WATCHMAN® M635WU24060Recalls & reported problems

Summary

The FDA's MAUDE database contains 420 adverse event reports that list this exact device (DI 08714729838234), received between Nov 15, 2016 and Apr 17, 2026 — classified as 26 deaths, 368 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (17 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 420 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  REPORTED VIA PATIENT CALL CENTER. IT WAS REPORTED THAT CEREBRAL VASCULAR ACCIDENT OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 24MM WATCHMAN DELIVERY SYSTEM (WDS) WAS IMPLANTED ON (B)(6) 2018. THE PATIENT WAS DISCHARGED. THE PATIENT'S WIFE STATED THAT THE PATIENT HAD A STROKE ON (B)(6) 2024. THE PATIENT WAS TAKING BABY ASPIRIN PRIOR THE PROCEDURE AND AFTER THE IMPLANT OF THE CLOSURE DEVICE. THE PATIENT CONTINUES TO TAKE IT, WITH NO OTHER BLOOD THINNER PRESCRIBED. IT WAS STATED THAT THE PATIENT DID NOT HAVE ANY FOLLOW UP TESTING DONE AFTER THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Stroke/CVA

  MAUDE report 24916456 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED CEREBRAL VASCULAR ACCIDENT (CVA) AND THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 24MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED IN (B)(6) 2020. THE PATIENT WAS DISCHARGED ON WARFARIN AND ASPIRIN (ASA) 81MG. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) PERFORMED ON (B)(6) 2020 NOTED NO THROMBUS ON THE DEVICE OR LEAK AND NO POSITION CHANGE. THE PATIENT WAS TRANSITIONED TO DUAL ANTIPLATELET THERAPY (DAPT). CLOPIDOGREL WAS DISCONTINUED ON (B)(6) 2021, AND PATIENT CONTINUED ASA 81MG DAILY. ON (B)(6) 2023, THE PATIENT WAS EVALUATED FOR RIGHT SIDED WEAKNESS AND DIAGNOSED WITH STROKE (LACUNAR INFARCT) ON (B)(6) 2023. NO TEE WAS COMPLETED AT THIS TIME. THE PATIENT WAS SEEN BY NEUROLOGY WHO FELT THAT IT WAS UNLIKELY CARDIOEMBOLIC. ECHOCARDIOGRAM PERFORMED ON (B)(6) 2025 MADE NO MENTION OF THE DEVICE OR PROBLEMS SEEN ON THE DEVICE. ON (B)(6) 2026, THE PATIENT PRESENTED TO THE EMERGENCY ROOM FOR EVALUATION OF SHORTNESS OF BREATH AND A COUGH. COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) OF PULMONARY ARTERIES WAS COMPLETED TO RULE OUT PERICARDIAL EFFUSION. NO EFFUSION WAS PRESENT, BUT THERE WAS SUSPICIOUS DENSE TISSUE AROUND THE CLOSURE DEVICE. ON

  Patient problems: Cough; Dyspnea; Muscle Weakness/Atrophy; Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 24393314 ↗
• InjuryAug 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DEVICE EMBOLIZATION OCCURRED. 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. THERE WERE NO PATIENT COMPLICATIONS THAT WERE REPORTED TO HAVE OCCURRED. FIVE (5) YEARS POST PROCEDURE IT WAS DISCOVERED THAT THE CLOSURE DEVICE HAD EMBOLIZED OUT OF THE LAA. THE CLOSURE DEVICE WAS FOUND IN THE DESCENDING AORTA AND BLOCKING THE RENAL ARTERIES. AN INTERVENTIONAL RADIOLOGIST SUCCESSFULLY REMOVED THE CLOSURE DEVICE FROM THE PATIENT PERCUTANEOUSLY. THERE WERE NO OTHER COMPLICATIONS THAT WERE REPORTED TO HAVE OCCURRED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22853470 ↗
• InjuryJun 24, 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 TRANSIENT ISCHEMIC ATTACK. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. THE PATIENT UNDERWENT SUCCESSFUL PLACEMENT OF A 24MM WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) DEVICE WITH COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 21MM. THE PATIENT WAS DISCHARGED ON CLOPIDOGREL AND ASPIRIN ON (B)(6) 2020. ON (B)(6) 2025, 1809 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF DIFFICULTY IN FINDING WORDS, CONFUSION, FEELING UNWELL AND REPORTED SOME VAGUE NUMBNESS OF LOWER EXTREMITY. IN THE EMERGENCY DEPARTMENT, PHYSICAL EXAMINATION AND REVIEW OF SYSTEM SHOWED UNREMARKABLE CHANGES. ADDITIONALLY, A NEUROLOGICAL EXAMINATION REVEALED THE PATIENT TO BE ALERT. ON THE SAME DAY NIH STROKE SCALE WAS 3 AND CLINICAL EXAMINATION REVEALED SLIGHT LEFT SIDED FACIAL DROOP, ACCOMPANIED BY MILD APHASIA AND MILD DYSARTHRIA. A COMPUTED TOMOGRAPHY (CT) SCAN OF THE HEAD WITHOUT CONTRAST WAS PERFORMED AND REVEALED NO ACUTE INTRACRANIAL ABNORMALITY. THERE WAS A SMALL AREA OF CHRONIC PRIOR INFARCTION INVOLVING THE LEFT CEREBELLAR HEMISPHERE AND THE LEFT FRONTAL LOBE. T

  Patient problems: Confusion/ Disorientation; Facial Paralysis; Numbness; Speech Disorder; Transient Ischemic Attack

  MAUDE report 22319644 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTED VIA PATIENT CALL CENTER IT WAS REPORTED VIA THE WATCHMAN PATIENT CALL CENTER THAT A PATIENT EXPERIENCED TWO STROKES. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 24MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED ON (B)(6) 2020. THE PATIENT REPORTED THAT SINCE HAVING THE WATCHMAN PLACED, HE HAS HAD TWO SMALL STROKES. THE PATIENT STATED THAT HE DOES NOT RECALL HAVING ANY FOLLOW UP TESTING AFTER HIS PROCEDURE. THE PATIENT STATED HE CONTINUED TAKING ELIQUIS UNTIL 2022 WHEN HE HAD TO STOP IT FOR A PROSTATE SURGERY AND HE NEVER RESTARTED IT AFTER THE PROSTATE PROCEDURE. THE PATIENT REPORTED HE THEN HAD A SMALL STROKE AND HAD ANOTHER ONE IN (B)(6) 2024 AND WAS THEN PUT BACK ON ELIQUIS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Stroke/CVA

  MAUDE report 21980571 ↗
• InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 24 MM WATCHMAN LAA CLOSURE DEVICE AND 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. FIVE (5) YEARS POST PROCEDURE THE PATIENT UNDERWENT A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING PROCEDURE. THE IMAGING SHOWED THAT THERE WAS A DEVICE RELATED THROMBUS PRESENT ON THE POSTERIOR SIDE OF THE CLOSURE DEVICE. THE PHYSICIAN RESTARTED THE PATIENT ON COUMADIN IN RESPONSE TO THIS EVENT WITH A PLAN TO PERFORM A FOLLOW UP TEE AT A FUTURE DATE. THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY AND DID NOT EXPERIENCE ANY OTHER COMPLICATIONS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21327451 ↗
• InjuryJan 23, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED VIA LITERATURE THAT THE CLOSURE DEVICE DID NOT SEAL. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 24MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) PERFORMED 45 DAYS POST PROCEDURE SHOWED A PERI-DEVICE LEAK AROUND THE WATCHMAN CLOSURE DEVICE. THE PATIENT WAS PLACED ON ANTICOAGULATION IN RESPONSE TO THE LEAK. REPEATED TEE SHOWED PERSISTENT RESIDUAL PERI-DEVICE LEAK WITH 5MM WIDTH ALONG THE COUMADIN RIDGE ASPECT OF THE WATCHMAN CLOSURE DEVICE. COMPUTED TOMOGRAPHY (CT) ALSO SHOWED A PERI-DEVICE LEAK WITH A WIDTH OF 6MM AND COMPLETE OPACIFICATION OF THE LAA. CT SHOWED THAT THE WATCHMAN CLOSURE DEVICE WAS DISPLAYED AT THE DISTAL SIDE OF THE LAA, LEAVING THE PROXIMAL SECTION OF THE LAA WITH A LENGTH OF 10MM FROM THE OSTIUM. THE PATIENT WAS REFERRED FOR MANAGEMENT OF THE PERI-DEVICE LEAK APPROXIMATELY THREE YEARS POST IMPLANT. UNDER GENERAL ANESTHESIA, AN ANGIOGRAM OF THE LEFT ATRIUM WAS PERFORMED AFTER TRANSSEPTAL PUNCTURE. BASED ON THE MEASUREMENTS OF THE PROXIMAL AND OSTIUM SECTIONS OF THE LAA, A 22MM NON-BOSTON SCIENTIFIC (BSC) CLOSURE DEVICE WAS SELECTED TO CLOSE THE PERI-DEVICE LEAK AND WAS ADVANCED INTO THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18567375 ↗
• InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING EVENT ORIGINATED FROM SOCIAL MEDIA, 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 STROKE OCCURRED. A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE WAS PERFORMED AND A WATCHMAN CLOSURE DEVICE WAS IMPLANTED IN (B)(6) 2020. IN (B)(6) 2021, THE PATIENT EXPERIENCED A MILD CLUSTER STROKE AND THEIR PRE-EXISTING ATRIAL FIBRILLATION PERSISTED. IN (B)(6) 2023, CARDIAC ABLATION WAS PERFORMED AND IN (B)(6) 2023 CARDIOVERSION WAS PERFORMED. THE PATIENT EXPERIENCED ATRIAL FLUTTER WHICH WAS TREATED WITH CARDIAC ABLATION IN (B)(6) 2023. THE PATIENT'S ATRIAL FIBRILLATION HAS STOPPED SINCE THEN AND NORMAL SINUS RHYTHM HAS BEEN RESTORED.

  Patient problems: Stroke/CVA

  MAUDE report 17980531 ↗
• InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING EVENT ORIGINATED FROM SOCIAL MEDIA, 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 A CEREBRAL VASCULAR ACCIDENT OCCURRED. A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE WAS PERFORMED, AND A WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED. SEVERAL YEARS LATER THE PATIENT EXPERIENCED FIVE (5) STROKES. IT WAS FURTHER REPORTED THAT OVER THREE (3) YEARS POST-IMPLANT THE PATIENT EXPERIENCED HALLUCINATIONS AND WAS EVALUATED VIA MAGNETIC RESONANCE IMAGING (MRI) WHERE IT WAS DETERMINED THAT THE PATIENT HAD BEEN EXPERIENCING STROKES.

  Patient problems: Stroke/CVA

  MAUDE report 17821273 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL OCCLUSION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A WATCHMAN CLOSURE DEVICE WAS IMPLANTED. APPROXIMATELY FOUR (4) YEARS POST-IMPLANT THE PATIENT EXPERIENCED COMPRESSION OF THE CIRCUMFLEX ARTERY WHICH THE PHYSICIAN SUSPECTS IS BEING CAUSED BY THE IMPLANTED WATCHMAN CLOSURE DEVICE.

  Patient problems: Chest Pain; Obstruction/Occlusion

  MAUDE report 17364668 ↗
• DeathMar 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CRANIAL HEMORRHAGE OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED USING A 24MM WATCHMAN LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS). DURING RECOVERY THE PATIENT DID NOT REGAIN CONSCIOUSNESS. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT AND CRANIAL IMAGING WAS COMPLETED. A CRANIAL BLEED, ATTRIBUTED TO THE HEPARIN ADMINISTERED DURING THE INDEX PROCEDURE, WAS IDENTIFIED AND THE BLOOD DRAINED. IT WAS FURTHER REPORTED THE PATIENT DIED PRIOR TO DISCHARGE AFTER INDEX PROCEDURE.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 16590712 ↗
• InjuryAug 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA THE PATIENT CALL CENTER THAT A TRANSIENT ISCHEMIC ATTACK (TIA) OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. ABOUT THREE YEARS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED A TIA. THE PATIENT WAS PLACED ON PLAVIX AND WAS TAKEN OFF THE ASPIRIN MEDICATION REGIMEN. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Transient Ischemic Attack

  MAUDE report 15300190 ↗
• InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TRANSIENT ISCHEMIC ACCIDENT OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. A 24MM WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS) WAS USED. PRIOR TO THE PROCEDURE THE PATIENT WAS NOT TAKING ANY ANTIPLATELET THERAPY. DURING THE IMPLANT PROCEDURE A CLOSURE DEVICE WAS PLACED BUT THE POSITION WAS TOO PROXIMAL SO THIS DEVICE WAS REMOVED AND A SECOND DEVICE WAS SUCCESSFULLY PLACED. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS DISCHARGED WITH PRESCRIPTIONS FOR (B)(6) AND CLOPIDOGREL. THE PATIENT EXPERIENCED A SEIZURE ON 18DECEMBER2019 AND 29JUNE2021. ON (B)(6) 2021, 1142 DAYS POST IMPLANT PROCEDURE, THE PATIENT EXPERIENCED SLURRED SPEECH, RIGHT SIDED FACIAL DROOP, AND FATIGUE. UPON ARRIVAL IN THE EMERGENCY DEPARTMENT, PHYSICAL EXAMINATION REVEALED NO SIGNIFICANT FINDINGS WITH NORMAL MOTOR, SENSORY AND CRANIAL NERVE FUNCTION. NEUROLOGY CONSULTATION RECOMMENDED FOR CT SCAN OF HEAD, NECK, AND CT PERFUSION AND SUSPECT FOR TRANSIENT ISCHEMIC ATTACK. ON THE SAME DAY, CT SCAN REVEALED NO ACUTE INFRACT, NO INTRACRANIAL HEMORRHAGE, NO EFFECTIVE MASS, CHRONIC THIN BILATERAL HEMATOMA. ON (B)(6) 2021, CT OF ANGIO NECK REVEALED NO STENOSIS

  Patient problems: Transient Ischemic Attack

  MAUDE report 13258806 ↗
• InjuryJan 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS ENROLLED IN THE (B)(6) STUDY ON (B)(6) 2019 WITH PATIENT IDENTIFIER (B)(6). IT WAS REPORTED THAT STROKE OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 24MM WATCHMAN LAA CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED WITH 0.2MM JET SIZE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 21MM. PRIOR TO THE PROCEDURE, ASPIRIN AND CLOPIDOGREL WERE ADMINISTERED AND AFTER THE IMPLANT PROCEDURE THEY WERE CONTINUED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE NEXT DAY. 851 DAYS POST-WATCHMAN IMPLANT PROCEDURE, THE PATIENT EXPERIENCED RIGHT ARM DYSMETRIA AND SIGNS OF LEFT-SIDED STROKE. THE PATIENT WAS HOSPITALIZED. COMPUTED TOMOGRAPHY (CT) OF THE HEAD/NECK AND CT OF THE HEAD/BRAIN WITHOUT CONTRAST REVEALED NO ACUTE HEMORRHAGE, SCATTERED LEFT DEEP INFARCTS SOME OF WHICH WERE NEW FROM 2019 AND CHRONIC MICROVASCULAR ISCHEMIC CHANGES. THE PATIENT WAS NOTED WITH NO LARGE VESSEL OCCLUSIONS. FOUR DAYS LATER, THE PATIENT UNDERWENT MAGNETIC RESONANCE IMAGING (MRI) OF THE BRAIN WITHOUT CONTRAST WHICH REVEALED NUMEROUS SMALL ACUTE TO SUBACUTE INFARCTS IN A PREDOMINATELY LEFT-SIDED WATERSHED DISTRIBUTION, MODERATE SMALL VESSEL ISCHEMIC DISEASE, AND MULTIPLE PREDOMIN

  Patient problems: Ischemia Stroke; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13191350 ↗
• InjuryDec 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASAP TOO STUDY. IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. PRIOR TO THE INDEX PROCEDURE, ASPIRIN WAS ADMINISTERED AND AFTER THE IMPLANT PROCEDURE THE PATIENT WAS STARTED ON CLOPIDOGREL, ASPIRIN WAS CONTINUED. THE PATIENT UNDERWENT SUCCESSFUL PLACEMENT OF A 24 MM WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICE WITH COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 17 MM. ONE DAY POST INDEX PROCEDURE, THE PATIENT WAS DISCHARGED. ON (B)(6) 2017, 85 DAYS POST INDEX PROCEDURE AT THE 3 MONTH FOLLOW-UP VISIT, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED A THROMBUS ON THE ATRIAL FACING SURFACE OF THE DEVICE. OF NOTE, DURING 3-MONTH CORE LAB TEE FOLLOW-UP VISIT THE THROMBUS WAS NOTED, HOWEVER, PER SITE NO THROMBUS WAS NOTED. THE SIZE OF THE MAXIMUM AREA OF DEVICE THROMBUS 0.42 CM2 AND THE THROMBUS WAS NON MOBILE. DURING THIS TIME, THE PATIENT WAS ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2018, DURING THE 12 MONTH FOLLOW-UP VISIT NO THROMBUS WAS NOTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13051695 ↗
• InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A SUSPECTED TRANSIENT ISCHEMIC ATTACK (TIA) AND A THROMBUS. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 24MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. 233 DAYS POST INDEX PROCEDURE, THE PATIENT HAD A SUSPECTED TIA. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED A DEVICE RELATED THROMBUS ON THE WATCHMAN DEVICE. ADDITIONAL MEDICATION WAS ADMINISTERED TO TREAT THE EVENT. A FOLLOW-UP TEE WILL BE CONDUCTED IN 3 MONTHS.

  Patient problems: Thrombosis/Thrombus; Transient Ischemic Attack

  MAUDE report 12591158 ↗
• InjurySep 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A TRANSIENT ISCHEMIC ATTACK (TIA). A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 24MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE PROCEDURE WENT AS PLANNED AND WAS SUCCESSFULLY COMPLETED WITH A CLOSURE DEVICE IMPLANTED IN THE LAA OF THE PATIENT. THERE WERE NO COMPLICATIONS THAT WERE REPORTED TO HAVE OCCURRED. 25 MONTHS POST PROCEDURE THE PATIENT HAD A TIA. IT WAS NOTED THAT THE PATIENT HAS CAROTID DISEASE AND THE TIA IS BELIEVED TO BE RELATED TO THAT PER THE PHYSICIAN. THE PATIENT WAS ON PLAVIX AND LOW DOSE ASPIRIN AT THE TIME OF THE EVENT.

  Patient problems: Transient Ischemic Attack

  MAUDE report 12417966 ↗
• InjuryAug 12, 2021Migration; Migration

  IT WAS REPORTED THAT A MOVEMENT/SHIFT OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 24MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. AT THE PATIENT'S 45 DAY FOLLOW UP APPOINTMENT, TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IDENTIFIED THAT THE CLOSURE DEVICE WAS VERY PROXIMAL IN POSITION. THE FEET OF THE CLOSURE DEVICE WERE STILL IN THE LAA, HOWEVER, THE PHYSICIAN FELT THE PATIENT RAN A RISK OF DEVICE EMBOLIZATION. THE CLOSURE DEVICE WAS EXPLANTED FROM THE PATIENT WITH A 16 FRENCH SHEATH AND A SNARE. THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY. THE PATIENT PLANS TO RETURN AT THE END OF (B)(6) 2021 FOR ANOTHER WATCHMAN IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12313608 ↗
• InjuryAug 11, 2021Adverse 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 LAA CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE SEAL. ON (B)(6) 2020, AT THE 45-DAY FOLLOW UP, TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IMAGING SHOWED NO THROMBOSIS AND THE PATIENT WAS TAKEN OFF XARELTO AND SWITCHED TO DUAL ANTIPLATELET THERAPY (DAPT) WITH PLAVIX AND ASPIRIN. THE PATIENT REMAINED ON DAPT UNTIL (B)(6) 2021 WHICH WAS 6-MONTHS POST-IMPLANT. ON (B)(6) 2021, AT THE ONE-YEAR FOLLOW UP, A THROMBUS WAS NOTED ON THE FACE OF THE DEVICE VIA TEE. THE PATIENT DENIED ANY STROKE-LIKE SYMPTOMS. THE PATIENT WAS PLACED ON ELIQUIS AND 81MG ASPIRIN DAILY. A FOLLOW-UP TEE WILL BE PERFORMED IN TWO TO THREE MONTHS. NO ADDITIONAL INFORMATION IS KNOWN AT THIS TIME.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12309704 ↗
• InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 24MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. SIX MONTHS POST INDEX PROCEDURE, THE PATIENT HAD A SMALL THROMBUS ON THE SURFACE OF THE CLOSURE DEVICE. THE PATIENT WAS TAKEN OFF THEIR PLAVIX REGIMEN AND WAS PLACED BACK ON ELIQUIS. THE PATIENT HAD ANOTHER TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) PERFORMED ON (B)(6) 2021, WHICH STILL SHOWED THROMBUS ON THE DEVICE. THE PATIENT CONTINUED THEIR ELIQUIS DRUG REGIMEN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12144360 ↗
• InjuryJul 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 24MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE CLOSURE DEVICE WAS DEPLOYED IN THE LAA OF THE PATIENT, BUT THE DEVICE WAS TOO PROXIMAL, SO THE PHYSICIAN FULLY RECAPTURED AND REMOVED IT FROM THE PATIENT. THE WAS WAS REPOSITIONED TO BE DEEPER INTO THE APPENDAGE AND A NEW 24MM CLOSURE DEVICE WAS SELECTED FOR USE. THIS NEW DEVICE WAS DEPLOYED IN THE LAA AND WHILE THE RELEASE CRITERIA WAS BEING CHECKED THE PATIENT HAD A DROP IN THEIR BLOOD PRESSURE. A CONTRAST INJECTION WAS GIVEN AND IT WAS NOTED THAT THE PATIENT HAD A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO DRAIN 325CC OF FLUID FROM THE PATIENT. AT THE SAME TIME THE RELEASE CRITERIA WAS CHECKED AND THE CLOSURE DEVICE WAS RELEASED FROM THE CORE WIRE. THE PATIENT WAS GIVEN PROTAMINE TO TREAT THE EFFUSION AFTER THE DEVICE WAS RELEASED. THE DRAIN WAS LEFT IN PLACE AND THE PATIENT WAS BROUGHT TO THE INTENSIVE CARE UNIT FOR OBSERVATION SINCE THE EFFUSION HAD DECREASED. LATER THAT DAY THE PATIENT WAS EXTUBATED, AWAKE AND OFF PR

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 12121099 ↗
• InjuryJun 21, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT A CEREBRAL VASCULAR ACCIDENT (CVA) OCCURRED AND THAT THE CLOSURE DEVICE DID NOT SEAL. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 24MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. ONLY ONE PARTIAL RECAPTURE WAS PERFORMED PRIOR TO SUCCESSFUL IMPLANTATION OF THE CLOSURE DEVICE. ON FOLLOW UP TRANSESOPHAGEAL ECHOCARDIOGRAPHY IN NOV2020, A 6MM GAP WAS NOTED ON THE MITRAL SIDE OF THE CLOSURE DEVICE. ON 01MAR2021, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CRYPTOGENIC STROKE. NO ADDITIONAL INFORMATION IS KNOWN AT THIS TIME.

  Patient problems: Stroke/CVA

  MAUDE report 12033315 ↗
• InjuryJun 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse 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 AND A WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. IN (B)(6) 2020, THE PATIENT HAD A STROKE AND WAS PRESCRIBED WARFARIN. THE PATIENT WAS IN THE PROCESS OF SETTING UP ANOTHER MAGNETIC RESONANCE IMAGING (MRI) APPOINTMENT.

  Patient problems: Stroke/CVA

  MAUDE report 11991325 ↗
• InjuryJun 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CEREBRAL VASCULAR ACCIDENT (CVA) OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 24MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED UNEVENTFULLY. IN (B)(6) 2021, AT THE 45-DAY FOLLOW-UP TRANSESOPHAGEAL ECHO (TEE), THE DEVICE WAS NOTED TO BE PROPERLY SEATED AND WITHOUT DEVICE RELATED THROMBUS. THE PATIENT WAS TAKEN OFF THEIR ORAL ANTICOAGULATION AND MOVED TO ANTIPLATELET THERAPY. ON (B)(6) 2021, THE PATIENT PRESENTED WITH AN EMBOLIC CVA TO AN ALTERNATE FACILITY FROM THE IMPLANT FACILITY. IT IS UNKNOWN IF THE PATIENT WAS COMPLIANT WITH THEIR MEDICATION REGIMEN. THE PATIENT CONTINUES TO HAVE SPEECH DIFFICULTIES.

  Patient problems: Stroke/CVA

  MAUDE report 11939922 ↗
• InjuryJun 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASAP TOO STUDY. IT WAS REPORTED THAT A CEREBRAL VASCULAR ACCIDENT (CVA) AND THROMBOSIS OCCURRED. THE PATIENT WAS ON ASPIRIN PRIOR TO THE INDEX PROCEDURE. ON (B)(6) 2020, A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 24MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 21MM. AFTER THE IMPLANT, THE PATIENT WAS STARTED ON CLOPIDOGREL. THE POST IMPLANT TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED A COMPLETE LAA SEAL. THE PATIENT WAS DISCHARGED ON (B)(6) 2020. ON (B)(6) 2021, 319 DAYS POST INDEX PROCEDURE, THE PATIENT WAS DIAGNOSED WITH A STROKE. THE PATIENT WAS ON ASPIRIN AND CLOPIDOGREL AT THE TIME OF THE EVENT. THE DURATION OF FOCAL OR GLOBAL NEUROLOGICAL DEFICIT WAS GREATER THAN 24 HOURS IN THE OF IMAGING-DOCUMENTED NEW HEMORRHAGE OR INFARCT. ON (B)(6) 2021, THE NATIONAL INSTITUTES OF HEALTH (NIH) STROKE SCALE WAS 1. THE BASELINE NIH STROKE SCALE THAT WAS PERFORMED ON (B)(6) 2020 WAS 0. ON (B)(6) 2021, 321 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED TO THE ENROLLING SITE FOR A 12 MONTH FOLLOW UP, WHICH REVEALED THROMBUS ON THE DEVICE AND WORSENED LEAK OF 4MM AROUND THE WATCHMAN DEVICE. IT WAS FURTHER REPO

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 11922782 ↗

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