WATCHMAN FLX™ M635WU50350Recalls & reported problems

Summary

The FDA's MAUDE database contains 231 adverse event reports that list this exact device (DI 08714729860525), received between Oct 1, 2020 and Mar 3, 2026 — classified as 12 deaths, 201 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (43 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 231 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Nonstandard Device; Migration

  IT WAS REPORTED THAT A DEVICE SHIFT OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 35MM WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED ON (B)(6) 2024. THE PATIENT WAS DISCHARGED. AT THE ROUTINE 45-DAY FOLLOW-UP, COMPUTED TOMOGRAPHY IMAGING REVEALED THE DEVICE HAD SHIFTED. NO INTERVENTION WAS PERFORMED AND THERE WERE NO PATIENT COMPLICATIONS. UPON ANALYSIS, IT WAS FOUND THAT THE CT IMAGING SHOWED CROSSED TINES AND THE DEVICE PUCK IN THE CENTER OF THE DEVICE, INDICATING A DEVICE FRACTURE DUE TO AXIAL COMPRESSION OF THE DEVICE IN ITS CURRENT POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24499694 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  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 35MM 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. THREE (3) YEARS POST PROCEDURE IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CEREBRAL VASCULAR ACCIDENT. NO TREATMENT OR INTERVENTIONS WERE REPORTED TO HAVE OCCURRED. NO OTHER COMPLICATIONS WERE REPORTED TO HAVE OCCURRED AS A RESULT OF THIS EVENT.

  Patient problems: Stroke/CVA

  MAUDE report 24475555 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  REPORTED VIA PATIENT CALL CENTER. IT WAS REPORTED THAT TRANSIENT ISCHEMIC ATTACK (TIA) OCCURRED. A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE WAS PERFORMED, AND A 35MM WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED IN 2021. THE PATIENT EXPERIENCED A RECENT TIA.

  Patient problems: Transient Ischemic Attack

  MAUDE report 24390121 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CEREBRAL VASCULAR ACCIDENT OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. ON (B)(6) 2022, THE PATIENT UNDERWENT SUCCESSFUL PLACEMENT OF A 35 MM WATCHMAN FLX DEVICE WITH COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 27 MM. THE PATIENT WAS DISCHARGED ON ASPIRIN (81 MG/DAY) AND APIXABAN (10 MG /DAY). ON (B)(6) 2026, 1288 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) WITH THE COMPLAINT OF LEFT SIDED WEAKNESS AND SENSORY LOSS OF LEFT FACE. IN THE ER, THE PATIENT WAS STARTED WITH TENECTEPLASE (TNK) AND ADMITTED TO THE INTENSIVE CARE UNIT (ICU). A COMPUTED TOMOGRAPHY (CT) HEAD WAS PERFORMED WHICH REVEALED INFARCT WITHIN THE PARIETAL OCCIPITAL LOBE. THE SITE REPORTED THE EVENT OF ACUTE ISCHEMIC STROKE. AT THE TIME OF THE EVENT THE PATIENT WAS ON ASPIRIN (81 MG /DAY). THE PATIENT WAS HOSPITALIZED. NON-SURGICAL INTERVENTION WAS PERFORMED; ORAL, INTRAVENOUS AND INTRAMUSCULAR (IV/IM) MEDICATIONS WERE PROVIDED. ON (B)(6) 2026, NIH STROKE SCALE (NIHSS) SCORE WAS NOTED TO BE 2. ON (B)(6) 2026, MODIFIED RANKIN SCALE (MRS) SCORE WAS NOTED TO BE 3 (MODERATE). ON (B)(6) 2026, THE OUTCOME OF THE EVENT WAS CONSIDERED TO

  Patient problems: Dizziness; Facial Paralysis; High Blood Pressure/ Hypertension; Loss of Vision; Muscle Weakness/Atrophy; Numbness; Paralysis; Stroke/CVA

  MAUDE report 24345025 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  REPORTED VIA LITERATURE ARTICLE. 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 35MM 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 APIXABAN, BUT IT WAS DISCONTINUED DUE TO RECURRENT NOSEBLEEDS, AND THEY CONTINUED ON LOW-DOSE ASPIRIN. THE PATIENT CAME IN TWO (2) YEARS POST PROCEDURE, AND AN IMAGING PROCEDURE WAS PERFORMED. THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING SHOWED THAT THERE WAS A DEVICE RELATED THROMBUS PRESENT ON THE CLOSURE DEVICE. COMPUTED TOMOGRAPHIC IMAGING DEMONSTRATED A LARGE MOBILE HYPOATTENUATED CYLINDRICAL SHAPED MASS VISUALIZED IN THE LEFT ATRIUM WITH ATTACHMENT TO THE CLOSURE DEVICE IN THE LEFT ATRIAL APPENDAGE. THE DISTAL PORTION OF THE MASS ABUTS THE ATRIAL ASPECT OF THE ANTERIOR LEAFLET OF THE MITRAL VALVE. THE CLOSURE DEVICE WAS WELL SEATED WITH NO EVIDENCE OF PERIDEVICE LEAK. AFTER MULTIDISCIPLINARY

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24315286 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED A PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 35MM WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED. THE PROCEDURE WAS UNEVENTFUL, AND THE PATIENT WAS DISCHARGED HOME ON APIXABAN AND ASPIRIN. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) PERFORMED DURING THE PROCEDURE CONFIRMED SUCCESSFUL DEVICE PLACEMENT WITHOUT ANY PERICARDIAL EFFUSION (PE). A REPEAT TEE 45 DAYS LATER SHOWED STABLE PLACEMENT OF THE WATCHMAN FLX CLOSURE DEVICE WITH NO THROMBUS, LEAKS, OR PE. ACCORDINGLY, THE DECISION WAS MADE TO STOP APIXABAN AND TO START CLOPIDOGREL FOR A TOTAL OF 6 MONTHS POST PROCEDURE. FIVE MONTHS AFTER IMPLANTATION, THE PATIENT PRESENTED WITH CHEST PAIN AND SHORTNESS OF BREATH. A TRANSTHORACIC ECHOCARDIOGRAM REVEALED A SMALL TO MODERATE PE WITHOUT SIGNS OF TAMPONADE. THE WATCHMAN FLX CLOSURE DEVICE REMAINED STABLE WITH NO COMPLICATIONS, AND THE PATIENT WAS DIAGNOSED WITH PERICARDITIS AND TREATED AS PER GUIDELINES BEFORE BEING DISCHARGED. SIX MONTHS POST IMPLANTATION, REPEAT TRANSESOPHAGEAL ECHOCARDIOGRAM REVEALED A THROMBUS ON THE EPICARDIAL ASPECT OF LAA AND A LARGE POSTERIOR PERICARDIAL EFFUSION. THE PAT

  Patient problems: Cardiac Perforation; Chest Pain; Dyspnea; Pericardial Effusion; Pericarditis; Thrombosis/Thrombus

  MAUDE report 23973784 ↗
• InjuryDec 23, 2025Failure to Seal; Failure to Seal

  REPORTED VIA PATIENT CALL CENTER. IT WAS REPORTED THAT A DEVICE LEAK OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 35MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED ON (B)(6) 2021. THE PATIENT WAS DISCHARGED. THE PATIENT STATED THAT DURING THE LAST ROUTINE FOLLOW UP TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE), THE CLOSURE DEVICE SHOWED A LEAK. THE PATIENT REMAINS ON ELIQUIS MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23877644 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A CEREBRAL VASCULAR ACCIDENT (CVA) AND THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 35MM WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE SEAL NOTED. THE PATIENT WAS SENT HOME ON ELIQUIS. THE 45-DAY ROUTINE ECHOCARDIOGRAM WAS WITHIN NORMAL LIMITS. 1,234 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED WITH A THROMBOEMBOLIC CVA. UPON DOING A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE), IT REVEALED THERE WAS A DEVICE RELATED THROMBUS (DRT) LOCATED ON THE FACE OF THE CLOSURE DEVICE. THE CLOSURE DEVICE WAS SEEN WELL POSITIONED WITHIN THE LAA 3 YEARS POST IMPLANT. THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 23609638 ↗
• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTED VIA LITERATURE ARTICLE. IT WAS REPORTED THAT THROMBOSIS AND CEREBRAL VASCULAR ACCIDENT OCCURRED. AN 80-YEAR-OLD MALE PATIENT UNDERWENT PERCUTANEOUS LEFT ATRIAL APPENDAGE CLOSURE (LAAC) USING A 35MM WATCHMAN FLX CLOSURE DEVICE DUE TO PRIOR EMBOLIC EVENTS DESPITE ORAL ANTICOAGULATION (OAC) AND ELEVATED BLEEDING RISK, RESULTING IN THE EFFECTIVE SEALING OF THE LEFT ATRIAL APPENDAGE. THE PATIENT WAS DISCHARGED WITHOUT COMPLICATIONS ON POSTOPERATIVE DAY TWO (2). A FOLLOW-UP TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS PERFORMED ON DAY 44 AND CONFIRMED CLOSURE DEVICE STABILITY WITHOUT LEAK OR THROMBUS. ACCORDING TO LOCAL PROTOCOL, APIXABAN WAS DISCONTINUED, AND DUAL ANTIPLATELET THERAPY (ASPIRIN AND PRASUGREL) WAS INITIATED. ON POSTOPERATIVE DAY 236, FOLLOW-UP CORONARY ANGIOGRAPHY REVEALED NO RESTENOSIS, LEADING TO THE DECISION TO CONTINUE ONLY PRASUGREL 3.75 MG DAILY, WITH THE DISCONTINUATION OF ASPIRIN. ON POSTOPERATIVE DAY 314, THE PATIENT WAS HOSPITALIZED WITH LEFT HOMONYMOUS HEMIANOPIA. BRAIN MAGNETIC RESONANCE IMAGING (MRI) CONFIRMED AN ISCHEMIC STROKE, AND TEE REVEALED A HIGH-GRADE PEDUNCULATED GRADE 3 DEVICE-RELATED THROMBUS (DRT) MEASURING 17 X 20 MM ATTACHED TO THE SURFAC

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 23379575 ↗
• DeathOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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. ON (B)(6) 2022, UNDERWENT SUCCESSFUL PLACEMENT OF 35 MM WATCHMAN FLX DEVICE WITH COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 30.0 MM. ON (B)(6) 2022 THE PATIENT WAS DISCHARGED ON ASPIRIN (81 MG/DAY) AND APIXABAN (5 MG/DAY). ON (B)(6) 2025, 1269 DAYS POST INDEX PROCEDURE, THE PATIENT PASSED AWAY. OF NOTE THE CAUSE OF DEATH IS UNKNOWN AND NO OTHER INFORMATION OR RECORDS ARE AVAILABLE. AT THE TIME OF DEATH, THE PATIENT WAS ON ASPIRIN (81 MG/DAY). NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Heart Failure/Congestive Heart Failure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23316799 ↗
• InjurySep 29, 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 BEING PERFORMED AND A 35MM WATCHMAN FLX PRO LAA CLOSURE DEVICE WAS IMPLANTED ON (B)(6) 2022, AND THE PATIENT WAS DISCHARGED WITHOUT INCIDENT. ON (B)(6) 2025, THE WATCHMAN COORDINATOR INFORMED OF A NON-MOBILE THROMBUS LOCATED IN THE LEFT ATRIUM ON TOP OF THE CLOSURE DEVICE. THE THROMBUS WAS DISCOVERED VIA COMPUTED TOMOGRAPHY (CT) SCAN FOR AN UNRELATED PROCEDURE. THE PATIENT WAS PLACED BACK ON ANTICOAGULATION MEDICATION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23168111 ↗
• InjurySep 4, 2025Failure to Seal; Failure to Seal

  REPORTED VIA PATIENT CALL CENTER. IT WAS REPORTED THAT DEVICE DID NOT SEAL, STROKE, THROMBOSIS, AND HEMATOMA OCCURRED. A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE WAS PERFORMED AND A 35MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED ON (B)(6) 2023. POST-PROCEDURE THE PATIENT WAS TAKING BLOOD THINNING MEDICATION. AT THE 45-DAY FOLLOW-UP, IMAGING SHOWED THAT THE 35MM WATCHMAN FLX CLOSURE DEVICE DID NOT HAVE A COMPLETE SEAL. THE PATIENT WAS INSTRUCTED TO TAKE ASPIRIN 81MG. IN OCTOBER (YEAR NOT SPECIFIED) THE PATIENT EXPERIENCED A STROKE. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED WHICH IDENTIFIED THROMBUS ON THE 35MM WATCHMAN FLX CLOSURE DEVICE. THE PATIENT WAS STARTED ON INTRAVENOUS HEPARIN FOR 5 DAYS WHICH PARTIALLY RESOLVED THE THROMBUS. THE PATIENT WAS PLACED ON ELIQUIS. AT AN UNSPECIFIED TIME, ANOTHER TEE WAS PERFORMED WHICH SHOWED PERSISTENCE OF SMALL THROMBUS. ANOTHER TEE WAS LATER PERFORMED WHICH SHOWED THE THROMBUS HAD RESOLVED. ON (B)(6) (YEAR UNSPECIFIED) THE PATIENT VISITED THE HOSPITAL DUE TO CHEST PAIN. THE PATIENT'S TROPONIN WAS ELEVATED, AND ANOTHER THROMBUS WAS IDENTIFIED ON THE 35MM WATCHMAN FLX CLOSURE DEVICE. THE PATIENT WAS STARTED ON LOVENOX. THE PATIENT D

  Patient problems: Cardiac Enzyme Elevation; Chest Pain; Hematoma; Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 22965518 ↗
• InjuryAug 19, 2025Failure to Seal; Failure to Seal

  REPORTED VIA PATIENT CALL CENTER. IT WAS REPORTED THAT A DEVICE LEAK OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 35MM WATCHMAN FLX PRO CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED ON (B)(6) 2023. THE PATIENT WAS DISCHARGED. THE PATIENT STATED THAT HAS A LEAK AND THAT THE PHYSICIANS ATTEMPTED TO FIX THE LEAK. THE PATIENT STATED THAT WAS TOLD THE TISSUE DID NOT GROW OVER THE LEAK, IT WAS A SLIGHT LEAK, AND THAT THE REPAIR FAILED. THE PATIENT STILL ON ELIQUIS, AND STATED THE PHYSICIANS MENTIONED ANOTHER POSSIBLE REPAIR THE PATIENT ALSO STATED THAT WOULD LIKE TO GET OFF HIS BLOOD THINNER.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 22841864 ↗
• InjuryJul 24, 2025Failure to Seal; Failure to Seal

  REPORTED VIA LITERATURE ARTICLE. IT WAS REPORTED THE DEVICE DID NOT SEAL. PREPROCEDURAL TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) SHOWED A MARKEDLY ENLARGED LEFT ATRIUM (LA), PRESERVED LEFT VENTRICULAR EJECTION FRACTION (69%), AND MILD MITRAL REGURGITATION. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) SHOWED NO THROMBUS IN THE LEFT ATRIAL APPENDAGE (LAA) OR THE LA. THE PATIENT UNDERWENT PERCUTANEOUS LEFT ATRIAL APPENDAGE CLOSURE (LAAC) THROUGH THE IMPLANTATION OF A 35MM WATCHMAN FLX CLOSURE DEVICE. IMMEDIATE POSTPROCEDURAL TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IMAGING SHOWED A WELL-SEATED WATCHMAN DEVICE WITH NO RESIDUAL LEAK. A FOLLOW-UP TEE PERFORMED 10 WEEKS AFTER DEVICE IMPLANTATION WAS UNREMARKABLE, WITH NO RESIDUAL LEAK OR THROMBUS, AND ANTICOAGULATION THERAPY WAS STOPPED. SUBSEQUENT TEE WAS PERFORMED 17 MONTHS AFTER DEVICE IMPLANTATION, DUE TO ABNORMAL GAP AROUND THE DEVICE NOTED ON CARDIAC COMPUTED TOMOGRAPHY DONE FOR CHEST PAIN. TEE FINDINGS WERE SUSPICIOUS FOR A RESIDUAL LEAK BY COLOR DOPPLER, BUT A DEFINITE DIAGNOSIS COULD NOT BE MADE. AN ECHO CONTRAST AGENT WAS THEN USED, WHICH CLEARLY SHOWED A RESIDUAL LEAK AROUND THE DEVICE LOCATED AT THE LATERAL ASPECT OF THE APPENDAGE (AT 0 D

  Patient problems: Chest Pain

  MAUDE report 22593998 ↗
• 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 22587669 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT SUMMARIZES 4 SERIOUS INJURY EVENTS FOR HOSPITALIZATION OR PROLONGED HOSPITALIZATION. 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: 67 TO 87 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 THER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587513 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT SUMMARIZES 4 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: 65 TO 84 YEARS. PATIENT SEX: 2 FEMALE; 2 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 22587483 ↗
• InjuryJul 24, 2025Difficult to Open or Close; Difficult to Open or Close

  THIS REPORT SUMMARIZES 1 SERIOUS INJURY EVENT FOR DEVICE LEAK. 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 PREVIOUSL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587481 ↗
• DeathJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT SUMMARIZES 5 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: 75 TO 85 YEARS, PATIENT SEX: 2 FEMALES; 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 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

  Patient problems: Stroke/CVA

  MAUDE report 22580492 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT SUMMARIZES 2 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. 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 INFORMATION P

  Patient problems: Thromboembolism

  MAUDE report 22580224 ↗
• 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 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 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 INFORMATION PREVIOUSLY

  Patient problems: Thromboembolism

  MAUDE report 22580190 ↗
• 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 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. 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22579672 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT SUMMARIZES 5 SERIOUS INJURY EVENTS FOR HOSPITALIZATION OR PROLONGED HOSPITALIZATION. 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: 66 TO 84 YEARS. PATIENT SEX: 2 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 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 TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22578292 ↗
• 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 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. AGE RANGE: 67 TO 84. PATIENT SEX: 1 FEMALE; 2 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22578243 ↗
• 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 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: 71 TO 84 YEARS. PATIENT SEX: 2 FEMALE; 2 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 SIGNI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22578233 ↗

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