WATCHMAN® M635WU33060Recalls & reported problems

Summary

The FDA's MAUDE database contains 269 adverse event reports that list this exact device (DI 08714729838265), received between Dec 7, 2016 and Oct 31, 2025 — classified as 16 deaths, 210 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (29 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 269 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 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 33MM WATCHMAN CLOSURE DEVICE WAS IMPLANTED ON (B)(6) 2020. THE PATIENT WAS DISCHARGED. THE PATIENT HAD A ROUTINE FIVE (5) YEAR FOLLOW UP COMPUTED TOMOGRAPHY (CT) SCAN WITH A NEW CARDIOLOGIST. CT SHOWED THE CLOSURE DEVICE DISTAL IN THE LAA WITH CONTRAST FILLING INTO THE DISTAL END OF THE APPENDAGE AND POTENTIAL UNCOVERED LAA TISSUE. THE PATIENT HAD NO MEDICAL CONCERNS PRIOR TO LEAK FIND. THE PATIENT WAS PLACED BACK ON ORAL ANTICOAGULATION (OAC) MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439483 ↗
• InjuryMay 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE ARTICLE THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED USING A 33MM WATCHMAN LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS). WHEN THE WDS WAS ADVANCED INTO THE ANATOMY, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED SPONTANEOUS ECHO CONTRAST IN THE LEFT ATRIAL APPENDAGE. INTRAVENOUS HEPARIN WAS ADMINISTERED. IMMEDIATELY FOLLOWING DEPLOYMENT, A THROMBUS MEASURING 11.6 X 4.4MM WAS OBSERVED ON THE CLOSURE DEVICE. THE WDS WAS USED TO SUCCESSFULLY ASPIRATE THE THROMBUS AND THE CLOSURE DEVICE WAS RECAPTURED AND REMOVED FROM THE PATIENT. THE PROCEDURE WAS ABORTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19239475 ↗
• InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A STROKE OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 33MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. IN 2022, THE PATIENT EXPERIENCED A STROKE. NO FURTHER INFORMATION SURROUNDING THE STROKE WAS AVAILABLE. ON (B)(6) 2024, THE PATIENT WAS ADMITTED FOR ATRIAL FIBRILLATION. THE PHYSICIANS PERFORMED DIRECT CURRENT CARDIOVERSION (DCCV) IN RESPONSE TO THE ATRIAL FIBRILLATION ON (B)(6) 2024. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS PERFORMED ON (B)(6) 2024, AND THE CLOSURE DEVICE APPEARED TO HAVE HAD EITHER A TEAR IN THE MIDDLE OF THE FABRIC OR A FLUTTERING FABRIC CAP. THE CLOSURE DEVICE APPEARED TO HAVE SHIFTED ONLY SLIGHTLY PROXIMAL SINCE 2018. NO INTERVENTION WAS PLANNED IN RESPONSE TO THE TEAR IN THE FABRIC OR FLUTTERING FABRIC CAP. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Confusion/ Disorientation; Muscle Weakness/Atrophy; Speech Disorder; Stroke/CVA; Transient Ischemic Attack

  MAUDE report 18740332 ↗
• MalfunctionFeb 20, 2024Material Integrity Problem; Migration; Material Integrity Problem; Migration

  IT WAS REPORTED THAT A TEAR IN THE FABRIC OF THE CLOSURE DEVICE OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 33MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. IN 2022, THE PATIENT EXPERIENCED A STROKE. NO FURTHER INFORMATION SURROUNDING THE STROKE WAS AVAILABLE. ON (B)(6)2024, THE PATIENT WAS ADMITTED FOR ATRIAL FIBRILLATION. THE PHYSICIANS PERFORMED DIRECT CURRENT CARDIOVERSION (DCCV) IN RESPONSE TO THE ATRIAL FIBRILLATION ON (B)(6)2024. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS PERFORMED ON (B)(6) 2024, AND THE CLOSURE DEVICE APPEARED TO HAVE HAD EITHER A TEAR IN THE MIDDLE OF THE FABRIC OR A FLUTTERING FABRIC CAP. THE CLOSURE DEVICE APPEARED TO HAVE SHIFTED ONLY SLIGHTLY PROXIMAL SINCE 2018. NO INTERVENTION WAS PLANNED IN RESPONSE TO THE TEAR IN THE FABRIC OR FLUTTERING FABRIC CAP. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18740159 ↗
• InjuryNov 3, 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 PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE WAS PERFORMED, AND A WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED. AT AN UNSPECIFIED TIME, POST-DISCHARGE, THE PATIENT WAS TRANSFERRED VIA AMBULANCE TO THE SAME HOSPITAL THAT THE IMPLANT PROCEDURE TOOK PLACE. THE PATIENT WAS BROUGHT TO THE CATHETERIZATION LABORATORY AND THE PATIENT'S BLOOD PRESSURE WAS NOT REGISTERING. A PERICARDIAL EFFUSION WAS IDENTIFIED AND A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT IS DOING WELL NOW WITH NO FURTHER COMPLICATIONS AND IS OFF THEIR XARELTO. IT WAS FURTHER REPORTED THAT THE PATIENT WAS TRANSFERRED VIA AMBULANCE BACK TO THE HOSPITAL THE DAY AFTER THE PROCEDURE.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 18068395 ↗
• DeathJun 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT DEATH OCCURRED. IN (B)(6) 2020, A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 33MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. IN (B)(6) 2023, THE PATIENT EXPERIENCED A STROKE AND DIED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. IT WAS FURTHER REPORTED THE PATIENT EXPERIENCED HEADACHE AND VOMITING PRIOR TO BEING HOSPITALIZED IN (B)(6)2023. THE PATIENT CAUSE OF DEATH WAS IDENTIFIED AS A RIGHT M1 OCCLUSION OF THE MIDDLE CEREBRAL ARTERY AND A LARGE, HEMORRHAGIC, ACUTE INFARCT OF THE RIGHT CEREBRAL HEMISPHERE.

  Patient problems: Headache; Stroke/CVA; Vomiting

  MAUDE report 17127442 ↗
• InjuryMar 3, 2023Adverse 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 WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED. APPROXIMATELY 2 1/2 YEARS POST-IMPLANT, A THROMBUS WAS OBSERVED ATTACHED TO THE CLOSURE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS KNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16480660 ↗
• InjuryDec 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse 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 33MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED TO BE USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE CLOSURE DEVICE IMPLANTED IN THE LAA OF THE PATIENT. IT WAS REPORTED AT AN UNKNOWN DATE POST PROCEDURE THE PATIENT EXPERIENCED A CEREBRAL VASCULAR ACCIDENT. THE PATIENT RECEIVED TREATMENT AND HAS SINCE FULLY RECOVERED FROM THIS EVENT WITH NO RESIDUAL DEFICITS.

  Patient problems: Stroke/CVA

  MAUDE report 16001754 ↗
• InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASAP TOO STUDY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A TRANSIENT ISCHEMIC ATTACK. PRIOR TO THE PROCEDURE, THE PATIENT WAS ON ASPIRIN AND CLOPIDOGREL. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) AND A 33MM WATCHMAN 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 SEAL AND A DEPLOYED DEVICE DIAMETER OF 28.2 MM. POST IMPLANT PROCEDURE CLOPIDOGREL WAS CONTINUED. FIVE (5) YEARS POST PROCEDURE THE PATIENT PRESENTED TO THE HOSPITAL WITH PERIORAL NUMBNESS, SLIGHT RIGHT SIDED FACIAL DROOP, AND WORSENING OF RIGHT ARM WEAKNESS. THE PATIENT AT THE TIME WAS NOT ON ANY ANTICOAGULATION MEDICATION. ON THE SAME DAY, A COMPUTED TOMOGRAPHY (CT) HEAD, CT HEAD/NECK WERE NEGATIVE. ADDITIONALLY, A CHEST X-RAY WAS ALSO PERFORMED. THE FOLLOWING DAY, MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED, AND IT WAS NEGATIVE. THE PATIENT WAS DIAGNOSED WITH A TRANSIENT ISCHEMIC ATTACK. THE PATIENT WAS PUT ON 81MG ASPIRIN AND 40MG ATORVASTATIN IN RESPONSE TO THIS EVENT. TWO DAYS AFTER PRESENTING TO THE HOSPITAL THE EVEN

  Patient problems: Transient Ischemic Attack

  MAUDE report 15700280 ↗
• InjuryMar 8, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THROMBOSIS AND LEAK OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 33MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. APPROXIMATELY TWO AND A HALF YEARS POST INDEX PROCEDURE, A LARGE THROMBUS WAS SEEN ON THE FACE OF THE CLOSURE DEVICE VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) DURING A ROUTINE TEE APPOINTMENT FOR CARDIOVERSION. A LEAK WAS PREVIOUSLY SEEN DURING THE EARLIER 45-DAY FOLLOW-UP TEE, BUT IS UNKNOWN IF THIS WAS LESS THAN 5MM IN SIZE. HOWEVER, DURING THE FOLLOW-UP APPROXIMATELY TWO AND A HALF YEARS LATER, THE LEAK AROUND THE CLOSURE DEVICE TOWARDS THE MITRAL VALVE GREW LARGER THAN 5MM. THE LEAK WAS OBSERVED TOWARDS THE MITRAL SIDE OF THE LAA. THE PATIENT WAS STARTED BACK ON ORAL ANTICOAGULANTS AND WILL FOLLOW-UP WITH A REPEAT TEE IN 2 MONTHS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13695855 ↗
• InjuryMar 8, 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) 2018 WITH PATIENT IDENTIFIER (B)(6). IT WAS REPORTED THAT CEREBRAL VASCULAR ACCIDENT (CVA) OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. THE PATIENT UNDERWENT SUCCESSFUL PLACEMENT OF A 33MM WATCHMAN LAA CLOSURE DEVICE WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 27.6MM. PRIOR TO INDEX PROCEDURE, ASPIRIN WAS ADMINISTERED. AFTER IMPLANT, THE PATIENT WAS STARTED ON ASPIRIN AND CLOPIDOGREL. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. SEVEN HUNDRED AND SIXTY-SIX DAYS POST-INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH LEFT-SIDED FACIAL DROOP AND DYSARTHRIA. AT THIS TIME THAT PATIENT WAS NOT ON ANY ANTICOAGULANTS. THE PATIENT WAS HOSPITALIZED AND UPON ADMISSION WAS NOTED TO EXPERIENCE SPEECH DISTURBANCE, KNOWLEDGE DEFICIT, AND MOBILITY IMPAIRMENT. TWO DAYS LATER, COMPUTED TOMOGRAPHY WAS PERFORMED AND NEGATIVE FOR INFARCT. MAGNETIC RESONANCE IMAGING (MRI) ANGIOGRAPHY OF THE HEAD WAS PERFORMED REVEALING NORMAL INTRACRANIAL IMAGES. THE SAME DAY MRI OF THE BRAIN WAS PERFORMED REVEALING ONE SLICE PHENOMENA OF SUBTLE RESTRICTED DIFFUSION IN THE RIGHT BASAL GANGLION WHICH MAY OR MAY NOT

  Patient problems: Stroke/CVA

  MAUDE report 13685966 ↗
• InjuryNov 4, 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 33MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED. AT THE FIVE-YEAR FOLLOW UP, A LARGE THROMBUS MEASURING 66 X 37 X 31 MM IN SIZE WAS NOTED TO BE ATTACHED TO THE POSTERIOR AND SUPERIOR ASPECT OF THE LAA WALL AND BRIDGED TO THE WATCHMAN DEVICE. THE DEVICE-RELATED THROMBUS WAS NOTED VIA TRANSTHORACIC ECHOCARDIOGRAM (TTE) AND CONFIRMED WITH MAGNETIC RESONANCE IMAGING (MRI). THE WATCHMAN DEVICE CONTINUED TO OCCLUDE THE LAA. THERE WAS NO THROMBUS NOTED WITHIN THE LAA. IT IS REPORTED THAT THE PATIENT FOLLOWED THEIR POST-IMPLANT DRUG REGIMENT. THE PATIENT WAS PLACED ON WARFARIN AND EXPECTED TO FOLLOW UP TO REASSESS THE THROMBUS IN THREE MONTHS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12751043 ↗
• InjuryApr 29, 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 33MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED FLUSH WITH THE OSTIUM AND NO SHOULDERS WERE NOTED. THE PATIENT WAS DISCHARGED ON XARELTO. AT THE 45-DAY FOLLOW-UP TRANSESOPHAGEAL ECHO (TEE), A 1.0CM THROMBUS WAS NOTED ON THE FACE OF THE DEVICE. IT WAS SUSPECTED THE PATIENT WAS NOT COMPLIANT WITH HIS MEDICATION. THE PATIENT WILL BE SWITCHED TO A DIFFERENT DUAL ORAL ANTICOAGULANT AND WILL BE FOLLOWED UP BY THE CLINIC. THE PATIENT HAS HAD NO ADVERSE PATIENT EFFECTS AS A RESULT OF THIS EVENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11749623 ↗
• InjuryApr 19, 2021Difficult to Open or Close; Material Integrity Problem; Migration; Difficult to Open or Close; Material Integrity Problem; Migration

  IT WAS REPORTED THAT DEVICE IMPLANT MOVEMENT/SHIFT OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 33MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. IN EARLY 2020, THE PATIENT WAS BEING SEEN FOR HEART FAILURE AND A TRANSESOPHAGEAL ECHO (TEE) NOTED THE DEVICE APPEARED TO BE CANTED IN THE OSTIUM OF THE LAA WITH BLOOD FLOW BEHIND THE DEVICE. THE PHYSICIAN BELIEVED THE FABRIC HAD BEEN "ERODED AWAY" ON THE FACE OF THE DEVICE. THE PATIENT IS BEING MANAGED BY THE CARDIOLOGY SERVICE AND THE CURRENT IMPLANTER THERE IS INQUIRING WITH OTHER COLLEAGUES ABOUT PLUGGING THE LEAK. NO ADDITIONAL INFORMATION IS KNOWN AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11690241 ↗
• InjuryMar 2, 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 33MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED WITH A 4MM LEAK REMAINING. THE 45-DAY FOLLOW-UP TRANSESOPHAGEAL ECHO (TEE) SHOWED THE LEAK TO STILL BE 4MM. THE PHYSICIAN INFORMED THE PATIENT A YEAR AFTER IMPLANT THAT THE BEST OPTION WOULD BE TO CLOSE THE LEAK AND THE PATIENT REFUSED TO COME IN. THE PATIENT HAS NOW HAD TWO STROKES AND IS FINALLY INTERESTED IN FIXING THE LEAK. SEVERAL TEE'S WERE TAKEN AFTER THE 45-DAY FOLLOW-UP TEE THAT HAS SHOWED PROGRESSION OF A LARGER LEAK NOW MEASURING ALMOST 6MM WIDE. THE PATIENT IS DOING FINE AND WILL BE GETTING A COMPUTED TOMOGRAPHY (CT) SCAN SOON TO FURTHER EVALUATE THE MEASUREMENT OF THE LEAK. IT WAS FURTHER REPORTED THAT THE PATIENT RECEIVED 8 COILS TO SEAL OFF THE LEAK AND THE PATIENT IS DOING WELL.

  Patient problems: Stroke/CVA

  MAUDE report 11402098 ↗
• InjuryMar 2, 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 33MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED WITH A 4MM LEAK REMAINING. THE 45-DAY FOLLOW-UP TRANSESOPHAGEAL ECHO (TEE) SHOWED THE LEAK TO STILL BE 4MM. THE PHYSICIAN INFORMED THE PATIENT A YEAR AFTER IMPLANT THAT THE BEST OPTION WOULD BE TO CLOSE THE LEAK AND THE PATIENT REFUSED TO COME IN. THE PATIENT HAS NOW HAD TWO STROKES AND IS FINALLY INTERESTED IN FIXING THE LEAK. SEVERAL TEE'S WERE TAKEN AFTER THE 45-DAY FOLLOW-UP TEE THAT HAS SHOWED PROGRESSION OF A LARGER LEAK NOW MEASURING ALMOST 6MM WIDE. THE PATIENT IS DOING FINE AND WILL BE GETTING A COMPUTED TOMOGRAPHY (CT) SCAN SOON TO FURTHER EVALUATE THE MEASUREMENT OF THE LEAK.

  Patient problems: Stroke/CVA

  MAUDE report 11402096 ↗
• MalfunctionMar 2, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT A LEAK OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 33MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED WITH A 4MM LEAK REMAINING. THE 45-DAY FOLLOW-UP TRANSESOPHAGEAL ECHO (TEE) SHOWED THE LEAK TO STILL BE 4MM. THE PHYSICIAN INFORMED THE PATIENT A YEAR AFTER IMPLANT THAT THE BEST OPTION WOULD BE TO CLOSE THE LEAK AND THE PATIENT REFUSED TO COME IN. THE PATIENT HAS NOW HAD TWO STROKES AND IS FINALLY INTERESTED IN FIXING THE LEAK. SEVERAL TEE'S WERE TAKEN AFTER THE 45-DAY FOLLOW-UP TEE THAT HAS SHOWED PROGRESSION OF A LARGER LEAK NOW MEASURING ALMOST 6MM WIDE. THE PATIENT IS DOING FINE AND WILL BE GETTING A COMPUTED TOMOGRAPHY (CT) SCAN SOON TO FURTHER EVALUATE THE MEASUREMENT OF THE LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11402095 ↗
• MalfunctionFeb 19, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT A LEAK OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 33MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. A 1-YEAR COMPUTED TOMOGRAPHY (CT) SCAN FOLLOW-UP WAS PERFORMED AND A 6.6MM LEAK WAS NOTED ON THE MITRAL SIDE. THIS LEAK WAS NOT SEEN ON THE 45-DAY FOLLOW-UP. THE PATIENT WILL BE REASSESSED IN (B)(6) 2021 WITH A PLAN TO CLOSE THE LEAK. THE PATIENT HAS BEEN PLACED BACK ON ORAL ANTICOAGULANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11352119 ↗
• MalfunctionFeb 19, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED A DEVICE LEAK OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 33MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. MULTIPLE DEVICES WERE ATTEMPTED TO CLOSE THE LAA DUE TO A COMPLEX ANATOMY BUT NO ADVERSE EVENTS TOOK PLACE. AT THE 3-MONTH TRANSESOPHAGEAL ECHO (TEE) FOLLOW-UP, A VISIBLE LOBE WAS UNCOVERED THAT MEASURED 10-11MM. ON (B)(6) 2021, THE PATIENT WAS BROUGHT BACK TO OCCLUDE THE EXPOSED INFERIOR LOBE NEXT TO THE IMPLANTED 33MM DEVICE. A 20MM NON-BOSTON SCIENTIFIC PLUG WAS ATTEMPTED FIRST UNDER ECHO AND FLUOROSCOPY GUIDANCE BUT IT WAS TOO LARGE. THEY THEN USED AN 18MM NON-BOSTON SCIENTIFIC PLUG WHICH SUCCESSFULLY OCCLUDED THE EXPOSED LOBE AND WAS DEPLOYED. AN EFFUSION STARTED TO DEVELOP POST-DEPLOYMENT BUT THERE WERE NO SIGNS OF CARDIAC TAMPONADE. THE EFFUSION MEASURED 1.8CM-2.0CM SO A PERICARDIOCENTESIS WAS PERFORMED TO TREAT THE EFFUSION. APPROXIMATELY 500-600ML OF BLOOD WAS REMOVED AND A DRAIN WAS PLACED. THE EFFUSION WAS NO LONGER VISIBLE ON TEE AND TRANSTHORACIC ECHO (TTE). THE PATIENT STAYED OVERNIGHT AND THE DRAIN WAS REMOVED THE FOLLOWING MORNING. NO OTHER ADVERSE EVENTS TOOK PLACE AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11350767 ↗
• InjuryFeb 17, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERFORATION, PERICARDIAL EFFUSION AND CARDIAC TAMPONADE OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. NO BASELINE EFFUSION WAS DETECTED PRIOR TO THE PROCEDURE. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE SEPTUM WAS CROSSED USING STANDARD PROCEDURE AND NO EFFUSION WAS NOTED POST CROSSING. THE FIRST DEVICE WAS DEPLOYED TOO PROXIMAL AND RECAPTURED. AN EFFUSION CHECK WAS CLEAR. A SECOND DEVICE WAS DEPLOYED BUT FAILED THE TUG TEST AND WAS FULLY RECAPTURED. AN EFFUSION CHECK WAS CLEAR. A THIRD 33MM DEVICE WAS DEPLOYED AND AN IMMEDIATE EFFUSION WAS NOTED BY THE ECHO PHYSICIAN. A PERFORATION OF THE DISTAL LAA OCCURRED LEADING TO CARDIAC TAMPONADE. A CLINICALLY SIGNIFICANT BLOOD PRESSURE DROP WAS NOTED WHEN THE EFFUSION DEVELOPED AND INCREASED IN SIZE. A PERICARDIOCENTESIS WAS PERFORMED AND THE EFFUSION WAS MINIMIZED. THE PHYSICIAN RECHECKED THE DEVICE AND ATTEMPTED A TUG TEST BUT IT FAILED AND THE DEVICE WAS REMOVED. THE EFFUSION INCREASED ONCE THE DEVICE WAS REMOVED. PERICARDIOCENTESIS CONTINUED AND WHEN THE PATIENT WAS STABILIZED, SHE WAS TRANSFERRED TO AN OP

  Patient problems: Cardiac Tamponade; Perforation; Pericardial Effusion

  MAUDE report 11337507 ↗
• InjuryJan 8, 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 TRACE EFFUSION WAS NOTED AT THE BEGINNING OF THE CASE. HEPARIN WAS GIVEN. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 33MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE DEVICE WAS PARTIALLY RECAPTURED A FEW TIMES. AFTER RELEASE OF THE DEVICE, A SWEEP WAS PERFORMED FOR A POST-EFFUSION CHECK AND THE EFFUSION HAD INCREASED FROM BASELINE. THERE WERE NO BLOOD PRESSURE DROPS AND THE PATIENT WAS STABLE THE ENTIRE CASE. THE PATIENT WAS GIVEN PROTAMINE AND NO SIGNIFICANT EVENTS OCCURRED. THE OUTCOME WAS STILL A SUCCESSFUL IMPLANT. THE PATIENT WAS DISCHARGED.

  Patient problems: Pericardial Effusion

  MAUDE report 11141990 ↗
• InjuryDec 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION AND PERFORATION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 33MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. THE CLOSURE DEVICE WAS DEPLOYED IN THE LAA OF THE PATIENT. WHILE IN RECOVERY, THE PATIENT EXPERIENCED PAIN WITH THEIR BREATHING AND THE PHYSICIAN ORDERED A SONOGRAM. A PERICARDIAL EFFUSION WAS NOTED. IT WAS SUSPECTED THAT DURING THE PROCEDURE, THE DEVICE ANCHOR LEGS PERFORATED THE SIDE OF THE LAA AND CAUSED AN EFFUSION, ALTHOUGH IT WAS NOT NOTICED UNTIL AFTER THE PROCEDURE. A PERICARDIOCENTESIS WAS PERFORMED AND 800CC OF FLUID WAS REMOVED. THE PATIENT WAS HOSPITALIZED FOR THREE DAYS.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 10969978 ↗
• InjuryDec 3, 2020Adverse 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 PERFORMED AND A 33MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. POST-PROCEDURE, THE PATIENT EXPRESSED DISCOMFORT AND THERE WAS A CHANGE IN BLOOD PRESSURE. A TRANSTHORACIC ECHO WAS PERFORMED AND A PERICARDIAL EFFUSION WAS NOTED. A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS REPORTED TO BE STABLE AND WAS DISCHARGED.

  Patient problems: Pericardial Effusion

  MAUDE report 10938723 ↗
• MalfunctionDec 2, 2020Difficult to Open or Close; Difficult to Open or Close

  (B)(6) STUDY. IT WAS REPORTED THAT DEVICE LEAK OCCURRED. THE PATIENT WAS ON REGULAR ASPIRIN AND CLOPIDOGREL REGIMEN PRIOR TO CONSENT AND SCREENING FOR THE STUDY. PRIOR TO THE PROCEDURE, ASPIRIN WAS ADMINISTERED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 33MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED WITH COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 27.3MM. AFTER THE IMPLANT THE PATIENT WAS STARTED ON CLOPIDOGREL. THE PATIENT WAS DISCHARGED ON (B)(6) 2019. ON (B)(6) 2020, THE THREE-MONTH FOLLOW-UP CORE LAB TRANSESOPHAGEAL ECHO (TEE) EVALUATION REVEALED AN INCOMPLETE LAA SEAL WITH A JET SIZE GREATER THAN 5MM. HOWEVER, THE SIZE OF LARGEST RESIDUAL JET AROUND DEVICE WAS REPORTED AS 2MM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10934663 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PERICARDIAL EFFUSION AND TAMPONADE OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 33MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE 33MM DEVICE WAS SUCCESSFULLY INSERTED INTO THE LAA AFTER ONE PARTIAL RECAPTURE WAS PERFORMED. AFTER THE PROCEDURE THERE WAS NO EFFUSION PRESENT AND PROTAMINE WAS NOT GIVEN AFTER THE CASE. TWO HOURS POST-PROCEDURE, THE PATIENT BEGAN TO EXPERIENCE TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED, A PERICARDIAL DRAIN WAS PLACED AND THE PATIENT WAS STABILIZED. THE PATIENT FULLY RECOVERED AND WAS DISCHARGED. THE PATIENT RETURNED TO THE CLINIC ON (B)(6) 2020 FOR A FOLLOW-UP VISIT AND WAS REPORTED TO BE STABLE.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 10927474 ↗

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,