (B)(6) 2025, THE SECOND STROKE WAS THREE WEEKS LATER LEAVING THE PATIENT PARALYZED, AND THE THIRD AND FINAL STROKE OCCURRED 1.5 MONTHS LATER AND WAS DESCRIBED AS A "MASSIVE STROKE". THE PATIENT WAS DISCHARGED HOME AFTER AND THEN DIED WHICH WAS TWO DAYS FOLLOWING THE FINAL STROKE. THERE WERE NO FURTHER DETAILS REPORTED.

  Patient problems: Paralysis; Stroke/CVA

  MAUDE report 23234215 ↗
• InjuryAug 28, 2025Failure to Seal; Failure to Seal

  REPORTED VIA PATIENT CALL CENTER. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A TRANSIENT ISCHEMIC ATTACK. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 24MM WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED ON (B)(6) 2022. THE PATIENT WAS DISCHARGED. THE PATIENT STATED THAT APPROXIMATELY 18 MONTHS AGO THEY SUFFERED A TRANSIENT ISCHEMIC ATTACK (TIA). THE PATIENT ALSO STATED THAT THEY HAD A TRANSESOPHAGEAL ECHOCARDIOGRAPHY THAT SHOWED A 3.9MM LEAK AND THE PHYSICIAN SCHEDULED A SURGERY TO CORRECT THE LEAK. THE PATIENT STATED THAT THEY WERE PLACED UNDER GENERAL ANESTHESIA AND WHEN THEY WOKE UP FROM THE PROCEDURE, THE PHYSICIAN STATED THAT THE LEAK WAS NOT BIG ENOUGH TO DO ANYTHING ABOUT IT. THE PATIENT WAS PLACED BACK ON 5MG ELIQUIS TWICE A DAY AND IS LOOKING FOR ANY RECOURSE AND NEXT STEPS TO COME OFF THE BLOOD THINNER MEDICATION. THE PATIENT NOTED THAT AFTER IMPLANT FOLLOW UP VISIT, THE PHYSICIAN TOLD THEM THAT THEY HAD A SMALL LEAK AND THAT HEART TISSUE WILL GROW AROUND THE CLOSURE DEVICE AND CLOSE, BUT THE HEART TISSUE HAS NOT GROWN OVER THE CLOSURE DEVICE AT THIS TIME.

  Patient problems: Transient Ischemic Attack

  MAUDE report 22914473 ↗
• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING EVENT ORIGINATED FROM A PATIENT CALLING THE WATCHMAN PATIENT CALL CENTER, AND THEREFORE DESPITE GOOD FAITH EFFORTS THE INFORMATION IS OFTEN INCOMPLETE. ADDITIONALLY, DUE TO THE LIMITED INFORMATION RECEIVED THROUGH GOOD FAITH EFFORTS, THIS EVENT MAY REPRESENT A DUPLICATE OF AN EVENT WHICH WAS ALREADY KNOWN TO BOSTON SCIENTIFIC. IT WAS REPORTED THAT THROMBOSIS OCCURRED. THE PATIENT WAS TAKING A BLOOD THINNER PRIOR TO THE INDEX PROCEDURE. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 24MM WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED. THE PATIENT WAS TAKING PLAVIX AND ASPIRIN POST INDEX PROCEDURE, AND THEN ULTIMATELY JUST ASPIRIN. APPROXIMATELY OVER (1) YEAR POST INDEX PROCEDURE, THE PATIENT EXPERIENCED SHORTNESS OF BREATH AND WAS HOSPITALIZED, AND DEVICE RELATED THROMBUS (DRT) ON THE CLOSURE DEVICE, THROMBOSIS IN BILATERAL LOWER EXTREMITIES, AND THROMBOSIS IN THE LUNGS WERE FOUND. NO FURTHER DETAILS WERE PROVIDED AT THE TIME OF THIS REPORT.

  Patient problems: Dyspnea; Pulmonary Embolism; Thromboembolism; Thrombosis/Thrombus

  MAUDE report 22883652 ↗
• InjuryAug 4, 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 (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 24MM WATCHMAN FLX DELIVERY SYSTEM (WDS) WAS SUCCESSFULLY IMPLANTED ON (B)(6) 2023. THE PATIENT WAS DISCHARGED. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED TO EVALUATE THE LEFT ATRIAL APPENDAGE PRIOR TO THE ABLATION AND A CLOT WAS NOTED ATTACHED TO THE OUTER EDGE OF THE CLOSURE DEVICE. THE CASE WAS CANCELLED DUE TO RISK OF DISLODGING THE CLOT. THERE WERE NO PATIENT COMPLICATIONS. THEY PLAN TO BRING THE PATIENT BACK AT A LATER DATE AND HOPE THE CLOT HAS CLEARED. THERE WAS NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22699796 ↗
• DeathJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT SUMMARIZES 4 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: 52 TO 81 YEARS. PATIENT SEX: 1 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 22580502 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT SUMMARIZES 4 SERIOUS INJURY EVENTS 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. AGE RANGE: 65 TO 86 YEARS. PATIENT SEX: 1 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 LIMITATION

  Patient problems: Thromboembolism

  MAUDE report 22580497 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT SUMMARIZES 8 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: 71 TO 80 YEARS. PATIENT SEX: 7 FEMALES; 1 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 22580488 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT SUMMARIZES 3 SERIOUS INJURY EVENTS FOR ENDOCARDITIS. 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: 52 TO 88 YEARS. PATIENT SEX: 2 FEMALES; 1 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 FLX DAPT 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

  Patient problems: Endocarditis

  MAUDE report 22580334 ↗
• DeathJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT SUMMARIZES 1 DEATH EVENT FOR SUDDEN CARDIAC DEATH. 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 PREVIOUS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22580261 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT SUMMARIZES 11 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 11 SERIOUS INJURY THROMBOSIS EVENTS: 4 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: 53 TO 88 YEARS. PATIENT SEX: 5 FEMALES; 6 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

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22580256 ↗
• InjuryJul 23, 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 FLX DAPT 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 INFORMATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22580235 ↗

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-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
• 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,