WATCHMAN FLX™ Pro M635WU60200Recalls & reported problems

Summary

The FDA's MAUDE database contains 147 adverse event reports that list this exact device (DI 00191506004583), received between Nov 16, 2023 and Sep 30, 2026 — classified as 10 deaths, 136 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (12 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 147 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported a pericardial effusion and cardiac tamponade occurred.A left atrial appendage closure (LAAC) procedure was performed, and a 20mm WATCHMAN FLX Pro LAA Closure Device was successfully implanted. Approximately five hours post procedure, the patient was experiencing unknown symptoms. A pericardial effusion with tamponade was noted. A pericardiocentesis was performed, removing an unknown amount of fluid from the patient.

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

  MAUDE report 50950744 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that pericardial effusion occurred. A left atrial appendage closure (LAAC) procedure was performed. A 20mm WATCHMAN FLX Pro LAA Closure Device was successfully implanted on (b)(6) 2026. The patient was noted to have a small appendage, but the physician was able proceeded with the procedure. There were no recaptures or repositions performed and there were no issues reported with the transeptal puncture. The patient was discharged. The patient was seen in the emergency department on (b)(6) 2026, due to shortness of breath and general weakness. Pericardial effusion was reported and the patient was hospitalized. Pericardiocentesis was completed on (b)(6) 2026, and 500cc of red fluid was drained. The patient was stable following the procedure and discharged the next day.

  Patient problems: Dyspnea; Muscle Weakness/Atrophy; Pericardial Effusion

  MAUDE report 50934193 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50924318 ↗
• InjurySep 24, 2026Migration

  It was reported that device migration occurred.A left atrial appendage (LAA) closure procedure was performed under transesophageal echocardiography (TEE) guidance. A 20mm WATCHMAN FLX Pro Delivery System and Closure Device (WDS) was positioned in the available deployment location due to limited appendage depth. Prior to release, the WDS met PASS criteria with approximately 10% to 15% compression, a successful tug test, no leak, and approximately one-third shoulder.Following release, the Closure Device shifted proximally and a larger shoulder was noted, most prominently in the 90 degree TEE view, causing it to no longer meet release criteria. Subsequent TEE assessment demonstrated no further movement of the Closure Device. No intervention was performed, and the plan is to reassess device position at the 45 day follow up.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50886890 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Memory Loss/Impairment; Pericarditis; Thrombosis/Thrombus

  MAUDE report 50868380 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50740062 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported a pericardial effusion and cardiac perforation occurred. A left atrial appendage closure (LAAC) procedure was being performed. A 20mm WATCHMAN FLX Pro LAA Closure Device & Delivery System (WDS) were selected for use. It was noted multiple deployments and recaptures occurred before the Closure Device was released and implanted into the LAA. Subsequently, a pericardial effusion and cardiac perforation occurred, and a pericardiocentesis was performed, draining 550cc of blood. The patient remained in the hospital for five days before discharging home.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 50734242 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 50721144 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that pericardial effusion and cardiac tamponade occurred. A left atrial appendage closure (LAAC) procedure was being performed. Prior to the procedure a pericardial effusion was noted on imaging. A WATCHMAN FXD Curve Access System (WAS) and a 24mm WATCHMAN FLX Pro LAA Closure and Delivery System (WDS) were initially selected for use. The WAS with VersaCross was posterior for the first transeptal puncture (TSP) and the physician had difficulty getting the sheath across. Another TSP was completed and the wire was put into the appendage and then exchanged for a pigtail catheter. Attempted the 24mm WDS, but it was too distally pinched, so it was exchanged for a 20mm WDS. The 20mm WATCHMAN FLX Pro was successfully implanted. The pericardial effusion increased in size at the end of the case and the patient blood pressure dropped. A pericardiocentesis was performed and 550cc of bright red blood was drained. The patient was given one bag of blood. The drain was left in place and the patient was sent to the intensive care unit (ICU) for observation. The drain has since been removed. The patient was reported as stable and was pending discharge.

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

  MAUDE report 50602453 ↗
• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pericardial Effusion

  MAUDE report 50599640 ↗
• InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that pericardial effusion occurred.A left atrial appendage (LAA) closure procedure was performed, and a 20mm WATCHMAN FLX Pro Closure Device was implanted. During the procedure, the patient was receiving antithrombotic therapy with Plavix and aspirin (ASA) per pre-procedure orders. Heparin was administrated and achieved an activated clotting time (ACT) of 436 seconds, which was higher than expected. A total of 7,000 units of IV heparin were administered, including 5,000 units prior to transseptal puncture (TSP) and an additional 2,000 units after TSP once the closure device was in the left atrium (LA). The patient had pre-imaging via computed tomography (CT). The procedure was performed under conscious sedation using nurse-administered fentanyl and midazolam (Versed), with guidance from mini transesophageal echocardiography (TEE). The patient tolerated the procedure well and the total procedure time was 20 minutes. One deployment was performed with no recapture required. The Position, Anchor, Size and Seal (PASS) criteria was met. No pericardial effusion was noted before or immediately after the procedure. During recovery, the patient complained of sharp pain with i

  Patient problems: Pain; Pericardial Effusion

  MAUDE report 50383799 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A THROMBUS. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN TRUSTEER ACCESS SYSTEM (WAS) AND A 20MM 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 IN THE PATIENT AND THE PHYSICIAN NOTED A THROMBUS ON THE FACE OF THE DEVICE. THE SHEATH WAS ASPIRATED THEN THE CLOSURE DEVICE WAS RECAPTURED AND REMOVED FROM THE PATIENT. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING SHOWED ANOTHER THROMBUS IN THE PATIENT THAT WAS ALSO ASPIRATED AND REMOVED FROM THE PATIENT. A NEW 24MM WDS WAS THEN USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH THE CLOSURE DEVICE SUCCESSFULLY IMPLANTED IN THE LAA OF THE PATIENT. THERE WERE NO OTHER COMPLICATIONS THAT WERE REPORTED TO HAVE OCCURRED DURING THE PROCEDURE. POST PROCEDURE THE PATIENT WAS ADMITTED TO THE HOSPITAL SINCE A CODE STROKE WAS CALLED. THE PATIENT WAS BACK TO BASELINE LATER THAT NIGHT. MAGNETIC RESONANCE IMAGING THE NEXT DAY SHOWED THAT THE PATIENT DID NOT EXPERIENCE A STROKE. THE PHYSICIAN BELIEVES THAT SOME OF THE PATIENTS PRESENTAT

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24706021 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION OCCURRED. A CONCOMITANT ABLATION WAS PERFORMED PRIOR TO THE LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE. A WATCHMAN FXD DOUBLE CURVE ACCESS SYSTEM (WAS) AND A 20 MM WATCHMAN FLX PRO LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED FOR THE LAAC. AT THE START OF THE ABLATION PROCEDURE, THE PHYSICIAN ATTEMPTED TO USE 4D NUVISION INTRACARDIAC ECHOCARDIOGRAPHY (ICE) ALONE. AFTER COMPLETING THE ABLATION, THE LAAC PROCEDURE BEGAN UNDER ICE GUIDANCE; HOWEVER, IMAGE QUALITY WAS SUBOPTIMAL, PROMPTING INSERTION OF A TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) PROBE. A BASELINE EFFUSION ASSESSMENT WAS NOT INITIALLY PERFORMED. FOLLOWING SEVERAL DEPLOYMENT ATTEMPTS WITH THE WDS, THE PHYSICIAN OBSERVED A PERICARDIAL EFFUSION NEAR THE RIGHT VENTRICULAR APEX, ALTHOUGH THE PATIENT REMAINED HEMODYNAMICALLY STABLE. IT WAS UNCLEAR WHETHER THE EFFUSION WAS PRE-EXISTING. THERE WAS NO INTERVENTION REQUIRED TO TREAT THE EFFUSION. THE 20MM CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED, AND THE PATIENT WAS KEPT OVERNIGHT FOR OBSERVATION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pericardial Effusion

  MAUDE report 24634188 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE WAS BEING PERFORMED. PRIOR TO THE PROCEDURE, A TRIVIAL PERICARDIAL EFFUSION WAS NOTED AT BASELINE ON IMAGING. A WATCHMAN ACCESS SYSTEM (WAS) AND A 20MM WATCHMAN FLX PRO LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED FOR USE. THE TRANSSEPTAL PUNCTURE (TSP) WAS PERFORMED AND WAS NOTED TO BE DIFFICULT DUE TO A THICK SEPTUM. THE 20MM WDS WAS DEPLOYED IN THE LAA. IMAGING WAS DIFFICULT TO VIEW IN THE MITRAL VIEW. WHILE REPOSITIONING FOR A HIGHER ANGLE, IT WAS NOTED THAT THERE WAS FLUID AROUND THE LEFT VENTRICLE (LV). THE PATIENT BLOOD PRESSURE WAS CHECKED AND NOTED TO BE 65 SYSTOLIC. A PERICARDIAL TAP KIT WAS PREPARED, AND A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS TAKEN. A PERICARDIAL EFFUSION WAS NOTED ON BOTH THE LV AND RIGHT VENTRICLE (RV). APPROXIMATELY 1L OF BLOOD WAS DRAINED TO TREAT THE EFFUSION. THE PATIENT STABILIZED AFTER 60 ML PROTAMINE WAS ADMINISTERED AND 1000ML OF BLOOD WAS DRAINED. THE BLOOD WAS TRANSFUSED BACK INTO THE PATIENT. TTE SHOWED IMPROVEMENT OF THE EFFUSION AND THE PATIENT BLOOD PRESSURE STABILIZED AT 120 SYSTOLIC. THE PATIENT WAS MONITORED FOR 15 MINUTES. T

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

  MAUDE report 24524327 ↗
• DeathMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DEATH OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED, AND A 20MM WATCHMAN FLX PRO CLOSURE DEVICE AND A WATCHMAN TRUSTEER ACCESS SYSTEM (WAS) WERE SELECTED TO BE USED. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO IMPLANT THE 20MM WATCHMAN FLX PRO CLOSURE DEVICE. AFTER THREE ATTEMPTS WITH LOW COMPRESSION THE PHYSICIAN TRIED THE WAS SHEATH WITH A NEW 20MM WATCHMAN FLX PRO CLOSURE DEVICE WHILE WAITING FOR A NON-BOSTON SCIENTIFIC (BSC) CLOSURE DEVICE TO ARRIVE. WITH THE WAS SHEATH, THE PHYSICIAN WAS STILL NOT ABLE TO GET THE 20MM WATCHMAN FLX PRO CLOSURE DEVICE TO HAVE ENOUGH COMPRESSION. THE WAS SHEATH AND THE 20MM WATCHMAN FLX PRO CLOSURE DEVICE WERE REMOVED FROM THE LEFT ATRIUM AND AFTER ABOUT 20-30 MINUTES, THE NON-BSC CLOSURE DEVICE WAS AVAILABLE. THE PHYSICIAN ATTEMPTED WITH THE ORIGINAL TRANSSEPTAL PUNCTURE BUT ENDED UP HAVING TO RE-STICK. THE NON-BSC 18MM CLOSURE DEVICE WAS IMPLANTED. AFTER THE PROCEDURE, DURING THE POST-PROCEDURE ECHOCARDIOGRAPHY, THE PATIENT DEVELOPED AGONAL BREATHING AND BEGAN TO DECOMPENSATE. CHEST COMPRESSIONS BEGAN. THE PHYSICIAN ATTEMPTED TO PLACE A DRAIN BEDSIDE BUT WAS UNABLE. THE PATIENT WAS TRANSFERR

  Patient problems: Pericardial Effusion

  MAUDE report 24519581 ↗
• InjuryFeb 26, 2026Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  REPORTED VIA PATIENT CALL CENTER. IT WAS REPORTED A PERICARDIAL EFFUSION OCCURRED POST PROCEDURE. A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE WAS BEING PERFORMED ON (B)(6) 2026. A WATCHMAN ACCESS SYSTEM (WAS) AND A WATCHMAN FLX PRO LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WAS SELECTED FOR USE. A PATIENT REPORTED TO THE WATCHMAN PATIENT CALL CENTER THAT SHE WAS INFORMED THAT SHE HAS AN LAA THAT WAS CHICKEN WING SHAPED. THE PATIENT REPORTED THAT HER PHYSICIAN ATTEMPTED TO IMPLANT THE SMALLEST WATCHMAN DEVICE BUT THAT IT WAS TOO SMALL AND HAD TO EXCHANGE FOR THE NEXT SIZE UP WHICH WAS THEN TOO LARGE. PATIENT REPORTED THAT SHE ULTIMATELY DID NOT HAVE A WATCHMAN IMPLANTED. PATIENT HAD AN ECHOCARDIOGRAM DONE POST PROCEDURE FOR ROUTINE EVALUATION. SHORTLY AFTER, AROUND 4:00PM SHE DROPPED HER CELL PHONE TO THE FLOOR, WHICH CAUSED HER HUSBAND TO NOTICE SHE WAS UNRESPONSIVE. PER PATIENT, HER BLOOD PRESSURE WAS FOUND TO BE 40/38MMHG. A CHEST TUBE AND DRAIN WERE PLACED QUICKLY WHILE SHE WAS ALERT AND WITHOUT ANESTHETIC AND PATIENT DESCRIBED THAT SO MUCH BLOOD WAS COMING OUT IMMEDIATELY. PATIENT STATED SHE WAS IN THE CARDIAC INTENSIVE CARE UNIT (ICU) FOR FOUR (4) DAYS AND HAD SAID DRAIN

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

  MAUDE report 24463797 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  REPORTED VIA PATIENT CALL CENTER. IT WAS REPORTED THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 20MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED ON (B)(6) 2025. THE PATIENT WAS DISCHARGED. THE PATIENT REPORTED INTO THE WATCHMAN PATIENT CALL CENTER THAT THEY WERE PLACED ON PLAVIX/ASPIRIN COMBINATION POST WATCHMAN IMPLANT. PATIENT NOTED THAT THE ROUTINE 45-DAY FOLLOW UP VISIT, IMAGING SHOWED DEVICE WELL SEATED AND NO EVIDENCE OF THROMBOSIS. THE PATIENT WAS TAKEN OFF PLAVIX AT THAT TIME. THE PATIENT SAID THAT THE SURGEON TOLD HER THAT HE DID NOT REQUEST/REQUIRE ANY ADDITIONAL FOLLOW UPS AT THE 90 DAY OR SIX (6) MONTH TIME POINTS. AT THE END OF YEAR 2025, THE PATIENT REPORTED SHE WENT IN FOR A COMPUTED TOMOGRAPHY (CT) SCAN REQUESTED BY HER CARDIOLOGIST UNRELATED TO THE WATCHMAN IMPLANT PROCEDURE AND WAS TOLD THAT THERE IS EVIDENCE OF THROMBOSIS IN THE LEFT ATRIAL APPENDAGE. PATIENT NOTED SHE DID NOT AND HAS NOT CONTACTED HER WATCHMAN SURGEON TO NOTIFY THE SURGEON OF WHAT WAS HAPPENING. PATIENT WAS DIRECTED TO REACH OUT TO THE WATCHMAN SURGEON TO LET HIM KNOW WHAT IS GOING ON. PATIENT TAKING ASPIRIN AT THIS TIME.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24403391 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PERICARDIAL EFFUSION (PE), CARDIAC TAMPONADE, AND CARDIAC PERFORATION OCCURRED REQUIRING SURGICAL INTERVENTION. THE PROCEDURE WAS ABORTED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED USING INTRACARDIAC ECHOCARDIOGRAPHY (ICE) GUIDANCE. A 20MM WATCHMAN FLX PRO CLOSURE DEVICE AND DELIVERY SYSTEM (WDS) WAS ADVANCED INTO A NARROW, PINCHED APPENDAGE ANATOMY. THE INITIAL DEPLOYMENT APPEARED FULLY EXPANDED BUT WAS POSITIONED DISTALLY, LEAVING PROXIMAL PECTINATE TISSUE UNCOVERED. THE PHYSICIAN PERFORMED PARTIAL RECAPTURED TO REPOSITION THE DEVICE MORE PROXIMALLY; HOWEVER, RESISTANCE WAS ENCOUNTERED AND THE WDS APPEARED CAUGHT ON TISSUE. MULTIPLE RECAPTURE AND REDEPLOYMENT ATTEMPTS WERE PERFORMED. A PE WAS THEN NOTED DEVELOPING AROUND THE TRANSVERSE SINUS REGION AND PROGRESSIVELY ENLARGED RAPIDLY ACCOMPANIED BY HYPOTENSION. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED AND A PERICARDIOCENTESIS WAS INITIATED, AND BLOOD WAS MANUALLY ASPIRATED AND RETURNED VIA THE GROIN ACCESS SITE. DESPITE THESE EFFORTS, THE PE CONTINUED TO ENLARGE, AND THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE, REQUIRING CARDIOPULMONARY RESUSCITATION (CPR) WHICH WAS PERFOR

  Patient problems: Arrhythmia; Bradycardia; Cardiac Perforation; Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion; Tachycardia; Ventricular Fibrillation

  MAUDE report 24345653 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A DEVICE RELATED THROMBUS. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) AND A 20MM 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. TWO (2) MONTHS POST PROCEDURE THE PATIENT CAME IN FOR THEIR TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) FOLLOW UP IMAGING PROCEDURE. THE TEE IMAGING SHOWED A SMALL ECHOGENIC STRUCTURE ON THE CLOSURE DEVICE. THE PHYSICIAN RESTARTED THE PATIENT ON A DAPT MEDICAL REGIMENT. FOUR (4) MONTHS LATER A FOLLOW UP TEE PROCEDURE SHOWED THAT THERE WAS NO THROMBUS PRESENT. ONE (1) YEAR POST PROCEDURE THE PATIENT HAD THEIR TEE FOLLOW UP PROCEDURE. THE TEE IMAGING SHOWED A LARGE MOBILE THROMBUS PRESENT. THE PATIENT WAS STARTED ON ELIQUIS AND ASPIRIN IN RESPONSE TO THIS EVENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24324291 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 20MM WATCHMAN FLX PRO CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED ON (B)(6) 2025. THE PATIENT WAS DISCHARGED. DURING A ROUTINE FOLLOW UP TRANSESOPHAGEAL ECHOCARDIOGRAPHY ON (B)(6) 2025 A DEVICE RELATED THROMBUS WAS NOTED ON THE LEFT ATRIUM (LA) SIDE. THE PATIENT WAS PLACED ON ELIQUIS BUT MAY SWITCH TO PRADAXA. A FOLLOW UP TEE IS SCHEDULED FOR (B)(6) 2026.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24323205 ↗
• InjuryFeb 11, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DEVICE EMBOLIZATION OCCURRED. A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE WAS PERFORMED ON (B)(6) 2025 WITH IMPLANT OF A 20MM WATCHMAN FLX PRO CLOSURE DEVICE. AT THE 45-DAY FOLLOW-UP, IMAGING WAS PERFORMED WHICH REVEALED THE CLOSURE DEVICE HAD EMBOLIZED TO THE DESCENDING AORTA. THE FOLLOWING DAY, THE CLOSURE DEVICE WAS PERCUTANEOUSLY EXPLANTED, AND A NEW 20MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24315620 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PERICARDIAL EFFUSION, PERICARDITIS AND HEMIDIAPHRAGM PARALYSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 20MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED ON (B)(6) 2025. POST PROCEDURE THE PATIENT DEVELOPED SOME CHEST PAIN. AT FIRST FOLLOW UP AFTER DISCHARGE, THE PATIENT WAS DETERMINED TO HAVE PERICARDITIS, AND SOME FLUID WAS NOTED IN THE PERICARDIAL SPACE. THE FLUID WAS NOT DRAINED, AND THE PERICARDITIS WAS TREATED WITH MEDICATION, BUT THE PATIENT DID CONTINUE TO EXPERIENCE PAIN AND DYSPNEA DURING THE TREATMENT. IN THE TIME FOLLOWING THE CLOSURE DEVICE IMPLANT A NON-BOSTON SCIENTIFIC (BSC) LYNX DEVICE WAS IMPLANTED IN THE DISTAL ESOPHAGUS. ON (B)(6) 2026, THE PATIENT REPORTED FOR A FOLLOW UP AND THE PATIENT HAS LEFT HEMIDIAPHRAGM PARALYSIS. THE PHYSICIAN REACHED OUT TO SHARE THE COMPLAINT AND ASKED IF THIS IS SOMETHING THAT HAS BEEN REPORTED AFTER A CLOSURE DEVICE PROCEDURE. THE PHYSICIAN WAS ALSO QUESTIONING IF IT IS A CONSEQUENCE OF THE PERICARDITIS. THE PHYSICIAN FOLLOWED UP A FEW HOURS LATER TO REPORT THAT A PULMONOLOGIST REPORTED THE LEFT HEMIDIAPHRAGM WAS MILDLY ELEVATED PRE CLOSURE DEVICE PROCEDURE. THE NON-BSC LYN

  Patient problems: Chest Pain; Dyspnea; Paralysis; Pericardial Effusion; Pericarditis

  MAUDE report 24292512 ↗
• DeathFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT DEATH OCCURRED. A CONCOMITANT PROCEDURE (ABLATION/LEFT ATRIAL APPENDAGE CLOSURE (LAAC)) WAS BEING PERFORMED ON A PATIENT WITH MULTIPLE COMORBIDITIES INCLUDING END STAGE RENAL DISEASE. LAB STAFF REPORTED THAT WHEN THE PATIENT ARRIVED AT TO THE HOSPITAL, SHE HAD A VERY HIGH SYSTOLIC BLOOD PRESSURE IN THE 200S WHICH REMAINED LABILE. A WATCHMAN TRUSTEER ACCESS SYSTEM (WAS) AND A 20MM WATCHMAN FLX PRO LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WAS SELECTED FOR USE FOR THE LAAC. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IMAGING WAS COMPLETED PRIOR TO STARTING THE PROCEDURE AND A SMALL PERICARDIAL EFFUSION AND PLEURAL EFFUSION WERE NOTED ON THE LEFT SIDE OF THE HEART NEAR THE APEX. THE APPENDAGE WAS DIFFICULT TO IMAGE AND THE PHYSICIAN STATED THE PATIENT HEART APPEARED SMALL. THE PHYSICIAN OBTAINED ACCESS FOR THE TRANSEPTAL PUNCTURE (TSP) UTILIZING A MID-MID STICK. ONCE TSP WAS COMPLETED, THE PHYSICIAN INSERTED THE FARADRIVE AND THEN A 35MM FARAWAVE CATHETER FOR THE ABLATION. A BOSTON SCIENTIFIC (BSC) ELECTROPHYSIOLOGY CLINICAL REPRESENTATIVE WAS THE MAPPER FOR THIS CASE. THE BSC REP WAS NOT ABLE TO VISUALIZE THE CHANGE FROM FLOWER TO BASKET ON THE MAPPING SYSTEM. THE

  Patient problems: Bradycardia; Cardiac Arrest; High Blood Pressure/ Hypertension; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 24272169 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  REPORTED VIA CLINICAL STUDY IT WAS REPORTED THAT TRANSIENT ISCHEMIC ATTACK OCCURRED. A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE WAS PERFORMED AND A 20MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED. APPROXIMATELY NINE (9) MONTHS POST-IMPLANT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH WEAKNESS AND SLURRED SPEECH. A COMPUTED TOMOGRAPHY SCAN WAS PERFORMED, AND THE PATIENT WAS DIAGNOSED WITH A TRANSIENT ISCHEMIC ATTACK. THE SUSPECTED CAUSE WAS CARDIOVASCULAR DISEASE PROGRESS. THE PATIENT WAS HOSPITALIZED IN RESPONSE TO THE EVENT. IT WAS FURTHER REPORTED THAT THE CORRECTIVE ACTION FOR THIS EVENT WAS ORAL ANTITHROMBOTIC AND OTHER ORAL MEDICATIONS WERE CHANGED/ADJUSTED. THE PATIENT WAS DISCHARGED NEXT DAY.

  Patient problems: Dysphasia; Muscle Weakness/Atrophy; Transient Ischemic Attack

  MAUDE report 24259730 ↗
• DeathFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  REPORTED VIA CLINICAL STUDY: IT WAS REPORTED THAT SEPSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE HAD PREVIOUSLY BEEN PERFORMED, AND A 20MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED. 11 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH SEVERE NECK PAIN FOLLOWING A GROUND-LEVEL FALL. CLINICAL WORKUP REVEALED POSITIVE BLOOD CULTURES FOR ENTEROCOCCUS FAECALIS. TRANSTHORACIC ECHOCARDIOGRAM (TTE) DEMONSTRATED POSSIBLE VEGETATION, AND MAGNETIC RESONANCE IMAGING (MRI) OF THE BRAIN SHOWED EVIDENCE OF SEPTIC EMBOLI, WITH ADDITIONAL IMAGING SUGGESTING POSSIBLE CERVICAL OSTEOMYELITIS. THE PATIENT WAS ADMITTED AND RECEIVED INTRAVENOUS ANTIBIOTIC MEDICATION. THE PATIENT REMAINED HOSPITALIZED FROM (B)(6) 2025, THROUGH (B)(6) 2025, FOR TREATMENT AND MONITORING RELATED TO SEPSIS AND ASSOCIATED FINDINGS. THE PATIENT WAS DISCHARGED AND THE EVENT IS CONSIDERED RESOLVED. THE SITE HAS INDICATED 'POSSIBLE' RELATIONSHIP OF THE EVENT WITH THE STUDY PROCEDURE. IT WAS FURTHER CORRECTED THE PATIENT WAS NOT DISCHARGED. THE PATIENT HAD A COMPLICATED MEDICAL PICTURE THAT INCLUDED SEPSIS SECONDARY TO INFECTIVE ENDOCARDITIS AND WAS NOT IMPROVING DURING THE INTE

  Patient problems: Cardiac Arrest; Embolism/Embolus; Endocarditis; Fall; Low Blood Pressure/ Hypotension; Neck Pain; Sepsis; Unspecified Infection

  MAUDE report 24251421 ↗

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