WATCHMAN® Access System M635TU20060Recalls & reported problems

Summary

The FDA's MAUDE database contains 634 adverse event reports that list this exact device (DI 08714729838203), received between Nov 15, 2016 and Feb 26, 2026 — classified as 27 deaths, 477 injuries, 130 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (59 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 634 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED UNDER TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) GUIDANCE WITH THE PATIENT UNDER GENERAL ANESTHESIA. THE WATCHMAN DOUBLE CURVE ACCESS SYSTEM (WAS) AND VERSACROSS CONNECT (VCC) SYSTEM WERE PREPARED FOR TRANSSEPTAL PUNCTURE (TSP). A HALF DOSE OF HEPARIN WAS ADMINISTERED PRIOR TO TSP, AND THE REMAINING HEPARIN WAS ADMINISTERED AFTER LEFT ATRIAL ACCESS WAS OBTAINED. TSP WAS PERFORMED AND WHILE REMOVING THE VCC DILATOR, MOBILE THROMBUS MATERIAL WAS OBSERVED ON TEE AT THE DISTAL END OF THE WAS WITHIN THE LEFT ATRIUM. THE MATERIAL WAS ASPIRATED BACK INTO THE WAS, AND THE SYSTEM WAS WITHDRAWN FROM THE PATIENT. UPON FLUSHING THE WAS ON THE BACK TABLE, ADDITIONAL CLOT MATERIAL WAS IDENTIFIED WITHIN THE SHEATH. THE PHYSICIAN ELECTED TO CANCEL THE PROCEDURE DUE TO CLOT FORMATION. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT FULLY RECOVERED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24454975 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT SUMMARIZES 1 SERIOUS INJURY EVENT FOR VESSEL PSEUDOANEURYSM. NOTE THAT MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT BUT ARE CAPTURED SEPARATELY UNDER REPORTING GUIDELINES. DEVICE RELATIONSHIP TO THE EVENTS REPORTED IS NOT PROVIDED.TYPE OF PROCEDURE: LEFT ATRIAL APPENDAGE CLOSURE.BOSTON SCIENTIFIC RECEIVED NOTIFICATION OF EVENTS FOR THE WATCHMAN LAAC DEVICE REPORTED IN THE LEFT ATRIAL APPENDAGE OCCLUSION REGISTRY (LAAO) REGISTRY, WATCHMAN FLX PRO SURPASS CLINICAL STUDY TO ASSESS LONG-TERM SAFETY AND EFFECTIVENESS OUTCOMES ASSOCIATED WITH THE USE AND IMPLANTATION OF THE WATCHMAN FLX PRO LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICE WITH DELIVERY SYSTEM IN A ROUTINE CLINICAL SETTING. PATIENT EVENTS WERE REPORTED AS EVENT TERMS WITH NO FURTHER DETAILED INFORMATION. MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT, BUT ARE CAPTURED SEPARATELY UNDER THE TERMS OF THE SUMMARY REPORTING GUIDELINES. DATA INCLUDES NEWLY IMPLANTED PATIENTS AND FOLLOW UP OF PATIENTS INCLUDED IN THE PREVIOUS DATA SET. UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, DATA IS ANONYMIZED BEFORE BEING TRANSMITTED TO BSC, THUS THERE ARE SIGNIFICANT LIMITATIONS TO BSC'S ABILITY TO CORRELATE THE DATA TO

  Patient problems: Pseudoaneurysm

  MAUDE report 22865943 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT SUMMARIZES 3 SERIOUS INJURY EVENTS FOR HEMATOMA. NOTE THAT MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT BUT ARE CAPTURED SEPARATELY UNDER REPORTING GUIDELINES. DEVICE RELATIONSHIP TO THE EVENTS REPORTED IS NOT PROVIDED.AGE RANGE: 69 TO 78 YEARSPATIENT SEX: 2 FEMALE; 1 MALE.TYPE OF PROCEDURE: LEFT ATRIAL APPENDAGE CLOSURE.BOSTON SCIENTIFIC RECEIVED NOTIFICATION OF EVENTS FOR THE WATCHMAN LAAC DEVICE REPORTED IN THE LEFT ATRIAL APPENDAGE OCCLUSION REGISTRY (LAAO) REGISTRY, WATCHMAN FLX PRO SURPASS CLINICAL STUDY TO ASSESS LONG-TERM SAFETY AND EFFECTIVENESS OUTCOMES ASSOCIATED WITH THE USE AND IMPLANTATION OF THE WATCHMAN FLX PRO LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICE WITH DELIVERY SYSTEM IN A ROUTINE CLINICAL SETTING. PATIENT EVENTS WERE REPORTED AS EVENT TERMS WITH NO FURTHER DETAILED INFORMATION. MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT, BUT ARE CAPTURED SEPARATELY UNDER THE TERMS OF THE SUMMARY REPORTING GUIDELINES. DATA INCLUDES NEWLY IMPLANTED PATIENTS AND FOLLOW UP OF PATIENTS INCLUDED IN THE PREVIOUS DATA SET. UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, DATA IS ANONYMIZED BEFORE BEING TRANSMITTED TO BSC, THUS THERE ARE SIGNIFICANT LIMITATION

  Patient problems: Hematoma

  MAUDE report 22864851 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT SUMMARIZES 1 SERIOUS INJURY EVENT FOR SURGICAL INTERVENTION. NOTE THAT MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT BUT ARE CAPTURED SEPARATELY UNDER REPORTING GUIDELINES. DEVICE RELATIONSHIP TO THE EVENTS REPORTED IS NOT PROVIDED. TYPE OF PROCEDURE: LEFT ATRIAL APPENDAGE CLOSURE. BOSTON SCIENTIFIC RECEIVED NOTIFICATION OF EVENTS FOR THE WATCHMAN LAAC DEVICE REPORTED IN THE LEFT ATRIAL APPENDAGE OCCLUSION REGISTRY (LAAO) REGISTRY, WATCHMAN FLX PRO SURPASS CLINICAL STUDY TO ASSESS LONG-TERM SAFETY AND EFFECTIVENESS OUTCOMES ASSOCIATED WITH THE USE AND IMPLANTATION OF THE WATCHMAN FLX PRO LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICE WITH DELIVERY SYSTEM IN A ROUTINE CLINICAL SETTING. PATIENT EVENTS WERE REPORTED AS EVENT TERMS WITH NO FURTHER DETAILED INFORMATION. MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT BUT ARE CAPTURED SEPARATELY UNDER THE TERMS OF THE SUMMARY REPORTING GUIDELINES. DATA INCLUDES NEWLY IMPLANTED PATIENTS AND FOLLOW UP OF PATIENTS INCLUDED IN THE PREVIOUS DATA SET. UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, DATA IS ANONYMIZED BEFORE BEING TRANSMITTED TO BSC, THUS THERE ARE SIGNIFICANT LIMITATIONS TO BSC'S ABILITY TO CORRELATE THE DATA T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22864625 ↗
• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBOSIS OCCURRED. THE PATIENT HAD BEEN TAKING ELIQUIS PRE-PROCEDURE. A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE WAS BEING PERFORMED USING TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING. GROIN ACCESS WAS OBTAINED, AND HEPARIN WAS GIVEN. THE FIRST ACTIVATED CLOTTING TIME (ACT) RESULT WAS THERAPEUTIC. A VERSACROSS CONNECT (VCC) KIT WAS SELECTED FOR USE. A WATCHMAN DOUBLE CURVE ACCESS SYSTEM (WAS) WAS INSERTED WITH THE VCC KIT. DURING TRANSSEPTAL PUNCTURE (TSP), A MOBILE THROMBUS WAS NOTED ON THE FOSSA OVALIS / SEPTUM GOING THROUGH A PATENT FORAMEN OVALE (PFO) AND IT SHOWED ON BOTH THE LEFT ATRIUM AND RIGHT ATRIUM. ASPIRATION OF THE THROMBUS WAS PERFORMED. A 27MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED. THE PROCEDURE WAS CONCLUDED, AND THE PATIENT WAS DISCHARGED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22738076 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT SUMMARIZES 5 SERIOUS INJURY EVENTS FOR BLOOD LOSS. NOTE THAT MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT BUT ARE CAPTURED SEPARATELY UNDER REPORTING GUIDELINES. DEVICE RELATIONSHIP TO THE EVENTS REPORTED IS NOT PROVIDED. AGE RANGE: 71 TO (B)(6) YEARS. PATIENT SEX: 4 FEMALE; 1 MALE. TYPE OF PROCEDURE: LEFT ATRIAL APPENDAGE CLOSURE. BOSTON SCIENTIFIC RECEIVED NOTIFICATION OF EVENTS FOR THE WATCHMAN LAAC DEVICE REPORTED IN THE LEFT ATRIAL APPENDAGE OCCLUSION REGISTRY (LAAO) REGISTRY, WATCHMAN FLX PRO SURPASS CLINICAL STUDY TO ASSESS LONG-TERM SAFETY AND EFFECTIVENESS OUTCOMES ASSOCIATED WITH THE USE AND IMPLANTATION OF THE WATCHMAN FLX PRO LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICE WITH DELIVERY SYSTEM IN A ROUTINE CLINICAL SETTING. PATIENT EVENTS WERE REPORTED AS EVENT TERMS WITH NO FURTHER DETAILED INFORMATION. MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT, BUT ARE CAPTURED SEPARATELY UNDER THE TERMS OF THE SUMMARY REPORTING GUIDELINES. DATA INCLUDES NEWLY IMPLANTED PATIENTS AND FOLLOW UP OF PATIENTS INCLUDED IN THE PREVIOUS DATA SET. UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, DATA IS ANONYMIZED BEFORE BEING TRANSMITTED TO BSC, THUS THERE ARE SIGNIFICANT

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22590411 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT SUMMARIZES 2 SERIOUS INJURY EVENTS FOR RETROPERITONEAL HEMORRHAGE. NOTE THAT MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT BUT ARE CAPTURED SEPARATELY UNDER REPORTING GUIDELINES. DEVICE RELATIONSHIP TO THE EVENTS REPORTED IS NOT PROVIDED. TYPE OF PROCEDURE: LEFT ATRIAL APPENDAGE CLOSURE BOSTON SCIENTIFIC RECEIVED NOTIFICATION OF EVENTS FOR THE WATCHMAN LAAC DEVICE REPORTED IN THE LEFT ATRIAL APPENDAGE OCCLUSION REGISTRY (LAAO) REGISTRY, WATCHMAN FLX PRO SURPASS CLINICAL STUDY TO ASSESS LONG-TERM SAFETY AND EFFECTIVENESS OUTCOMES ASSOCIATED WITH THE USE AND IMPLANTATION OF THE WATCHMAN FLX PRO LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICE WITH DELIVERY SYSTEM IN A ROUTINE CLINICAL SETTING. PATIENT EVENTS WERE REPORTED AS EVENT TERMS WITH NO FURTHER DETAILED INFORMATION. MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT, BUT ARE CAPTURED SEPARATELY UNDER THE TERMS OF THE SUMMARY REPORTING GUIDELINES. DATA INCLUDES NEWLY IMPLANTED PATIENTS AND FOLLOW UP OF PATIENTS INCLUDED IN THE PREVIOUS DATA SET. UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, DATA IS ANONYMIZED BEFORE BEING TRANSMITTED TO BSC, THUS THERE ARE SIGNIFICANT LIMITATIONS TO BSC'S ABILITY TO CORRELATE THE

  Patient problems: Retroperitoneal Hemorrhage

  MAUDE report 22589488 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT SUMMARIZES 1 SERIOUS INJURY EVENT FOR HEMATOMA. NOTE THAT MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT BUT ARE CAPTURED SEPARATELY UNDER REPORTING GUIDELINES. DEVICE RELATIONSHIP TO THE EVENTS REPORTED IS NOT PROVIDED. TYPE OF PROCEDURE: LEFT ATRIAL APPENDAGE CLOSURE. BOSTON SCIENTIFIC RECEIVED NOTIFICATION OF EVENTS FOR THE WATCHMAN LAAC DEVICE REPORTED IN THE LEFT ATRIAL APPENDAGE OCCLUSION REGISTRY (LAAO) REGISTRY, WATCHMAN SURPASS CLINICAL STUDY TO ASSESS LONG-TERM SAFETY AND EFFECTIVENESS OUTCOMES ASSOCIATED WITH THE USE AND IMPLANTATION OF THE WATCHMAN FLX LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICE WITH DELIVERY SYSTEM IN A ROUTINE CLINICAL SETTING. PATIENT EVENTS WERE REPORTED AS EVENT TERMS WITH NO FURTHER DETAILED INFORMATION. MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT, BUT ARE CAPTURED SEPARATELY UNDER THE TERMS OF THE SUMMARY REPORTING GUIDELINES. DATA INCLUDES NEWLY IMPLANTED PATIENTS AND FOLLOW UP OF PATIENTS INCLUDED IN THE PREVIOUS DATA SET. UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, DATA IS ANONYMIZED BEFORE BEING TRANSMITTED TO BSC, THUS THERE ARE SIGNIFICANT LIMITATIONS TO BSC'S ABILITY TO CORRELATE THE DATA TO INFORMATION PREVIOUSLY

  Patient problems: Hematoma

  MAUDE report 22578325 ↗
• InjuryMay 13, 2021Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT A THROMBUS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. THE ACTIVATED CLOTTING TIME (ACT) WAS IN THE RANGE OF 200 TO 300 SECONDS AND THE PATIENT WAS ON WARFARIN AND STOPPED TAKING THIS TWO DAYS PRIOR TO THE PROCEDURE. THE IMPLANTING TEAM INITIALLY HAD DIFFICULTY ENGAGING THE SEPTUM AND UPON CROSSING OF THE SEPTUM, THE TEAM HAD DIFFICULTY EXCHANGING TO A DOUBLE CURVE WATCHMAN ACCESS SYSTEM (WAS) AS THE SEPTUM WAS REPORTED TO BE TOUGH. AFTER REPEATED ATTEMPTS WITH THE DILATOR, THE SEPTUM WAS SUCCESSFULLY CROSSED. UPON REMOVAL OF THE NON-BOSTON SCIENTIFIC WIRE, THROMBUS WAS IDENTIFIED VIA ECHOCARDIOGRAPHY ON THE SEPTUM AT THE SEPTAL CROSSING IN THE RIGHT ATRIUM AND ON THE TIP OF THE WAS. THE THROMBUS WAS REPORTED TO BE MOBILE. AN ATTEMPT WAS MADE TO ASPIRATE THE THROMBUS, HOWEVER, THIS WAS UNSUCCESSFUL. THE WAS PULLED BACK INTO THE RIGHT ATRIUM AND OUT OF THE BODY. ONCE REMOVED FROM THE BODY, AN ORGANIZED THROMBUS WAS IDENTIFIED ON THE OUTER SHEATH OF THE WAS. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS EXTUBATED. THERE WERE NO COGNITIVE DEFECTS AND THE PATIENT WAS NEUROLOGICALLY INTACT. THE PATIENT WAS DISCHARGED HOME THE SAME

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11822770 ↗
• InjuryApr 29, 2021Material Deformation; Material Deformation

  IT WAS REPORTED A KINK AND PERICARDIAL EFFUSION 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 30MM WATCHMAN 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 ACCES

  Patient problems: Pericardial Effusion

  MAUDE report 11749432 ↗
• InjuryMar 23, 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 BEING PERFORMED. A DOUBLE CURVE WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 33MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. AFTER THE TRANSSEPTAL PUNCTURE WAS PERFORMED AND THE WAS WAS PLACED ACROSS THE SEPTUM, THEY NOTICED SOME OBJECT ON THE TIP OF THE SHEATH OR THE NON-BOSTON SCIENTIFIC GUIDEWIRE THAT WAS IN THE LEFT ATRIUM. THE ACTIVATED CLOTTING TIME (ACT) WAS IN THE THERAPEUTIC RANGE AROUND 250 SECONDS. ASPIRATION WAS PERFORMED WITH A SYRINGE ON THE WAS. THEY DID NOT SEE ANY CHANGE ON ECHO AND THE FOREIGN BODY WAS STILL PRESENT. THE GUIDEWIRE WAS REMOVED AND AS THEY RETRACTED THE GUIDEWIRE THEY ASPIRATED THROUGH THE WAS. AT THE END OF THIS MANEUVER THE FOREIGN BODY WAS NOT SEEN AND THE PROCEDURE CONTINUED. THE DEVICE WAS SUCCESSFULLY IMPLANTED AND NO FURTHER INTERVENTIONS WERE NEEDED. THE ACT REMAINED ABOVE 300 SECONDS AFTER THE FOREIGN BODY WAS SEEN. THE PATIENT WAS CHECKED FOR ANY SIGNS OF STROKE OR TRANSIENT ISCHEMIC ATTACK AND NONE WERE SEEN OR NOTED BY THE PHYSICIAN. THE PATIENT IS DOING WELL WITH NO FURTHER ISSUES.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11556343 ↗
• InjuryFeb 4, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED BACK BLEED DID NOT OCCUR AND THE PROCEDURE WAS CANCELLED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. THE PATIENT HAD A THROMBUS ON THE TRANSSEPTAL GUIDEWIRE AND SHEATH, SO BOTH WERE REMOVED AND PRESSURE WAS HELD ON THE RIGHT FEMORAL VEIN. A SMALL HEMATOMA WAS NOTED SO PRESSURE WAS HELD. THE LEFT FEMORAL VEIN WAS USED, AND THE TRANSSEPTAL WAS SUCCESSFUL. A DOUBLE CURVE WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 27MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE 27MM DEVICE WAS UNDER COMPRESSED, SO A 30MM DEVICE WAS PREPPED. THE WAS SHEATH WAS GETTING AIR IN THE SHEATH AND WOULD NOT BLEED BACK SO A NEW DOUBLE CURVE WAS PLACED. THE 30MM DEVICE WAS INSERTED AND IT WAS NOTICED THE PATIENT HAD A DROP IN BLOOD PRESSURE (70 SYSTOLIC) AND THE SHEATH WAS STILL WAS NOT BLEEDING BACK. A LARGE HEMATOMA WAS FOUND IN THE RIGHT GROIN. THE 30MM DEVICE WAS REMOVED, AND THE SHEATH WAS BROUGHT TO THE RIGHT SIDE AND PROTAMINE WAS GIVEN. PRESSURE WAS HELD TO THE GROIN, AND 2 UNITS OF BLOOD WERE GIVEN. THE ESTIMATED BLOOD LOSS FROM THE PROCEDURE WAS 500-600CC AND ALL BLOOD LOSS WAS FEMORAL. THE PATIENT WAS STABLE TWO HOURS POST-PROCEDU

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 11282393 ↗
• MalfunctionJan 26, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED AIR WAS IN THE SHEATH AND THE PROCEDURE WAS CANCELLED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. THE PATIENT HAD A THROMBUS ON THE TRANSSEPTAL GUIDEWIRE AND SHEATH, SO BOTH WERE REMOVED AND PRESSURE WAS HELD ON THE RIGHT FEMORAL VEIN. A SMALL HEMATOMA WAS NOTED SO PRESSURE WAS HELD. THE LEFT FEMORAL VEIN WAS USED, AND THE TRANSSEPTAL WAS SUCCESSFUL. A DOUBLE CURVE WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 27MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE 27MM DEVICE WAS UNDER COMPRESSED, SO A 30MM DEVICE WAS PREPPED. THE WAS SHEATH WAS GETTING AIR IN THE SHEATH AND WOULD NOT BLEED BACK SO A NEW DOUBLE CURVE WAS WAS PLACED. THE 30MM DEVICE WAS INSERTED AND IT WAS NOTICED THE PATIENT HAD A DROP IN BLOOD PRESSURE AND THE SHEATH WAS STILL WAS NOT BLEEDING BACK. A LARGE HEMATOMA WAS FOUND IN THE RIGHT GROIN. THE 30 MM DEVICE WAS REMOVED, AND THE SHEATH WAS BROUGHT TO THE RIGHT SIDE AND PROTAMINE WAS GIVEN. PRESSURE WAS HELD TO THE GROIN, AND 2 UNITS OF BLOOD WERE GIVEN. THE PATIENT WAS STABLE TWO HOURS POST-PROCEDURE. THE PHYSICIAN FELT THAT THE AIR WAS CAUSED BY LOSS OF VOLUME CREATING A LOW PRESSURE SYSTEM IN THE

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11233441 ↗
• InjuryDec 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROMBUS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. THE PATIENT HAD BEEN TAKING WARFARIN AND THEIR INTERNATIONAL NORMALIZED RATIO (INR) WAS THERAPEUTIC ON THE DAY OF THE IMPLANT. THE TRANS-SEPTAL PUNCTURE WAS PERFORMED AND THE WATCHMAN ACCESS SYSTEM (WAS) WAS INSERTED INTO THE PATIENT. IT WAS NOTICED THAT THERE WAS A LARGE CLOT IN THE RIGHT SIDE OF THE HEART NEAR THE SEPTUM ATTACHED TO THE WAS. HEPARIN HAD BEEN ADMINISTERED AND THE ACTIVATED CLOTTING TIME (ACT) MEASURED 399 SECONDS. THE CLOT WAS ASPIRATED OUT. THE WAS WAS REMOVED AND A NEW WAS WAS USED TO CONTINUE THE PROCEDURE. A WATCHMAN LAA CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED IN THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL.

  Patient problems: Thrombosis

  MAUDE report 11003055 ↗
• InjuryDec 3, 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 BEING PERFORMED. 9,000 UNITS OF HEPARIN WERE ADMINISTERED PRIOR TO THE TRANSSEPTAL PUNCTURE (TSP). NO THROMBUS WAS SEEN IN THE LEFT ATRIUM. A WATCHMAN ACCESS SYSTEM (WAS) WAS PREPPED AND ADVANCED INTO THE LAA. A CONTRAST SHOT WAS GIVEN AND AN ACTIVATED CLOTTING TIME RESULTED AT 80. IMMEDIATELY THROMBUS WAS OBSERVED ON ECHO AT THE TIP OF THE SHEATH. THE THROMBUS WAS ASPIRATED AND CAME BACK ACROSS THE SEPTUM TO THE RIGHT SIDE. AT THIS TIME IT WAS DISCOVERED THE IV WAS NOT WORKING. ANOTHER 5,000 UNITS HAD BEEN GIVEN JUST AFTER THE TSP. THE PATIENT WAS WOKEN UP FOR A NEURO ASSESSMENT AND THE EXAM WAS WITHIN NORMAL LIMITS. THE CASE WAS ABORTED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT WILL RETURN IN TWO WEEKS TO REATTEMPT IMPLANT.

  Patient problems: Thrombosis

  MAUDE report 10942751 ↗
• MalfunctionDec 1, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE ACCESS SYSTEM SHEATH KINKED. 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. MULTIPLE RECAPTURES OF THE 30MM DEVICE WAS PERFORMED. THEY SWITCHED OUT THE WAS SHEATH TO ENSURE IT WAS NOT KINKED. UPON REMOVAL, IT WAS NOTED TO BE DEFORMED. A SECOND WAS WAS USED AND FINISHED THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10929426 ↗
• InjuryDec 1, 2020Adverse 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 BEING PERFORMED. THE PHYSICIAN ADVANCED A 27MM WATCHMAN LAA CLOSURE DEVICE AND DELIVERY SYSTEM (WDS) THROUGH THE WATCHMAN ACCESS SYSTEM (WAS). THE CLOSURE DEVICE AS PLACED AT THE OSTIUM OF THE LAA WITH A PERSISTENT LEAK AFTER THREE RECAPTURES. IT WAS DECIDED TO TRY A LARGER CLOSURE DEVICE. THE 27MM CLOSURE DEVICE WAS RECAPTURED, REMOVED AND REPLACED WITH A NON-BOSTON SCIENTIFIC PIGTAIL CATHETER. WHILE MAKING SEVERAL ATTEMPTS TO RE-ENGAGE THE LAA WITH THE PIGTAIL, IT WAS NOTED THE PIGTAIL EXITED OUTSIDE THE CARDIAC SPACE. A PERICARDIAL EFFUSION OCCURRED. THE PHYSICIAN CALLED THE CT SURGEON WHILE MANAGING THE PERICARDIAL EFFUSION. SURGERY WAS PERFORMED AND THE LAA WAS CLIPPED. THE PATIENT WAS DISCHARGED AND HAS MADE A FULL RECOVERY.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 10929241 ↗
• InjuryNov 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. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED. THE 6F PIGTAIL CATHETER WAS WITHDRAWN FROM THE WAS AND DURING THE ADVANCEMENT OF THE CLOSURE DEVICE, THE PATIENTS BODY AND THE WAS SUBSEQUENTLY MOVED. A CONTRAST INJECTION WAS PERFORMED AND AN EFFUSION WAS VISUALIZED BY FLUOROSCOPY AND CONFIRMED BY TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE PATIENT BECAME HYPOTENSIVE AND WAS GIVEN ALBUMIN AND FLUID BOLUS. FURTHERMORE, PROTAMINE WAS GIVEN AND THE WAS WAS REMOVED. THE PHYSICIAN PERFORMED PERICARDIOCENTESIS AND REMOVED 600MLS OF BLOOD FLUID. THE PATIENT REMAINED STABLE; HOWEVER, TEE CONFIRMED RE-ACCUMULATION OF FLUID IN THE PERICARDIAL SPACE. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM AND A DECISION WAS MADE TO PERFORM PERICARDIAL WINDOW SURGERY. THE PATIENT WAS HEMODYNAMICALLY STABLE AND INTUBATED. THE PROCEDURE WAS ABORTED AND THE PATIENT REMAINED STABLE POST-SURGERY AND AWAITS DISCHARGE DATE.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 10781505 ↗
• InjuryNov 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERFORATION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. WHILE THE PHYSICIAN WAS POSITIONING THE WATCHMAN ACCESS SYSTEM (WAS) IN THE APPENDAGE OF THE PATIENT THEY CAUSED A SLIGHT PERFORATION OF THE LAA. THE PATIENT WAS BROUGHT TO HAVE OPEN HEART SURGERY TO FIX THE PERFORATION. DURING SURGERY THE PERFORATION WAS TREATED AND THE LAA OF THE PATIENT WAS CLIPPED. THE PATIENT DID WELL FOLLOWING THESE EVENTS AND HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL.

  Patient problems: Cardiac Perforation

  MAUDE report 10769784 ↗
• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A THROMBUS ON THE TIP OF THE ACCESS SYSTEM. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE PHYSICIAN POSITIONED THE WAS IN THE LAA OF THE PATIENT AND OPENED THE HEMOSTATIC VALVE, BUT OBSERVED NO BLOOD BACK FLOW. THE PHYSICIAN CHECKED FOR KINKS AND ASPIRATED WITH NO BACK FLOW STILL. THE PHYSICIAN THEN CHECKED THE ECHOCARDIOGRAM IMAGING AND NOTED THAT THERE WAS A THROMBUS ON THE TIP OF THE WAS. THE PHYSICIAN ASPIRATED THE THROMBUS BACK INTO THE WAS AND THEN REMOVED THE WAS FROM THE PATIENT. THE PHYSICIAN USED A NEW WAS TO DEPLOY THE CLOSURE DEVICE IN THE LAA OF THE PATIENT. THIS DEVICE DID NOT MEET RELEASE CRITERIA AND DUE TO THE PATIENT ANATOMY THE PROCEDURE WAS ENDED WITHOUT IMPLANTING A DEVICE. THE PATIENT IS DOING FINE FOLLOWING THESE EVENTS AND NO OTHER COMPLICATIONS WERE REPORTED TO HAVE OCCURRED.

  Patient problems: Thrombosis

  MAUDE report 10717784 ↗
• InjuryOct 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBUS 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. A SMALL EFFUSION WAS NOTED PRIOR TO THE PROCEDURE. DURING THE PROCEDURE, THEY DEPLOYED THE CLOSURE DEVICE AND THE PATIENT'S BLOOD PRESSURE DROPPED SIGNIFICANTLY. THEY CHECKED AND NOTICED THE EFFUSION INCREASED SLIGHTLY (MOST LIKELY 1MM MORE THAN AT BASELINE). THEY RELEASED THE CLOSURE DEVICE AND GAVE PROTAMINE AND THE PATIENT'S PRESSURE WENT BACK TO NORMAL. AS THEY WERE REMOVING THE ACCESS SYSTEM, THEY NOTICED THROMBUS IN THE RIGHT ATRIUM. THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT AND HEPARIN WAS USED TO DISSOLVE CLOT ONCE THE PROTAMINE WAS WORN OFF. THE PATIENT WAS FINE AND WAS DISCHARGED THE FOLLOWING DAY.

  Patient problems: Thrombosis

  MAUDE report 10686354 ↗
• InjuryOct 7, 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. DURING THE ANGIOGRAM OF THE APPENDAGE, AN EFFUSION WAS NOTED AND THE PHYSICIAN PERFORMED PERICARDIOCENTESIS TO DRAIN 500 CC OF FLUID. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM AND THEIR APPENDAGE WAS CLIPPED. THE PATIENT REMAINED STABLE AND WAS DISCHARGED.

  Patient problems: Pericardial Effusion

  MAUDE report 10643505 ↗
• InjurySep 29, 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. THE TRANSSEPTAL PUNCTURE WAS PERFORMED AND IT WAS NOTED THAT THE SEPTUM WAS VERY THICK THROUGHOUT. A WATCHMAN SINGLE CURVE ACCESS SYSTEM (WAS) WAS INSERTED TO THE LEFT SIDE OF THE HEART AND PIGTAIL CATHETER WAS INSERTED. THERE WAS AN ATTEMPT TO FIND THE APPENDAGE UNSUCCESSFULLY AND THE PHYSICIAN SWITCHED TO A DOUBLE CURVE WAS. AFTER THE EXCHANGE, THE SHEATH AND THE PIGTAIL WERE ADVANCED INTO THE APPENDAGE AND AN ANGIOGRAPHY WAS TAKEN. IMMEDIATELY AFTER THE ANGIOGRAPHY, THE PATIENTS PRESSURE NOTICEABLY DROPPED. A TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) OF THE HEART WAS PERFORMED AND A SMALL EFFUSION WAS NOTED IN THE PERICARDIUM. THE PHYSICIAN REMOVED THE SHEATH AND CATHETER OUT OF THE BODY AND THE EFFUSION INCREASED TO 1CM. A PERICARDIOCENTESIS WAS PERFORMED AND AFTER 45 MINUTES, THE PATIENT WAS TRANSFERRED TO HAVE SURGERY. THE SURGEON NOTED A SMALL TEAR IN THE RIGHT ATRIUM TO INFERIOR VENA CAVA (IVC) JUNCTION AND THE RIGHT VENTRICLE. THE PHYSICIAN BELIEVED THE TEARS WERE NOT FROM THE WAS. THE PROCEDURE WAS ABORTED AND THE PATIENT REMAINED STABLE AND HAS SINCE BE

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 10602977 ↗
• InjurySep 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A THROMBUS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 24MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. AFTER THE TRANS-SEPTAL WAS PERFORMED, THE PATIENT WAS ADMINISTERED 15,000 UNITS OF HEPARIN. AN ACTIVATED CLOTTING TIME (ACT) OF 131 WAS REPORTED TEN MINUTES LATER. THE PHYSICIAN ASKED FOR ANOTHER ACT TO BE DRAWN AND CHECKED BECAUSE THE INITIAL VALUE WAS REMARKABLY LOW FOR THE AMOUNT OF HEPARIN GIVEN. ADDITIONAL 3,000 UNITS OF HEPARIN WAS ADMINISTERED. SUBSEQUENTLY, THE PHYSICIAN SUCCESSFULLY ENGAGED THE LAA WITH THE ACCESS SHEATH AND DEPLOYED A 24MM CLOSURE DEVICE. A THROMBUS WAS NOTED TO BE FORMING ON THE WAS AND WDS AS RELEASE CRITERIA WAS BEING ASSESSED. THE ANESTHESIOLOGIST NOTED A LARGE PUDDLE OF FLUID AND MEDICATION ON THE BED SIDE OF THE PATIENT AND REALIZED AN ISSUE OR FAILURE WITH THE IV SITE. EVENTUALLY, IT WAS DISCOVERED THAT THE PATIENT WAS UNABLE TO RECEIVE ANY HEPARIN AND ADDITIONAL 10,000 UNIT OF BOLUSES WAS SUCCESSFULLY ADMINISTERED THROUGH THE IV. THE WAS AND WDS WERE MONITORED WITH NO CHANGE TO THE THROMBUS. AN ACT OF 274 WAS DRAWN AND A

  Patient problems: Thrombosis

  MAUDE report 10600513 ↗
• MalfunctionSep 25, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT A DEVICE KINKED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE WAS WAS INSERTED AND PROPERLY POSITIONED IN THE LAA OF THE PATIENT. THE PHYSICIAN DEPLOYED A CLOSURE DEVICE BUT RELEASE CRITERIA WAS NOT MET. UPON ATTEMPTING TO FULLY RECAPTURE, THE WAS WAS KINKED AND THE CLOSURE DEVICE WAS UNABLE TO BE PULLED INTO THE SHEATH. EVENTUALLY, THE PHYSICIAN WAS ABLE TO FULLY RECAPTURE THE DEVICE INTO THE KINKED SHEATH AND REMOVED IT FROM THE BODY. THE PATIENT REMAINED STABLE AND NO EFFUSION DEVELOPED. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS DISCHARGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10588831 ↗

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