WATCHMAN FLX™ Pro M635WU60400Recalls & reported problems

Summary

The FDA's MAUDE database contains 104 adverse event reports that list this exact device (DI 00191506004637), received between Nov 17, 2023 and Sep 17, 2026 — classified as 10 deaths, 91 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Seal” (27 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 104 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Material Deformation; Migration; Failure to Seal

  It was reported that device migration occurred and the implant did not seal. A left atrial appendage closure (LAAC) procedure was performed and a 40mm WATCHMAN FLX Pro LAA Closure Device and Delivery System (WDS) was implanted on (b)(6)2025. At the routine 45 day follow up, no concerns were reported. However, imaging at the one year follow up showed the device was tucked on the mitral side and there was a leak on the right side. The device was slightly distal and no longer met the position portion of the position, anchor, size and seal (PASS) criteria. There was no additional information provided.It was further reported that there was no peri-device leak, but rather an intra-fabric flow.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50803596 ↗
• InjurySep 17, 2026Migration; Failure to Seal

  It was reported movement/shift and implant did not seal occurred.A left atrial appendage (LAA) closure procedure was performed, and a 40mm WATCHMAN FLX Pro Closure Device was successfully implanted. The patient was discharged. At a subsequent routine follow up, it was noted the Closure Device had shifted and created a peri-device leak (PDL) greater then 5mm around the device. There is no further information at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50803395 ↗
• InjurySep 11, 2026Failure to Seal

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50739953 ↗
• MalfunctionSep 4, 2026Device Difficult to Setup or Prepare; Device Contaminated During Manufacture or Shipping; Physical Resistance/Sticking

  It was reported that contamination occurred.During opening of the packaging and preparation of the 40mm WATCHMAN FLX Pro Delivery System (WDS), the device was found to be glued to the delivery system and could not be prepared or deployed as intended. A new 40mm closure device was opened and implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602075 ↗
• InjurySep 4, 2026Material Deformation; Migration; Failure to Seal

  Patient problems: Stroke/CVA; Thromboembolism

  MAUDE report 50600204 ↗
• InjuryAug 17, 2026Failure to Seal

  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 40mm WATCHMAN FLX Pro 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.Nine (9) months post procedure it was noted that the closure device had a leak. The physician scheduled a closure procedure for a future date. There were no other complications that were reported to have occurred.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50278446 ↗
• DeathMay 19, 2026Off-Label Use

  It was reported patient death occurred. A patient with a previously implanted WATCHMAN device (implanted in 2020) was found to have a thrombus in the left atrium and was scheduled for a thrombectomy procedure. During the procedure, the physician utilized a WATCHMAN TruSteer Access System (WAS), a 40 mm WATCHMAN FLX Pro LAA Closure Device and Delivery System (WDS), and a Flow Runner Aspiration System for thrombus removal. The physician intended to use the WATCHMAN FLX Pro Closure Device off label as a filter in the aortic arch. During the course of the procedure, the thrombus was dislodged and migrated from the left atrium, with the WATCHMAN FLX Pro Closure Device capturing it within the aorta while functioning off label as a filter. The thrombus was observed to suddenly dislodge from the WATCHMAN FLX Pro Closure Device and was no longer visualized. Immediately following this, the patient developed ST segment elevation along with a decline in blood pressure and heart rate. Chest compressions were initiated, however, despite resuscitative efforts, the patient died.

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes

  MAUDE report 25222678 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CEREBRAL VASCULAR ACCIDENT. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) AND A 40MM WATCHMAN FLX PRO 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) HOURS POST PROCEDURE THE PATIENT EXPERIENCED A CEREBRAL VASCULAR ACCIDENT. THE PATIENT WAS GOING TO BE TRANSFERRED TO ANOTHER HOSPITAL FOR STROKE MANAGEMENT. THERE WERE NO OTHER COMPLICATIONS OR TREATMENTS THAT WERE REPORTED TO HAVE OCCURRED AS A RESULT OF THIS EVENT.

  Patient problems: Stroke/CVA

  MAUDE report 24942013 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CARDIAC PERFORATION, PERICARDIAL EFFUSION AND CARDIAC TAMPONADE OCCURRED. A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE WAS BEING PERFORMED CONCOMITANTLY FOLLOWING ABLATION PROCEDURES. A WATCHMAN FXD CURVE ACCESS SYSTEM (WAS) AND A 40MM WATCHMAN FLX PRO LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED FOR USE. AFTER ONE DEPLOYMENT WITH THE DEVICE THERE WAS ONE RECAPTURE. A SECOND DEPLOYMENT IN THE APPENDAGE WAS COMPLETED. CONTRAST WAS USED AND NO LEAKS WERE NOTED AND THE POSITION, ANCHOR, SIZE AND SEAL (PASS) CRITERIA WAS MET. DURING THE FINAL MEASUREMENTS, THE PHYSICIAN WAS NOTIFIED OF LOW BLOOD PRESSURE. THE PHYSICIAN DID A SWEEP WITH THE INTRACARDIAC ECHO (ICE), AND A PERICARDIAL EFFUSION WAS FOUND ON THE RIGHT SIDE. THE PHYSICIAN DECIDED TO RELEASE THE DEVICE AND STARTED A PERICARDIOCENTESIS. BLOOD WAS STILL COLLECTING IN THE PERICARDIAL SPACE. CARDIOVASCULAR SURGERY WAS CONSULTED. EMERGENT SURGERY WAS NEEDED TO STOP THE BLEEDING. IT WAS NOTED THE PATIENT WAS ON PLAVIX AT THE TIME OF THE PROCEDURE. THERE WERE NO FURTHER COMPLICATIONS.

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

  MAUDE report 24913673 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PERICARDIAL EFFUSION OCCURRED. BEFORE THE PROCEDURE IT WAS NOTED THAT THE PATIENT HAD A SMALL EFFUSION MEASURING 0.8MM. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 40MM WATCHMAN FLX PRO CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED AFTER MULTIPLE REPOSITIONS IN THE APPENDAGE. THE PATIENT LEFT THE LABORATORY IN STABLE CONDITION WITH THE EFFUSION MEASURING THE SAME. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON (B)(6) 2026 IN STABLE CONDITION ON DUAL ANTIPLATELET THERAPY (DAPT). ON (B)(6) 2026, THE PATIENT RETURNED TO THE HOSPITAL WITH A PERICARDIAL EFFUSION AND EXHIBITING SIGNS OF CARDIAC TAMPONADE THAT NEEDED PERICARDIOCENTESIS AND BLOODY FLUID WAS DRAINED. THE PATIENT WAS DISCHARGED ON (B)(6) 2026 AND IS EXPECTED TO FULLY RECOVER.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 24830553 ↗
• DeathApr 9, 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 40MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED. THE PATIENT WAS DISCHARGED. THE PATIENT HAD NOT BEEN FEELING WELL, HAD SAT IN A CHAIR, BREATHING BECAME LABORED AND THEN DIED. THE SUSPECTED CAUSED WAS ACUTE ON CHRONIC HEART FAILURE WITH PRESERVED EJECTION FRACTION (HFPEF) AND KNOWN ADVANCED CORONARY ARTERY DISEASE (CAD).

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 24830529 ↗
• InjuryMar 24, 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 40MM WATCHMAN FLX PRO CLOSURE DEVICE WAS SELECTED TO BE USED ON (B)(6) 2026. DURING THE PROCEDURE THE CLOSURE DEVICE WAS IMPLANTED WITH NO LEAKS, PASSED THE TUG TEST, WELL POSITIONED AND SUFFICIENT COMPRESSION. THE PATIENT WAS DISCHARGED. DURING A ROUTINE 45-DAY FOLLOW UP TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE), THE PHYSICIAN AND IMPLANTING ELECTROPHYSIOLOGIST NOTED THAT THE CLOSURE DEVICE HAD SHIFTED AND A LEAK DEVELOPED. NO IMAGING HAS BEEN RETRIEVED YET AND NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674181 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A PERICARDIAL EFFUSION. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) AND A 40MM WATCHMAN FLX PRO LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED TO BE USED. THE PHYSICIAN POSITIONED THE WAS IN THE LAA OF THE PATIENT AND THEN INSERTED THE WDS. THE CLOSURE DEVICE WAS DEPLOYED AND RECAPTURED FOUR (4) TIMES, BUT THE CLOSURE DEVICE DID NOT MEET RELEASE CRITERIA. THE PHYSICIAN EXCHANGED THE WAS FOR A TRUSTEER WAS AND A NEW 40MM WDS. THE PHYSICIAN POSITIONED THE NEW WAS IN THE LAA OF THE PATIENT AND THEN INSERTED THE NEW WDS. THE CLOSURE DEVICE WAS DEPLOYED TWICE AND MET ALL RELEASE CRITERIA. THE CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED IN THE LAA OF THE PATIENT. DURING THE CHECK OF THE LAA A TRACE TO MILD PERICARDIAL EFFUSION WAS NOTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE AND NO INTERVENTION OR TREATMENT WAS REQUIRED. THE PHYSICIAN PLANNED TO PERFORM A TRANSTHORACIC ECHOCARDIOGRAM PRIOR TO DISCHARGE. THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY FROM THIS EVENT AND WILL BE DISCHARGED FROM THE HOSPITAL.

  Patient problems: Pericardial Effusion

  MAUDE report 24622726 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PERICARDIAL EFFUSION (PE) OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. THE LAA ANATOMY WAS DESCRIBED AS HAVING A WIDE OSTIUM WITH SHALLOW DEPTH. A 40MM WATCHMAN FLX PRO CLOSURE DEVICE AND DELIVERY SYSTEM (WDS) WAS INSERTED. MULTIPLE DEPLOYMENT ATTEMPTS OF THE WDS WERE MADE USING DIFFERENT ACCESS LOBES IN AN EFFORT TO ACHIEVE A DEPLOYMENT THAT MET RELEASE CRITERIA; HOWEVER, APPROPRIATE POSITIONING AND FIXATION COULD NOT BE ACHIEVED. DURING RECAPTURE OF THE WDS FOLLOWING THE 19TH DEPLOYMENT ATTEMPT, ECHOCARDIOGRAPHY DEMONSTRATED MOTION DISPLACING THE LAA TISSUE AND A PE WAS IDENTIFIED. THE PATIENT WAS MONITORED AND IMAGING CONFIRMED NO FURTHER INCREASE IN PE FLUID AND NO ADDITIONAL CHANGES. THE PHYSICIAN CONSIDERED THAT THE PE OCCURRED DURING THE FINAL RECAPTURE ATTEMPT AND CANCELLED THE PROCEDURE AS IT WAS NOT POSSIBLE TO MEET THE RELEASE CRITERIA AND ENSURE FIXATION DESPITE MULTIPLE ATTEMPTS.

  Patient problems: Pericardial Effusion

  MAUDE report 24534659 ↗
• InjuryMar 3, 2026Failure to Seal

  IT WAS REPORTED THAT PERI-DEVICE LEAK OCCURRED. A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE WAS PERFORMED AND A 40MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED. APPROXIMATELY FOUR MONTHS LATER A 3MM LEAK WAS IDENTIFIED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM. THE LEAK WAS COVERED USING NON-BOSTON SCIENTIFIC COILS AND PLUGS. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24500607 ↗
• InjuryFeb 27, 2026Failure to Seal

  IT WAS REPORTED VIA LITERATURE THAT TRANSIENT ISCHEMIC ATTACK AND DEVICE DID NOT SEAL OCCURRED. THIS LITERATURE ARTICLE DISCUSSES 22 CASES OF PERCUTANEOUS ASPIRATION THROMBECTOMY (AT) IN PATIENTS WITH PERSISTENT LEFT ATRIAL APPENDAGE (LAA) THROMBUS WITH SUBSEQUENT LAA CLOSURE. ASPIRATION THROMBECTOMY WAS PERFORMED EITHER MANUALLY, WITH A SYRINGE, OR MECHANICALLY WITH THE AID OF AN ASPIRATION PUMP. AFTER AT, LAA CLOSURE WAS PERFORMED WITH EITHER A WATCHMAN FLX, WATCHMAN FLX PRO, OR NON-BOSTON SCIENTIFIC LAA OCCLUDER. LAA CLOSURE WAS SUCCESSFUL IN ALL CASES. ONE PATIENT WHO WAS DISCHARGED WITH HALF-DOSE APIXABAN AFTER IMPLANTATION OF A 40MM WATCHMAN FLX PRO DEVICE EXPERIENCED A TRANSIENT ISCHEMIC ATTACK 3 WEEKS POST-IMPLANT. THE PATIENT'S APIXABAN DOSE WAS INCREASED TO 5MG TWICE DAILY. THE PATIENT'S 6-WEEK TRANSESOPHAGEAL ECHOCARDIOGRAM REVEALED THE PRESENCE OF A PERI-DEVICE LEAK. THE LEAK WAS SUBSEQUENTLY CLOSED AT 2 MONTHS.

  Patient problems: Transient Ischemic Attack

  MAUDE report 24475228 ↗
• InjuryFeb 19, 2026Failure to Seal

  REPORTED VIA PATIENT CALL CENTER. IT WAS REPORTED THAT A DEVICE LEAK OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 40MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED ON (B)(6) 2025. PRIOR TO RELEASE OF THE CLOSURE DEVICE, THE POSITION, ANCHOR, SIZE AND SEAL (PASS) CRITERIA WAS MET WITH A NOTE OF A 1.5MM LEAK ON THE SEAL. THERE WAS NO NOTED SHIFT BUT A POSSIBLE MISSED POSTERIOR LOBE. THE PATIENT HAD VERY DIFFICULT ANATOMY WITH CHALLENGING IMAGING WITH A LARGE ANTERIOR CHICKEN WING WITH HEAVY PECTINATE. THE BASELINE OSTIUM MEASURED 31MM WIDE BUT UPON DOING AN ANGIOGRAM IT WAS NOTED IT APPEARED MUCH WIDER AND IT WAS REALIZED THERE WAS AN ENTIRE LOBE MISSING THAT THE PHYSICIAN WAS HAVING A DIFFICULT TIME IMAGING ON TEE. WHEN RE-MEASURING THE PHYSICIAN REALIZED THE OSTIUM WAS CLOSER TO 34MM WIDE. A 40MM CLOSURE DEVICE WAS USED AND IT APPEARED TO BE SITTING AT THE OSTIUM WITH A 1.5MM LEAK. IT WAS DETERMINED THAT THIS WAS A SUITABLE POSITION. TEE IMAGING WAS EXTREMELY CHALLENGING THROUGHOUT THE CASE AND RELIED ON FLUOROSCOPY IMAGING FOR A MAJORITY OF THE PROCEDURE. THE PATIENT WAS DISCHARGED. THE PATIENT STATED THAT DURING THE SIX (6) WEEKS FOLLOW UP COMPU

  Patient problems: Pain

  MAUDE report 24391915 ↗
• InjuryFeb 4, 2026Failure to Seal

  IT WAS REPORTED THAT A DEVICE LEAK OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 40MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED ON (B)(6) 2025. DURING THE PROCEDURE AT THE TIME OF RELEASE, THE PHYSICIAN NOTED A SMALL LEAK. NO FURTHER INTERVENTION WAS PERFORMED AT THAT TIME AND THE PATIENT WAS DISCHARGED. THE PHYSICIAN PLANNED FOR CLOSURE OF THE LEAK, WHICH WAS SUCCESSFULLY PERFORMED ON (B)(6) 2026 WITH A NON-BOSTON SCIENTIFIC PRODUCT. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24261611 ↗
• InjuryFeb 4, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DEVICE EMBOLIZATION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED IN A LAA OF BROCCOLI MORPHOLOGY AND A 40MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED AFTER MEETING RELEASE CRITERIA. PRIOR TO DISCHARGE, DURING ROUTINE FOLLOW-UP ECHOCARDIOGRAM, THE CLOSURE DEVICE WAS OBSERVED TO HAVE EMBOLIZED INTO THE LEFT ATRIUM AND MITRAL VALVE. THE PHYSICIAN ATTEMPTED TO REMOVE THE CLOSURE DEVICE PERCUTANEOUSLY USING A NON-BOSTON SCIENTIFIC GRASPING DEVICE AND WAS ABLE TO GRAB THE CLOSURE DEVICE BUT WAS UNABLE TO COLLAPSE THE CLOSURE DEVICE TO PULL THROUGH THE INNER ATRIAL SEPTUM. THE PATIENT WAS TRANSFERRED TO SURGERY AND THE 40MM WATCHMAN FLX PRO CLOSURE DEVICE WAS EXCISED FROM THE ATRIAL SEPTUM AND THE INNER ATRIAL SEPTUM WAS REPAIRED. ADDITIONALLY, THE LAA WAS LIGATED VIA ATRICLIP. DURING THE EVENT THE PATIENT EXPERIENCED SYMPTOMS OF HYPOTENSION AND A VERY SHORT DURATION OF PULSELESS ELECTRICAL ACTIVITY. THE PATIENT IS RECOVERING IN THE INTENSIVE CARE UNIT BUT IS REPORTED TO BE DOING WELL FROM A CARDIAC STANDPOINT. THE PHYSICIAN SUSPECTED THE CAUSE OF THE EMBOLIZATION TO BE RELATED TO THE CLOSURE DEVICE BEING OVERSIZED, TOO PROXIMAL, AND DIS

  Patient problems: Low Blood Pressure/ Hypotension; Unspecified Tissue Injury

  MAUDE report 24258420 ↗
• InjuryJan 30, 2026Failure to Seal

  REPORTED VIA CLINICAL STUDY: IT WAS REPORTED DEVICE LEAKS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 40MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED. ON A ROUTINE FOLLOW UP, 12 MONTHS POST INDEX PROCEDURE, COMPUTED TOMOGRAPHY (CT) IMAGING REVEALED 2 LEAKS AROUND THE CLOSURE DEVICE, WITH THE FIRST LEAK MEASURING 8.2MM AND THE SECOND LEAK MEASURING 5.1MM. THERE WERE NO CORRECTIVE ACTIONS OR DIAGNOSTIC TESTS ASSOCIATED WITH THE FINDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221697 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTED VIA LITERATURE ARTICLE. IT WAS REPORTED THAT CEREBRAL VASCULAR ACCIDENT (CVA) OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 40MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED UNDER TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) GUIDANCE WITH APPROXIMATELY 22% COMPRESSION AND NO PERI-DEVICE LEAK NOTED AT THE TIME OF IMPLANT. AT 53 DAYS POST INDEX PROCEDURE, FOLLOW-UP COMPUTED TOMOGRAPHY (CT) IMAGING DEMONSTRATED A PERI-DEVICE LEAK (PDL) MEASURING APPROXIMATELY 2.2 MM WITH PARTIAL DENSE THROMBOSIS NOTED ON THE APPENDAGE SIDE OF THE CLOSURE DEVICE. THE PATIENT WAS TRANSITIONED TO DUAL ANTIPLATELET THERAPY IN RESPONSE TO THE EVENT. AT 297 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED WITH RIGHT-SIDED WEAKNESS AND WAS DIAGNOSED WITH AN ACUTE CVA OF ISCHEMIC ORIGIN, CONSISTENT WITH A CARDIOEMBOLIC SOURCE. REPEAT TEE DEMONSTRATED THE PDL WAS UNCHANGED IN SIZE WITH NO THROMBUS ON THE ATRIAL-FACING SURFACE OF THE CLOSURE DEVICE; HOWEVER, PARTIAL THROMBOSIS AND A MOBILE THROMBUS WERE VISUALIZED ON THE APPENDAGE SIDE OF THE CLOSURE DEVICE, ADJACENT TO THE PDL. IN THE PHYSICIANS OPINION THE THROMBUS FORMATION BEHIND THE CLOSURE DEVICE WITH EMBOLIZATION THROUGH

  Patient problems: Stroke/CVA; Thromboembolism

  MAUDE report 23924842 ↗
• InjuryDec 23, 2025Failure to Seal; Failure to Seal

  REPORTED VIA LITERATURE ARTICLE. IT WAS REPORTED THAT A DEVICE LEAK OCCURRED. A LEFT ATRIAL APPENDAGE (LAAC) CLOSURE PROCEDURE WAS PERFORMED IN 234 PATIENTS USING PREVIOUS-GENERATION WATCHMAN FLX (WMF) BETWEEN MAY-21 AND 14-FEB-24, AND IN 134 PATIENTS USING WMF-PRO BETWEEN 21-FEB-24, AND MAR-2025. THE BACKGROUND, PROCEDURAL AND SHORT-TERM OUTCOMES OF CONSECUTIVE 46 PATIENTS WHO UNDERWENT LAAC USING LARGE WMF-PRO DEVICES (35MM) AND COMPARED 35MM (33) WITH 40MM (13) WAS EVALUATED. THIS STUDY WAS APPROVED BY THE KURASHIKI CENTRAL HOSPITAL IRB AND ADHERED TO THE DECLARATION OF HELSINKI. DEVICE POSITION, ANCHORING, SEAL, SIZE, AND RELEASE WERE CONFIRMED BY TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND FLUOROSCOPY. SUCCESSFUL LAAC WAS DEFINED AS CORRECT DEVICE PLACEMENT WITH RESIDUAL FLOW LESS THAN OR EQUAL TO 5MM. SUCCESSFUL LAAC WAS ACHIEVED IN 97 PERCENT OF WMF CASES AND 100 PERCENT OF WMF-PRO CASES. FOLLOW-UP TEE OR CARDIAC CONTRAST (CCT) WAS PERFORMED THREE (3) MONTHS POST PROCEDURE. THE IMAGING FOLLOW-UP AT 3 MONTHS WERE PERFORMED. THERE WAS NO DIFFERENCE IN THE PERI DEVICE LEAK (PDL) OR PATENCY AT THREE (3) MONTHS WERE OBSERVED BETWEEN THE TWO GROUPS, AND NO DEVICE RELATED THROMBUS (

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23877063 ↗
• InjuryDec 22, 2025Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED USING TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING. A WATCHMAN FXD DOUBLE CURVE ACCESS SYSTEM (WAS) WAS INSERTED AND ADVANCED ALONG WITH A 40MM WATCHMAN FLX PRO CLOSURE DEVICE AND DELIVERY SYSTEM (WDS) WHICH WAS INSERTED AND DEPLOYED IN THE LAA. A PARTIAL RECAPTURE WAS PERFORMED THREE TIMES TO OPTIMIZE POSITIONING. DURING THE FOURTH DEPLOYMENT, TEE AT 90 DEGREES AND 135 DEGREES DEMONSTRATED APPROXIMATELY ONE-THIRD PROTRUSION ON THE INFERIOR AND POSTERIOR ASPECT; HOWEVER, ANCHOR STABILITY, DEVICE SIZING, AND SEAL WERE ACCEPTABLE, AND OVERALL DEVICE FRAME CONTACT WITHIN THE LAA APPEARED APPROPRIATE. DURING THIS RELEASE CRITERIA ASSESSMENT, HAZY ECHO WAS NOTED WITHIN THE CLOSURE DEVICE, AND A THROMBUS-LIKE FINDING MEASURING APPROXIMATELY 13.7 MM BY 8 MM WAS VISUALIZED AT THE THREADED INSERT/SCREW REGION. THE ACTIVATED CLOTTING TIME (ACT) AT THAT TIME WAS 275 SECONDS. ADDITIONAL HEPARIN WAS ADMINISTERED, AND ASPIRATION WAS PERFORMED THROUGH THE WDS WITH THE CORE WIRE CONNECTED. APPROXIMATELY 150 CC OF BLOOD WAS ASPIRATED, AND SEVERAL LARGE CLOTS WERE RETRIEVED. REPEAT TEE IMAGING DEM

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23863083 ↗
• InjuryDec 5, 2025Failure to Seal; Failure to Seal

  REPORTED VIA CLINICAL STUDY: IT WAS REPORTED THAT DEVICE LEAK OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 40MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED ON (B)(6) 2025. THE PATIENT WAS DISCHARGED. DURING THE ROUTINE 45 DAY FOLLOW UP COMPUTED TOMOGRAPHY (CT) IMAGING IDENTIFIED A 5.59MM PERI DEVICE LEAK. NO CORRECTIVE ACTIONS OR DIAGNOSTIC TESTS WERE PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23728365 ↗
• InjuryNov 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED AN IMPLANT EMBOLIZATION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 40MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED. THE FOLLOWING DAY POST INDEX PROCEDURE, A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED WHICH REVEALED THE CLOSURE DEVICE HAD EMBOLIZED OUT OF THE LAA AND INTO THE LEFT ATRIUM. THE PATIENT'S FAMILY IS DECIDING WHETHER OR NOT TO HAVE THE PHYSICIANS PERFORM HEART SURGERY. IT WAS FURTHER REPORTED THE PATIENT'S FAMILY DID NOT WANT TO RISK ANOTHER PROCEDURE, SO THE HOSPITAL IS DISCHARGING THE PATIENT WITH ANTICOAGULANT MEDICATION AS A RESPONSE TO THE EVENT. THE PATIENT HAS BEEN DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23677043 ↗

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,