WATCHMAN FLX™ M635WU50270Recalls & reported problems

Summary

The FDA's MAUDE database contains 731 adverse event reports that list this exact device (DI 08714729860501), received between Oct 2, 2020 and Sep 29, 2026 — classified as 43 deaths, 663 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Migration” (90 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 731 reports, in the reporter's own words as published by the FDA.

• 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 21, 2026Migration

  It was reported that thrombosis and device migration occurred.The patient previously underwent a left atrial appendage (LAA) closure procedure in 2023, and a 27mm WATCHMAN FLX Closure Device was implanted.Approximately two years post implant, the patient was scheduled to undergo an ablation procedure. Prior to the procedure, thrombus was identified within the LAA and the ablation was cancelled. The patient was also informed that the Closure Device had shifted distally within the appendage.The patient was subsequently treated with anticoagulation and was advised that long-term blood thinner therapy would be required. At the time of reporting, the thrombus had resolved.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50843400 ↗
• InjurySep 4, 2026Nonstandard Device; Failure to Seal

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600711 ↗
• DeathAug 6, 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. The patient was on apixaban (10 mg/day) therapy prior to enrollment into the study. On (b)(6) 2023 implant transesophageal echocardiography (TEE) assessment revealed 2 LAA lobes with an ostium diameter of 23.3 mm and length of 39.1mm. On (b)(6) 2023, the patient got crossover and successful placement of 27mm WATCHMAN FLX device with complete LAA seal and deployed device diameter of 22.7mm. Prior to the implant procedure aspirin was administered. The patient was discharged on the same day on apixaban (10 mg/day) and aspirin (81 mg/day). On (b)(6) 2026,1039 days post index procedure, the patient passed away and the cause of death is unknown. At the time of death, the patient was not on any anticoagulant/ antiplatelet medication. No action taken and diagnostics was performed in response to the event. No further information available at this time.It was further reported that the sponsor device causality assessment is not related, the complaint will be close as not a complaint.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50165898 ↗
• InjuryJul 29, 2026Migration

  It was reported device migration occurred. A left atrial appendage (LAA) closure procedure was performed, and a 27mm WATCHMAN FLX Closure Device was implanted on (b)(6)-2023. The patient was discharged. At a routine follow up, it was found that the Closure Device had shifted very proximal in the appendage and was only attached by a few of the bottom row anchors. The physician removed the Closure Device using a percutaneous snare and implanted a new 27mm WATCHMAN FLX Pro Closure Device without complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50074526 ↗
• DeathJun 15, 2026Adverse Event Without Identified Device or Use Problem

  Reported via Clinical Study. It was reported that the patient experienced a cerebral vascular accident and the patient died. A left atrial appendage (LAA) closure procedure was being performed. A WATCHMAN Access System (WAS) and a 27mm 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. Four (4) years post procedure the patient presented to the emergency room with new onset aphasia and rightward gaze deviation. Computed Tomography (CT) of the brain/neck showed no acute intracranial abnormality, no large vessel occlusion, or high-grade stenosis. Magnetic Resonance imaging (MRI) showed an acute nonhemorrhagic L paramedian pontine infarct on the brain. There was no deep vein thrombosis, no leak or thrombosis on CT of the heart. The patient developed dysphagia. The patient's family decided on home hospice and the patient was discharged home five (5) days after presenting to the hospital. Eleven (11) days after the onset of this event the patient died.

  Patient problems: Dysphagia/ Odynophagia; Dysphasia; Stroke/CVA

  MAUDE report 25505780 ↗
• InjuryMay 20, 2026Failure to Seal

  REPORTED VIA PATIENT CALL CENTER. IT WAS REPORTED A DEVICE LEAK OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 27 MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED ON (B)(6) 2024. THE PATIENT WAS SUBSEQUENTLY DISCHARGED. IN (B)(6) 2024, THE PATIENT CONTACTED THE WATCHMAN CALL CENTER AND REPORTED THAT A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED A 13MM PERI-DEVICE LEAK. HOWEVER, CARDIOLOGY REVIEWED THE IMAGING AND DETERMINED THE LEAK MEASURED LESS THAN 4MM. THE PATIENT ALSO REPORTED EXPERIENCING VISUAL AURAS BEGINNING POSTOPERATIVELY IN 2024. IN (B)(6) 2025, THE PATIENT UNDERWENT CLOSURE OF AN ATRIAL SEPTAL DEFECT/PATENT FORAMEN OVALE (ASD/PFO), BUT THE VISUAL AURAS PERSISTED. AT A FOLLOW-UP VISIT IN LATE (B)(6) 2026, A CTA DEMONSTRATED A 6MM X 15MM SUPERIOR PERI-DEVICE LEAK, WHICH RADIOLOGY NOTED WAS UNCHANGED FROM THE 2024 IMAGING. THE PATIENT REPORTED THAT CARDIOLOGY ADVISED THAT THE LEAK NOW REQUIRES INTERVENTION.

  Patient problems: Visual Disturbances

  MAUDE report 25232059 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS AN INFECTION. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) AND A 27MM 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. TWO YEARS POST PROCEDURE IT WAS REPORTED THAT THE PATIENT HAD BEEN DIAGNOSED WITH MRSA FOUND ON THE CLOSURE DEVICE.

  Patient problems: Bacterial Infection

  MAUDE report 24570317 ↗
• InjuryFeb 20, 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 27MM 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 THE PATIENT WAS HAVING AN OPEN-HEART SURGERY. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING PROCEDURE WAS PERFORMED. THE IMAGING SHOWED A MASS/THROMBUS ON THE FACE OF THE CLOSURE DEVICE. THE CLOSURE DEVICE IS WELL POSITIONED WITH NO LEAKS OR GAPS. THE PHYSICIAN REMOVED THE MASS WITHOUT COMPLICATIONS. THERE WERE NO OTHER COMPLICATIONS THAT WERE REPORTED TO HAVE OCCURRED. THE PATIENT REMAINS HOSPITALIZED DUE TO NORMAL RECOVERY PERIOD POST OPEN-HEART SURGERY.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24405090 ↗
• InjuryFeb 19, 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 27MM WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED ON (B)(6) 2024. THE PATIENT WAS DISCHARGED ON WARFARIN FOR 6 WEEKS AND THEN TRANSITIONED TO DUAL ANTIPLATELET THERAPY (DAPT). ON (B)(6) 2024, DURING A TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE), A SMALL THROMBUS WAS NOTED. THE PATIENT WAS PLACED ON XARELTO FOR THREE (3) MONTHS. ON (B)(6) 2024, TEE IMAGING SHOWED RESOLUTION OF THE THROMBUS. THE PATIENT WAS PLACED ON 81MG OF ASPIRIN. DURING THE ROUTINE ONE YEAR FOLLOW UP TEE ON (B)(6) 2025, IMAGING SHOWED A THROMBUS ON THE INSERTION OF THE LAAO. THE PATIENT CONTINUED ON 81MG ASPIRIN. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED ON (B)(6) 2026, AND IMAGING SHOWED NO THROMBUS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24389220 ↗
• InjuryFeb 18, 2026Migration; Failure to Seal

  IT WAS REPORTED THAT A DEVICE LEAK AND IMPLANT MOVEMENT/SHIFT OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 27MM WATCHMAN FLX CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED ON (B)(6) 2024. THE PATIENT WAS DISCHARGED. DURING A ROUTINE 45-DAY FOLLOW-UP ON (B)(6) 2024, IT WAS NOTED THERE WAS A LEAK DUE TO CLOSURE DEVICE SHIFTING. NO INFORMATION WAS PROVIDED AT THAT TIME. THE LEAK WAS BELOW THE FABRIC AND HAD NOT ENDOTHELIALIZED. A COMPUTED TOMOGRAPHY (CT) WAS PERFORMED AFTER MULTIPLE TRANSESOPHAGEAL ECHOCARDIOGRAPHY'S. THE PATIENT REMAINS ON WARFARIN. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377820 ↗
• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBOSIS AND TRANSIENT ISCHEMIC ATTACK OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 27MM WATCHMAN FLX DELIVERY SYSTEM WAS SUCCESSFULLY IMPLANTED ON (B)(6) 2023. THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY (DAPT) FOR SIX (6) MONTHS AND THEN SWITCHED TO ASPIRIN. ON (B)(6) 2025 THE PATIENT PRESENTED TO THE HOSPITAL WITH TRANSIENT ISCHEMIC ATTACK (TIA) SYMPTOMS. A TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS PERFORMED, AND A LARGE MOBILE THROMBUS WAS NOTED ATTACHED TO THE MITRAL FACE OF THE CLOSURE DEVICE. THE PATIENT STARTED HEPARIN AND WAS REMAINED ON (B)(6) 2025 AND IT WAS NOTED THAT THE THROMBUS CHANGED AND HAS SIGNIFICANT MOVEMENT. THE PATIENT WAS REFERRED TO THE UNIVERSITY OF IOWA FOR A THROMBECTOMY PROCEDURE WITH A SENTINEL PROTECTION DEVICE. THE PROCEDURE WAS SUCCESSFUL, AND THE THROMBUS WAS ASPIRATED USING THE NON-BOSTON SCIENTIFIC (BSC) DEVICE. ALL TIA SYMPTOMS WERE TRANSIENT AND RESOLVED. THE PATIENT WAS DISCHARGED ON (B)(6) 2025 AND IS EXPECTED TO FULLY RECOVER.

  Patient problems: Thrombosis/Thrombus; Transient Ischemic Attack

  MAUDE report 23888603 ↗
• InjuryDec 18, 2025Failure to Seal; Failure to Seal

  IT WAS REPORTED THE DEVICE DID NOT SEAL. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 27MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED ON (B)(6) 2022. THE PATIENT WAS DISCHARGED. THE PATIENT REPORTED HE HAD A FOLLOW UP COMPUTED TOMOGRAPHY (CT) SCAN AFTER HIS PROCEDURE, AND WAS TOLD IT WAS FINE, BUT THEY KEPT HIM ON WARFARIN. HE EVENTUALLY SWITCHED TO PLAVIX AND 81 MG ASA ONLY YEARS AGO AND REMAINS ON THEM. THE PATIENT REPORTED THAT HE RECENTLY HAD SOME CHEST PAIN AND A CT WAS PERFORMED WHICH REVEALED A 3-5CM LEAK. THE PATIENT REPORTED THAT HE HAS A FOLLOW UP APPOINTMENT SCHEDULED TO SEE PHYSICIAN.

  Patient problems: Chest Pain

  MAUDE report 23839902 ↗
• DeathDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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. PRIOR TO IMPLANT PROCEDURE, ASPIRIN WAS ADMINISTERED. ON (B)(6) 2022, THE PATIENT UNDERWENT SUCCESSFUL PLACEMENT OF 27 MM WATCHMAN FLX DEVICE. ON (B)(6) 2022, THE PATIENT WAS DISCHARGED ON APIXABAN (10 MG/DAY), CLOPIDOGREL (75 MG/DAY) AND ASPIRIN (81 MG/DAY). ON (B)(6) 2025, 1353 DAYS POST INDEX PROCEDURE, THE PATIENT PASSED AWAY. PER EDC, THE HOME HEALTH COMPANY WAS UNABLE TO REACH THE PATIENT BY PHONE OR EMAIL SINCE (B)(6) 2025, SO THEY CONTACTED THE LOCAL POLICE DEPARTMENT TO REQUEST A WELLNESS CHECK ON THE PATIENT AND THE POLICE FOUND THE PATIENT DECEASED INSIDE HOME. AT THE TIME OF DEATH, THE PATIENT WAS ON ASPIRIN (81MG/DAY). THERE WAS NO ACTION TAKEN AND DIAGNOSTICS PERFORMED IN RESPONSE TO THE EVENT. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE, AND SITE HAS BEEN QUERIED FOR THE SAME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23768361 ↗
• InjuryNov 22, 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 27MM WATCHMAN FLX PRO CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED ON (B)(6) 2023. THE PATIENT WAS DISCHARGED. THE PATIENT STATED THAT IN (B)(6) 2024 PRIOR TO ABLATION THE PHYSICIAN NOTED A BLOOD CLOT ON CLOSURE DEVICE VIA A TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). THE PATIENT WAS ON ELIQUIS AND NOW IS ON WARFARIN. THE PATIENT STATED THAT A REPEAT TEE WAS PERFORMED AND IMAGING SHOWED THAT THE CLOT REMAINS ON THE CLOSURE DEVICE. ACCORDING TO THE PHYSICIAN THE CLOT HAS REDUCED SLIGHTLY. THE PATIENT STATED WANTING TO KNOW THE ALTERNATIVES AND WAS REFERRED BACK TO THE CARDIOLOGIST. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23625654 ↗
• InjuryNov 20, 2025Migration; Failure to Seal; Migration; Failure to Seal

  IT WAS REPORTED A CEREBRAL VASCULAR ACCIDENT (CVA) OCCURRED. THE PATIENT PREVIOUSLY UNDERWENT A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE ON (B)(6) 2021, DURING WHICH A 27MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED. POST-PROCEDURE, THE PATIENT WAS DISCHARGED ON XARELTO FOR 45 DAYS, AFTER WHICH THE MEDICATION WAS SWITCHED TO PLAVIX UNTIL THE 6-MONTH FOLLOW-UP. ON (B)(6) 2025, THE PATIENT PRESENTED TO THE HOSPITAL WITH SYMPTOMS OF SPEECH DELAY. IT WAS NOTED THAT THE PATIENT HAD A WATCHMAN DEVICE IMPLANTED IN 2021. A TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS PERFORMED, WHICH REVEALED THAT THE DEVICE WAS CANTED WITHIN THE APPENDAGE AND SHOWED RESIDUAL FLOW/LEAK OF 3-5MM PAST THE APPENDAGE. THERE WAS NO THROMBUS NOTED. THE PATIENT WAS RESTARTED ON ORAL ANTICOAGULATION (OAC) THERAPY. THE 45-DAY TEE FROM THE IMPLANTING HOSPITAL WAS REVIEWED. THE IMPLANTING PHYSICIAN DOCUMENTED THAT THE CLOSURE DEVICE APPEARED WELL-SEATED AT THE OSTIUM WITH NO FLOW AROUND IT. HOWEVER, UPON FURTHER REVIEW, THE IMAGING SUGGESTED THAT THE DEVICE WAS ALREADY CANTED AT THE OSTIUM AND LIKELY HAD FLOW BENEATH THE DEVICE, THOUGH THE ORIGINAL IMAGING QUALITY WAS SUBOPTIMAL. THERE IS NO INTERVENTION PLANNE

  Patient problems: Speech Disorder; Stroke/CVA

  MAUDE report 23607925 ↗
• InjuryNov 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DEVICE EMBOLIZATION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED A 27MM WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED ON (B)(6) 2023. THE PATIENT WAS DISCHARGED. DURING REVIEW OF THE IMPLANT PROCEDURE, IT APPEARED THAT THE CLOSURE DEVICE LEFT A SHOULDER ABOUT 1/3 THE DEVICE. THE PHYSICIAN STATED THAT DURING THE ROUTINE 45-DAY FOLLOW UP, THE CLOSURE DEVICE APPEARED ALMOST 50 PERCENT OUT BUT NO INTERVENTION OR FOLLOW UP TRANSESOPHAGEAL ECHOCARDIOGRAPHY WERE PERFORMED. THE PATIENT PRESENTED TO THE HOSPITAL ON (B)(6) 2025 WITH WEAKNESS AND DIZZINESS. HEPARIN WAS ADMINISTRATED TO THE PATIENT. THE PATIENT DID NOT HAVE ANY FOCAL NEURO DEFICITS. THE PATIENT WAS SCHEDULED FOR DEVICE EXTRACTION AND DEVICE REIMPLANTATION ON (B)(6) 2025. THE PHYSICIAN WAS CONCERNED ABOUT POSSIBLE CLOT WITHIN THE CLOSURE DEVICE AND EXTRACTION THROUGH A SHEATH WITH RELEASE OF CLOTS/MICRO CLOTS. THE HOSPITAL WAS ABLE TO OBTAIN PERMISSION FOR USE OF THE NON-BOSTON SCIENTIFIC (BSC) EMBOLINER DEVICE WHICH IS STILL BE RESEARCHED. THE CLOSURE DEVICE WAS EXTRACTED USING A NON-BSC SNARE DEVICE AND A NEW 24MM CLOSURE DEVICE WAS IMPLANTED. THE 24MM CLOSURE DEVICE DID NOT MEET PO

  Patient problems: Dizziness; Muscle Weakness/Atrophy

  MAUDE report 23511146 ↗
• InjurySep 11, 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 A CEREBRAL VASCULAR ACCIDENT OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) AND A 27MM 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 REMAINED ON ELIQUIS FOR SIX MONTHS THEN WENT TO A PLAVIX/ASPIRIN REGIMEN FOR ONE MONTH. ONE (1) YEAR POST PROCEDURE THE PATIENT SUFFERED A RIGHT SIDED BRAIN HEMORRHAGE AND SEIZURE. THE PATIENT MENTIONED THAT THE DOCTOR AT THE EMERGENCY ROOM TOLD HER THAT SHE HAD, "WHAT LOOKED LIKE A RECENT STROKE.' THE PATIENT WAS TREATED AND THEN SENT HOME ON THAT SAME DAY. PATIENT REPORTED THAT THEIR LIFESTYLE CONTINUES TO DECAY AS THEY ARE CURRENTLY EXPERIENCING LEFT-SIDED SWELLING OF THEIR UPPER AND LOWER EXTREMITIES.

  Patient problems: Convulsion/Seizure; Stroke/CVA; Swelling/ Edema

  MAUDE report 23029891 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTED VIA CLINICAL STUDY. IT WAS REPORTED AN ACUTE CORTICAL INFARCT OCCURRED. A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE WAS PERFORMED. A 27MM WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WAS IMPLANTED ON (B)(6) 2021 WITH COMPLETE LAA SEAL AND A DEPLOYED DEVICE DIAMETER OF 22 MM. THE PATIENT WAS DISCHARGED THE SAME DAY ON A MEDICATION REGIME OF APIXABAN (10 MG/DAY) AND ASPIRIN (81 MG/ DAY). ON (B)(6) 2024, 1162 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED TO EMERGENCY DEPARTMENT (ED) DUE TO LEFT ARM NUMBNESS AND LOSS OF BALANCE. CARDIAC IMAGING, ELECTROCARDIOGRAM (ECG) AND LAB TESTS WERE PERFORMED. BRAIN IMAGING PERFORMED REVEALED ACUTE CORTICAL INFARCT. THE PATIENT WAS ON ASPIRIN (81 MG/ DAY) AT THE TIME OF REPORTING. ON (B)(6) 2024, THE OUTCOME OF THE EVENT WAS CONSIDERED TO BE RESOLVED. ON (B)(6) 2024, THE PATIENT WAS STARTED ON APIXABAN (10 MG/DAY) IN RESPONSE TO THE EVENT. ON (B)(6) 2025, THE DOSAGE OF APIXABAN (10MG/DAY) WAS REDUCED TO APIXABAN (5 MG/DAY).

  Patient problems: Stroke/CVA

  MAUDE report 22977663 ↗
• DeathAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A PATIENT DEATH. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) AND A 27MM 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. TWO (2) YEARS POST PROCEDURE THE PATIENT WAS ADMITTED TO THE HOSPITAL AFTER EXPERIENCING A CEREBRAL VASCULAR ACCIDENT. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING SHOWED THAT THERE WAS A DEVICE RELATED THROMBUS. THE PATIENT DID NOT RECOVER AND ULTIMATELY THE PATIENT DIED AS A RESULT OF THIS EVENT.

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 22853475 ↗
• InjuryAug 19, 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 (CVA). A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. ON (B)(6) 2022 THE PATIENT UNDERWENT SUCCESSFUL PLACEMENT OF A 27 MM WATCHMAN FLX DEVICE WITH COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 22 MM. ON (B)(6) 2022, THE PATIENT WAS DISCHARGED ON ASPIRIN (81 MG /DAY) AND CLOPIDOGREL (75 MG/DAY). ON (B)(6) 2025, 1002 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED TO EMERGENCY ROOM (ER) WITH COMPLAINTS OF LEFT FACE-SIDED WEAKNESS, FACIAL DROOP, AND LOSS OF SENSATION. A COMPUTED TOMOGRAPHY (CT) SCAN OF THE BRAIN WAS PERFORMED FOR FURTHER EVALUATION. ADDITIONALLY, VENOUS DUPLEX ULTRASOUND, X-RAY AND LABORATORY TESTS WERE ALSO PERFORMED. AT THE TIME OF THE EVENT, THE PATIENT WAS ON ASPIRIN (81 MG /DAY). IT WAS REPORTED THE EVENT OF A CVA OCCURRED. ON THE SAME DAY, NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) WAS PERFORMED, AND THE SCORE WAS NOTED TO BE 12. ON (B)(6) 2025, MODIFIED RANKIN SCALE (MRS) WAS PERFORMED, AND THE SCORE WAS NOTED TO BE 0 WITH NO SYMPTOMS. ON (B)(6) 2025, ASPIRIN WAS STOPPED, AND THE PATIENT WAS STARTED WITH APIXABAN (10 MG/DAY) FOR S

  Patient problems: Facial Paralysis; Stroke/CVA

  MAUDE report 22844097 ↗
• DeathJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT SUMMARIZES 2 DEATH 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. 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 DA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22666957 ↗
• InjuryJul 24, 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 27MM WATCHMAN FLX CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED IN 2023. THE PATIENT WAS DISCHARGED. IN (B)(6) 2025, THE PATIENT WAS SCHEDULED FOR AN ATRIAL FIBRILLATION ABLATION. AFTER INTUBATION, A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED A THROMBUS ON THE CLOSURE DEVICE, AND THE PROCEDURE WAS THEREFORE CANCELED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22588637 ↗
• DeathJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT SUMMARIZES 1 DEATH EVENTS 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 PREVIO

  Patient problems: Unspecified Infection

  MAUDE report 22587725 ↗
• 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 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. 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 PREVIOUSLY REPOR

  Patient problems: Endocarditis

  MAUDE report 22587670 ↗

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,