WATCHMAN® M635WU30060Recalls & reported problems

Summary

The FDA's MAUDE database contains 295 adverse event reports that list this exact device (DI 08714729838258), received between Nov 15, 2016 and Feb 24, 2026 — classified as 8 deaths, 243 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (34 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 295 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2026Failure to Seal

  IT WAS REPORTED THAT STROKE OCCURRED. A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE WAS PERFORMED, AND A 30MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED ON 17-DEC-2020. APPROXIMATELY 6 YEARS LATER, THE PATIENT PRESENTED TO THE HOSPITAL AFTER HAVING A STROKE. THE PHYSICIAN SUSPECTED THERE MAY BE A PERI-DEVICE LEAK AND IS CONSIDERING USING A PLUG OR COIL TO TREAT THE LEAK, BUT THIS HAS NOT YET BEEN CONFIRMED. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED AND WAS NEGATIVE FOR CLOT. THE PATIENT WAS RESTARTED ON THEIR BLOOD THINNERS.

  Patient problems: Stroke/CVA

  MAUDE report 24430549 ↗
• InjuryApr 25, 2025Difficult to Open or Close; Difficult to Open or Close

  REPORTED VIA PATIENT CALL CENTER. IT WAS REPORTED THAT THE DEVICE DID NOT SEAL. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) AND A 30 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. THE PATIENT CAME IN FOR THEIR 45 DAY FOLLOW UP IMAGING PROCEDURE. THE IMAGING SHOWED THAT THERE WAS A 5 MM LEAK PRESENT. THE PATIENT REMAINED ON THEIR ELIQUIS MEDICATION IN RESPONSE TO THIS EVENT. FIVE (5) YEARS POST PROCEDURE THE PATIENT UNDERWENT A PROCEDURE TO PLUG THE LEAK. THE PROCEDURE WAS UNSUCCESSFUL AS THE COILS COULD NOT BE PLACED. THE PATIENT REMAINS ON THEIR ELIQUIS MEDICATION. THERE WERE NO OTHER COMPLICATIONS THAT WERE REPORTED TO HAVE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909870 ↗
• InjuryFeb 26, 2025Difficult to Open or Close; Difficult to Open or Close

  REPORTED VIA WATCHMAN PATIENT CALL CENTER. IT WAS REPORTED THAT THE DEVICE DID NOT SEAL, AND A TRANSIENT ISCHEMIC ATTACK (TIA) OCCURRED. A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE WAS PERFORMED ON (B)(6) 2019, AND A 30MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. IT WAS REPORTED TO BOSTON SCIENTIFIC (BSC) ON (B)(6) 2025, THAT THE PATIENT HAD EXPERIENCED A TIA FIVE TO SIX MONTHS AGO. WHILE BEING TREATED FOR THE TIA, IMAGING REVEALED THE CLOSURE DEVICE WAS NOT SEALING THE LAA AND IN RESPONSE, THE PHYSICIANS PLACED THE PATIENT BACK ON A MEDICATION REGIMEN. NO FURTHER DETAILS WERE MADE AVAILABLE.

  Patient problems: Transient Ischemic Attack

  MAUDE report 21470743 ↗
• InjuryApr 23, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT PERI-DEVICE LEAK OCCURRED. A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE WAS PERFORMED AND A 30MM WATCHMAN CLOSURE DEVICE WAS IMPLANTED IN (B)(6) 2020. AT A ROUTINE FOLLOW UP APPOINTMENT IN (B)(6) 2024, COMPUTED TOMOGRAPHY (CT) WAS PERFORMED WHICH REVEALED A PERI-DEVICE LEAK MEASURING 8.2MM. THE PERI-DEVICE LEAK WAS CLOSED WITH PLACEMENT OF A NON-BOSTON SCIENTIFIC DUCT OCCLUDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19165798 ↗
• InjuryNov 15, 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 VIA SOCIAL MEDIA THAT A PATIENT EXPERIENCED A CEREBRAL VASCULAR ACCIDENT. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 30MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED ON (B)(6) 2018. IT WAS REPORTED THAT IN (B)(6) 2022, THE PATIENT HAD DISCONTINUED ANTICOAGULATION MEDICATION AND EXPERIENCED A CEREBRAL VASCULAR ACCIDENT. THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS ADMITTED TO THE HOSPITAL FOR FURTHER ASSESSMENT AT THAT TIME. THE PATIENT HAS SINCE BEEN DISCHARGED AND CONTINUES TO FOLLOW UP WITH THEIR PRIMARY NEUROSURGEON EVERY SIX MONTHS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Stroke/CVA

  MAUDE report 18144743 ↗
• InjuryMar 31, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THROMBOSIS AND IMPLANT FABRIC DAMAGE OCCURRED. A LEFT ATRIAL APPENDAGE CLOSURE (LAA) PROCEDURE WAS PERFORMED AND A 30MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. DURING A FOLLOW-UP TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) ON (B)(6)2020, A LARGE DEVICE RELATED THROMBUS (DRT) WAS NOTED. ON SUBSEQUENT TEES PERFORMED ON (B)(6)2020 AND (B)(6) (B)(6) 2020, THE DRT WAS NOTED TO BE SMALLER. THE PATIENT HAD ANOTHER TEE PERFORMED ON (B)(6) 2023 AND IT WAS THOUGHT THERE WAS A HOLE IN THE DEVICE. THERE APPEARED TO BE A FLAP OF FABRIC THAT WAS NO LONGER SUTURED TO THE STRUTS AND WAS FLAPPING WITH EACH HEARTBEAT. THERE APPEARED TO BE A JET COMING FROM THIS AREA AS WELL. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE PATIENT DOES NOT TOLERATE BLOOD THINNERS WELL DUE TO THE INTERACTION WITH ARTHRITIS MEDICATION. THE PHYSICIAN IS POTENTIALLY CONSIDERING REMOVAL OF THE DEVICE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16656062 ↗
• InjuryMar 30, 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) WAS POSITIONED AND A WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE PROCEDURE WENT AS PLANNED AND THE CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED IN THE LAA OF THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS THAT WERE REPORTED TO HAVE OCCURRED. 6 WEEKS POST PROCEDURE THE PATIENT HAD A FOLLOW UP PROCEDURE. THERE WERE NO DEVICE LEAKS OR A DEVICE RELATED THROMBUS. THE PATIENT WAS TAKEN OFF OF THEIR ANTICOAGULATION MEDICATION. 8 WEEKS POST PROCEDURE THE PATIENT PRESENTED TO THE HOSPITAL WITH A CEREBRAL VASCULAR ACCIDENT. IMAGING TESTS SHOWED THAT THERE WAS NO DEVICE RELATED THROMBUS OR ANY DEVICE LEAKS. A THROMBUS WAS NOTED BEHIND THE CLOSURE DEVICE. 5 MONTHS POST PROCEDURE THE PATIENT HAD A TRANSESOPHAGEAL ECHOCARDIOGRAM PROCEDURE. THE IMAGING SHOWED NO DEVICE RELATED THROMBUS OR LEAKS. THE IMAGING STILL SHOWED THE THROMBUS BEHIND THE CLOSURE DEVICE. 7 MONTHS POST PROCEDURE THE PATIENT PRESENTED WITH A SYNCOPAL EPISODE. NO DEVICE RELATED THROMBUS OR LEAK WAS NOTED. THE AREA AFFECTED BY THE

  Patient problems: Stroke/CVA

  MAUDE report 13957464 ↗
• InjuryJul 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A THROMBOSIS AND CEREBRAL VASCULAR ACCIDENT (CVA) OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 30MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. AT THE 45 DAY FOLLOW UP APPOINTMENT ON (B)(6) 2020, THE TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) NOTED THAT THE CLOSURE DEVICE STILL MET IMPLANT CRITERIA. THE PATIENT WAS THEN TAKEN OFF ELIQUIS AND PLACED ON PLAVIX AND ASPIRIN ON (B)(6) 2020. THE PATIENT PRESENTED TO THE HOSPITAL FOR NOSE BLEED ON (B)(6) 2021 AND (B)(6) 2021. PLAVIX WAS THEN DISCONTINUED ON (B)(6) 2021 AND THE ASPIRIN DOSE WAS INCREASED TO 325MG. ON (B)(6) 2021, THE PATIENT PRESENTED TO THE HOSPITAL WITH A LEFT TEMPORAL CVA. TEE ALSO FOUND THROMBUS ON THE CLOSURE DEVICE. THERE WAS NO INTERVENTION PERFORMED FOR THE STROKE NOR FOR RETRIEVAL OF THE CLOT AS THE PATIENT WAS NOT A CANDIDATE FOR TISSUE PLASMINOGEN ACTIVATOR TREATMENT. FOLLOW UP WAS AGAIN PERFORMED ON 19MAY2021 AND THE PATIENT WAS OVERALL DOING WELL WITH SOME RESIDUAL SPEECH DIFFICULTY. THE PATIENT RETURNED BACK AT THE NURSING HOME THEY WERE PREVIOUSLY RESIDING FROM.

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 12122011 ↗
• InjuryMay 28, 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 4 WATCHMAN LAA CLOSURE DEVICES WERE ATTEMPTED. DURING THE PROCEDURE, 4 DIFFERENT CLOSURE DEVICES WERE ATTEMPTED AS THE PATIENT HAD A DIFFICULT LAA TO SUPPORT THE WATCHMAN IMPLANT, SO NO DEVICE WAS IMPLANTED. THE INTERNATIONAL NORMALIZED RATIO (INR) WAS 1.5 DURING THE PROCEDURE. THE PATIENT WOKE UP 3 HOURS POST PROCEDURE AND HAD A STROKE IN WHICH THEY WERE HOSPITALIZED FOR A WEEK. THE PHYSICIAN STATED THE PATIENT COULD ATTEMPT A WATCHMAN FLX CLOSURE DEVICE ON A LATER DATE, BUT THE PATIENT DECLINED THIS SUGGESTION. THE PATIENT RECOVERED AND WAS DOING WELL AFTER THIS EVENT.

  Patient problems: Stroke/CVA

  MAUDE report 11901426 ↗
• InjuryMay 13, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DEVICE EMBOLIZATION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 30MM WATCHMAN LAA CLOSURE DEVICE WAS SUCCESSFULLY DEPLOYED IN THE LEFT ATRIAL APPENDAGE. ONE PARTIAL RECAPTURE WAS PERFORMED PRIOR TO IMPLANTATION OF THE CLOSURE DEVICE. AFTER RELEASE, THERE WAS A SHIFT IN THE DEVICE. AT THE PATIENT'S 45 DAY FOLLOW UP APPOINTMENT ON (B)(6) 2021, THE CLOSURE DEVICE COULD NOT BE SEEN VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). ON (B)(6) 2021, THE DEVICE STILL COULD NOT BE SEEN VIA COMPUTED TOMOGRAPHY (CT) OF THE PATIENT'S CHEST. THE PATIENT DID NOT EXHIBIT SYMPTOMS, HOWEVER, SHOWED A DECREASE IN RENAL FUNCTION. ON (B)(6) 2021, THE PATIENT REPORTED TO THE ELECTROPHYSIOLOGY (EP) SUITE WHERE FLUOROSCOPY SHOWED THE CLOSURE DEVICE IN THE AREA OF THE RENAL ARTERIES LOGGED IN THE AORTA. AN ATTEMPT WAS MADE TO SNARE THE CLOSURE DEVICE, HOWEVER, THIS WAS UNSUCCESSFUL AFTER A COUPLE OF HOURS USING VARIOUS SNARES AND BIOTOME DEVICES. THE DEVICE HAD BEEN MOVED BACK TO THE ILIAC ARTERY. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM WHERE A FEMORA CUT DOWN WAS PERFORMED. THE CLOSURE DEVICE WAS THEN SUCCESSFULLY EXPLANTED FROM THE PATIENT. THE PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11816086 ↗
• InjuryMay 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 30MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. INITIALLY A 27MM DEVICE WAS DEPLOYED BUT WAS RECAPTURED AND REMOVED. A 30MM DEVICE WAS THEN USED AND WAS ALSO RECAPTURED AND REDEPLOYED AND IMPLANTED. A FEW HOURS POST-IMPLANT, A PERICARDIAL EFFUSION WAS NOTED AND A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT RECOVERED IN THE INTENSIVE CARE UNIT AND REQUIRED A BLOOD TRANSFUSION. THE PATIENT WAS STABLE AND WAS DISCHARGED.

  Patient problems: Pericardial Effusion

  MAUDE report 11783914 ↗
• MalfunctionApr 29, 2021Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED A KINK AND RECAPTURE DIFFICULTY OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM AND TWO WATCHMAN LAA CLOSURE DEVICE AND DELIVERY SYSTEMS WERE USED. A PERICARDIAL EFFUSION WAS NOTED AT BASELINE AROUND THE RIGHT ATRIUM (RA) AND RIGHT VENTRICLE (RV). IT WAS NOTED THAT THE BASELINE EFFUSION AROUND THE RA HAD GROWN SLIGHTLY AFTER A VERY DIFFICULT TRANSEPTAL PUNCTURE, BUT THE PATIENT WAS STABLE. A 33MM WATCHMAN LAA CLOSURE DEVICE WAS DEPLOYED, BUT WAS PROXIMAL. THEREFORE, A FULL RECAPTURE WAS PERFORMED AND EFFUSION WAS NOTED TO BE STABLE. A 30MMWATCHMAN LAA CLOSURE DEVICE WAS ATTEMPTED NEXT. THE DEVICE LANDED SLIGHTLY DEEP AND A PARTIAL RECAPTURE WAS PERFORMED. IT WAS NOTED THAT THE DEVICE WAS HOOKED ON THE APPENDAGE WALL. DURING A RECAPTURE ATTEMPT THE ACCESS SYSTEM KINKED AT THE DARK-LIGHT BLUE TRANSITION AND THERE WAS A STRUGGLE TO PULL THE FEET OF THE DEVICE INTO THE ACCESS SYSTEM DUE TO THE LARGE KINK. A KINK WAS ALSO NOTED IN THE DELIVERY SYSTEM. PROACTIVELY, A PERICARDIAL DRAIN WAS PUT IN AND 100CCS WAS DRAINED. THE 30MM DEVICE WAS SUCCESSFULLY RECAPTURED AND THE EFFUSION WAS NOTED TO BE STABLE. ANOTHER ACCESS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11749429 ↗
• InjuryApr 26, 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 30MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED WITH NO LEAK NOTED. AN ANTERIOR GUTTER WAS PRESENT AT IMPLANT. ANTI-COAGULATION WAS STOPPED AT 45-DAY POST-IMPLANT. AT THE ROUTINE 4-MONTH TRANSESOPHAGEAL ECHO (TEE), A DEVICE RELATED THROMBUS ON THE DEVICE WAS NOTED ON THE SIDE OF THE CENTER PIN ON THE FACE OF THE DEVICE LEANING TOWARDS THE ANTERIOR SIDE, BUT NOT FILLING THE GUTTER. THE PATIENT CURRENTLY HAS NO SYMPTOMS. THE PATIENT WILL RESTART XARELTO AND A REPEAT TEE WILL BE PERFORMED IN APPROXIMATELY 3 MONTHS TO SEE IF THE THROMBUS HAS RESOLVED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11727216 ↗
• InjuryApr 5, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT A CEREBRAL VASCULAR ACCIDENT (CVA) OCCURRED. ON (B)(6) 2020, A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 30MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED WITH NO RESIDUAL LEAK. A TRANSESOPHAGEAL ECHO (TEE) SCHEDULED FOR (B)(6) 2020 WAS CANCELLED DUE TO COVID. THE PATIENT WAS ADVISED TO STOP COUMADIN AND START DUAL ANTIPLATELET THERAPY (DAPT). ON (B)(6) 2020, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A CVA. COUMADIN WAS RESTARTED AT THIS TIME. NO INTERVENTION WAS DONE AS THE PATIENT PRESENTED TO EMERGENCY ROOM GREATER THAN 5 HOURS AFTER THE ONSET OF SYMPTOMS. A CORONARY COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) ON (B)(6) 2020 REVEALED A LEAK ALONG THE LATERAL INFERIOR ASPECT OF THE WATCHMAN DEVICE AND THROMBUS EXTERNAL TO THE WATCHMAN ANTERIOR SUPERIOR ASPECT. A CTA PERFORMED ON (B)(6) 2020 SHOWED NO DEVICE RELATED THROMBUS. THE PATIENT WAS CALLED AND ADVISED TO STOP COUMADIN AND RESTART DAPT. A TEE PERFORMED ON (B)(6) 2020 SHOWED NO DEVICE RELATED THROMBUS, BUT A 5-6MM GAP AROUND THE DEVICE WAS NOTED. ON (B)(6) 2020 THE PATIENT WAS CALLED AND ADVISED TO STOP COUMADIN. THE PATIENT WAS VERY HESITANT TO DO THIS. DURING THE 1-YEAR FOLLOW-UP C

  Patient problems: Stroke/CVA

  MAUDE report 11617023 ↗
• InjuryFeb 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. A 30MM WATCHMAN LAA CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS ON XARELTO. THE FOLLOWING MORNING AT 8 A.M., A SMALL PERICARDIAL EFFUSION WAS NOTICED. THERE WERE NO SIGNS OF TAMPONADE. THE PATIENT'S BLOOD PRESSURE CHANGED AND WAS TREATED WITH MIDODRINE. ECHOCARDIOGRAMS WERE PERFORMED DAILY AND A TRANSTHORACIC ECHOCARDIOGRAM SHOWED A POSSIBLE MILD INCREASE IN THE SIZE OF THE EFFUSION ON THE SUBCOSTAL VIEWS. THE PATIENT WAS DISCHARGED HOME FOUR DAYS POST PROCEDURE AND WILL BE FOLLOWED AS OUTPATIENT.

  Patient problems: Pericardial Effusion

  MAUDE report 11362602 ↗
• InjuryFeb 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION WITH TAMPONADE OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS ATTEMPTED. NO PERICARDIAL EFFUSION WAS NOTED PRIOR TO THE PROCEDURE. MULTIPLE WATCHMAN LAA CLOSURE DEVICE AND DELIVERY SYSTEMS WERE USED. MULTIPLE CLOSURE DEVICES WERE DEPLOYED, BUT NO CLOSURE DEVICE WAS IMPLANTED DUE TO ANATOMICAL CHALLENGES AND SUBOPTIMAL RESULTS. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS DISCHARGED HOME SEVEN HOURS POST PROCEDURE. WITHIN ONE HOUR, THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT WITH A SYNCOPAL EPISODE AND RIGHT VENTRICLE COLLAPSE. AN ECHOCARDIOGRAM SHOWED A NEW MODERATELY SIZED PERICARDIAL EFFUSION WITH EARLY SIGNS OF CARDIAC TAMPONADE. THE PATIENT WAS TAKEN PROMPTLY TO THE CATHETERIZATION LAB AND UNDERWENT SUCCESSFUL PERICARDIOCENTESIS WITH DRAIN PLACEMENT. 410 CC OF SANGUINEOUS FLUID WAS REMOVED. THE PATIENT HAS PLEURITIC CHEST PAIN, BUT HIS BREATHING HAS IMPROVED. THE PATIENT REMAINED HOSPITALIZED, BUT HIS DRAIN WAS REMOVED.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 11360933 ↗
• InjuryFeb 12, 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 BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 30MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE DEVICE MET RELEASE CRITERIA AND WAS RELEASED. APPROXIMATELY 30 SECONDS AFTER RELEASE, IT WAS NOTED ON ECHO THAT THERE WAS SOME UNKNOWN OBJECT SWINGING ON THE FACE OF THE DEVICE. THIS WAS SEEN IN NUMEROUS ECHO VIEWS. THE PATIENT WAS TAKEN OFF THE TABLE WITHOUT ANY NOTABLE ISSUES OR INTERVENTIONS. LATER THAT EVENING, THE PATIENT EXPERIENCED APHASIA. A MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED WHICH CONFIRMED THE PATIENT HAD A STROKE. THE PATIENT REMAINS IN THE HOSPITAL.

  Patient problems: Stroke/CVA

  MAUDE report 11324184 ↗
• InjuryFeb 3, 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. AN ANTERIOR WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 30MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE DEVICE WAS DEPLOYED AND NO RECAPTURES OR REPOSITIONING WAS NEEDED. A FEW HOURS AFTER THE PROCEDURE, THE PATIENT HAD A PERICARDIAL EFFUSION. THEY PLACED A DRAIN AND THE PATIENT WAS SENT BACK TO THE FLOOR. LATER ON THAT NIGHT THE PATIENT HAD MORE SYMPTOMS SO THEY DECIDED TO DO SURGERY TO EXPLANT THE WATCHMAN DEVICE AND CLIP THE APPENDAGE. THE PATIENT WAS DISCHARGED.

  Patient problems: Pericardial Effusion

  MAUDE report 11274718 ↗
• InjuryFeb 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBOSIS AND A CEREBRAL VASCULAR ACCIDENT OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 30MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. THE FOLLOWING WEEKEND, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH STROKE-LIKE SYMPTOMS. A TRANSESOPHAGEAL ECHO (TEE) SHOWED A LARGE THROMBUS ON THE DEVICE. SURGICAL INTERVENTION AS PERFORMED TO REMOVE THE CLOT AND THE WATCHMAN DEVICE WAS SUBSEQUENTLY EXPLANTED AND THE LAA WAS LIGATED.

  Patient problems: Stroke/CVA; Thrombosis/Thrombus; Transient Ischemic Attack

  MAUDE report 11270102 ↗
• InjuryDec 18, 2020Adverse 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 30MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. THE PATIENT WAS ON ELIQUIS UP UNTIL 45 DAYS POST IMPLANT, THEN ASPIRIN 81MG AND PLAVIX UNTIL 6 MONTHS AND THEN ONLY ASPIRIN 81MG AFTER THAT. THE 45-DAY FOLLOW-UP TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) PERFORMED ON (B)(6) 2020 WAS WITHIN NORMAL LIMITS. THE 1-YEAR FOLLOW-UP COMPUTERIZED TOMOGRAPHY (CT) SCAN PERFORMED ON (B)(6) 2020 IDENTIFIED A LAMINAR, NON-MOBILE, DEVICE RELATED THROMBUS BETWEEN THE THREADED INSERT ON THE FACE OF DEVICE AND THE LIMBUS. THE THROMBUS WAS MILDLY BIASED TOWARD THE LIMBUS. ANTICOAGULATION THERAPY IS EXPECTED TO RESUME AND A FOLLOW-UP TEE WILL BE PERFORMED IN A FEW MONTHS. THE PATIENT IS CURRENTLY ASYMPTOMATIC.

  Patient problems: Thrombosis

  MAUDE report 11038423 ↗
• InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERFORATION AND A PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A TRACE BASELINE EFFUSION WAS PRESENT PRIOR TO THE PROCEDURE. AFTER INTUBATION OF THE PATIENT, COMPLETE BASELINE ECHO IMAGES WERE OBTAINED. ACCESS WAS THEN OBTAINED AND A TRANSSEPTAL CROSSING WAS COMPLETED. THE SL1 SHEATH WAS THEN EXCHANGED FOR THE ANTERIOR CURVE WATCHMAN ACCESS SYSTEM (WAS) SHEATH, THE PATIENT WAS ANTICOAGULATED AND A PIGTAIL INJECTION WAS COMPLETED. UPON INJECTION, THE OSTIUM WAS MARKED, AND A 30MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) SHEATH WAS ADVANCED AND DEPLOYED USING THE UNSHEATHING TECHNIQUE. IT WAS NOTED THAT THE DEVICE DID ADVANCE FORWARD AT THE BEGINNING OF THE DEPLOYMENT SEQUENCE; HOWEVER, NO CHANGES IN THE PERICARDIUM WERE SEEN AT THE END OF THE CASE. THE DEVICE WAS RELEASED AFTER MEETING RELEASE CRITERIA AND THE PROCEDURE WAS FINISHED. A FILLING DEFECT WAS NOTED IN THE APEX OF THE APPENDAGE WITH CONTRAST INJECTION, BELIEVED TO BE AN AIR BUBBLE. THE PATIENT WAS THEN EXTUBATED, AND TRANSFERRED TO THE RECOVERY ROOM WHERE SHE HEMODYNAMICALLY DECOMPENSATED ABOUT 90 MINUTES LATER. THE PHYSICIAN COMPLETE

  Patient problems: Cardiac Perforation; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 11007299 ↗
• 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 BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 30MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. AFTER GAINING DEPTH IN THE LAA AND REMOVING THE PIGTAIL CATHETER FROM THE WAS THE DEVICE WAS LOADED INTO THE WAS. ONCE THE DEVICE WAS ABOUT 75% IN THE SHEATH IT WAS NOTED THAT THE SHEATH HAD MOVE FORWARD AND APPEARED TO BE OUTSIDE OF THE LAA. THEY SWEPT FOR AN EFFUSION USING TRANSESOPHAGEAL ECHO (TEE) AND NO EFFUSION WAS APPRECIATED. CONTRAST WAS THEN USED AND IT WAS NOTED THAT SOME CONTRAST WAS FLOWING OUTSIDE THE APPENDAGE. THE DEVICE WAS QUICKLY DEPLOYED AND RELEASE CRITERIA WAS ASSESSED AND MET. THE DEVICE WAS RELEASED. THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP AND AN EFFUSION WAS NOTICED TO BE ABOUT 1CM ON TEE. A PERICARDIOCENTESIS WAS PERFORMED AND 350ML WAS DRAWN FROM THE SPACE. IT WAS IMMEDIATELY DELIVERED BACK THROUGH THE WAS. HEPARIN WAS REVERSED AND THE EFFUSION MINIMIZED. THE PATIENT'S BLOOD PRESSURE REMAINED LOW AFTER GIVING 3L OF FLUID. TWO UNITS OF BLOOD WERE GIVEN. THE PATIENT'S BLOOD PRESSURE STABILIZED AND THE PATIENT WAS EX

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 10942903 ↗
• MalfunctionDec 1, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THE DEVICE WAS DIFFICULT TO RECAPTURE. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 30MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE 30MM DEVICE WAS DEPLOYED. SEVERAL ATTEMPTS WERE PERFORMED TO RECAPTURE THE DEVICE BUT BY APPEARANCE THE FEET OF THE DEVICE WERE TANGLED IN TISSUE AND COULD NOT BE SAFELY RELEASED. THE DEVICE WAS RELEASED WITH A 4MM LEAK AND UNCOVERED LOBE DUE TO NOT BEING ABLE TO MOVE THE DEVICE PROXIMALLY. THERE WAS NO ADVERSE EVENT TO THE PATIENT OR DURING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10929942 ↗
• InjuryNov 25, 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 30MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. THE PATIENT WAS DISCHARGED. THE PATIENT WAS READMITTED (B)(6) 2020 THROUGH (B)(6) 2020 AND THEN AGAIN ON (B)(6) 2020 THROUGH (B)(6) 2020. DURING THE FIRST READMISSION THE PATIENT PRESENTED WITH WEAKNESS, EDEMA, AND WORSENING URINE OUTPUT (PATIENT ON HOME DIALYSIS). A SMALL PERICARDIAL EFFUSION WAS SEEN ON THE ECHOCARDIOGRAM. THE PATIENT WAS WORKED UP FOR TAMPONADE. AN ECHO WAS PERFORMED WHICH SHOWED NO TAMPONADE. A TEE WAS PERFORMED AND NO CLOT WAS PRESENT. ON (B)(6) 2020, THE PATIENT WAS ATTEMPTED TO BE CARDIOVERTED BUT THIS WAS UNSUCCESSFUL. REPEAT CARDIOVERSION ATTEMPT ON (B)(6) 2020 WAS ALSO UNSUCCESSFUL. THE PATIENT WAS DISCHARGED HOME WITH PLANS TO BE SEEN AS AN OUTPATIENT. DURING THE (B)(6) 2020 HOSPITALIZATION THE PATIENT HAD A REPEAT ECHO AND SHOWED AN INCREASE IN THE PERICARDIAL EFFUSION FROM PREVIOUS STUDIES. ON (B)(6) 2020, THE PATIENT HAD A PERICARDIOCENTESIS WITH REMOVAL OF 1200CC OF FLUID WITH A DRAIN LEFT IN PLACE. THE PATIENT ALSO HAD AN ABLATION AND PACEMAKER PLACED. THE IMPLANTED DEVICE LOOKED OK

  Patient problems: Pericardial Effusion

  MAUDE report 10905648 ↗
• InjuryNov 18, 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 30MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. AFTER DEVICE DEPLOYMENT, THE PATIENT'S BLOOD PRESSURE DROPPED TO 80/60, AND PERICARDIAL EFFUSION AND TAMPONADE WERE NOTED. A PERICARDIOCENTESIS WAS PERFORMED AND 1500CC OF BLOOD WAS DRAINED INITIALLY. THE BLEEDING DID NOT RESOLVE AND THE CLOSURE DEVICE WAS NOT IN A POSITION THAT WAS ADEQUATE TO SEAL THE OSTIUM. UPON TRANSFER TO THE OPERATING ROOM THE PATIENT'S BLOOD PRESSURE INCREASED TO 130/70. THE CLOSURE DEVICE WAS STILL ATTACHED TO THE CORE WIRE AND IN THE PATIENT. THE DEVICE WAS REMOVED FROM THE PATIENT DURING SURGERY. THE PATIENT IS RECOVERING IN THE INTENSIVE CARE UNIT.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 10860788 ↗

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