Amulet™ STRBL-14F-075Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05415067049094), received between Mar 11, 2024 and Feb 13, 2026 — classified as 10 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026Air/Gas in Device

  IT WAS REPORTED THAT ON (B)(6) 2026, A 22MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT USING A AMULET¿ STEERABLE DELIVERY SHEATH. DURING DEVICE DEPLOYMENT, PHYSICIAN NOTICED AIR IN THE DEVICE LOADER TRAVELING TOWARD THE TOUHY AWAY FROM THE PATIENT. THE PHYSICIAN CONFIRMED WITH TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGER THAT NO AIR WAS SEEN. THE PATIENT WAS NOT IMPACTED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS REPORTED DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332244 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Positioning Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 28MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT USING A AMULET¿ STEERABLE DELIVERY SHEATH. THE IMPLANTER PREVIOUSLY TRIED 2 NON-ABBOTT DEVICE AND 2 DIFFERENT TRANSEPTALS. THE 28MM AMULET WAS ATTEMPTED AND DEPLOYED TWICE BUT DID NOT MEET CLOSE CRITERIA. THE 28MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS FULLY RECAPTURED AND A 25MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS DEPLOYED 3 TIMES BUT WAS UNSUCCESSFUL. BOTH DEVICE AND SHEATH WERE FULLY REMOVED FROM THE BODY. A MEMBRANOUS PIECE OF TISSUE NOTED ON THE SEPTUM UPON EVALUATING WITH DEVICE AND SHEATH OUTSIDE OF THE BODY, ATRIAL ENDOTHELIUM WAS NOTED ON DEVICE AND SHEATH. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23818431 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CRD_1064 - VERITAS, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, A 25MM AMPLATZER AMULET 2 WAS CHOSEN FOR IMPLANT WITH A 14F AMULET STEERABLE DELIVERY SHEATH. A FIGURE 8-STITCH WAS USED TO CLOSE ACCESS SITE. POST-PROCEDURALLY BUT PRIOR TO DISCHARGE, THE PATIENT DEVELOPED ANEMIA AND A HEMATOMA AT ACCESS SITE. THE PATIENT'S HEMOGLOBIN DROPPED BY 5 POINTS AND BECAME HYPOTENSIVE. THE PATIENT WAS TRANSFUSED 2 UNITS OF PACKED RED BLOOD CELLS. PATIENT ALSO DEVELOPED SIGNIFICANT ACUTE KIDNEY INJURY AND WAS PUT ON INTRAVENOUS DIURESIS. PATIENT TRANSITIONED OVER TO LASIX AND THEIR CONDITIONS IMPROVED. PATIENT WAS ADMITTED TO REHAB FOR FURTHER THERAPY.

  Patient problems: Anemia; Hematoma; Low Blood Pressure/ Hypotension; Renal Failure

  MAUDE report 22609482 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CRD_1064 - VERITAS, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025 A 28MM AMPLATZER AMULET 2 WAS CHOSEN FOR IMPLANT WITH A 14F AMULET STEERABLE DELIVERY SHEATH. POST-PROCEDURALLY, A HEMATOMA AT THE VASCULAR ACCESS SITE WAS NOTED AND THE PATIENT'S HEMOGLOBIN DROPPED FROM 15.1 TO 10.1 MG/DL. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT AND A FEMOSTOP WAS PLACED. THE PATIENT WAS DISCHARGED ON (B)(6) 2025. IT WAS ALSO REPORTED THAT ON (B)(6) 2025, THE PATIENT RECEIVED A BLOOD TRANSFUSION.

  Patient problems: Hematoma

  MAUDE report 22609168 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(6) VERITAS STUDY, PATIENT SITE ID: (B)(6) ,(B)(4). IT WAS REPORTED ON (B)(6) 2025, A 34MM AMPLATZER AMULET 2 OCCLUDER WAS SELECTED FOR IMPLANT USING A 14F AMPLATZER STEERABLE DELIVERY SHEATH. ON (B)(6) 2025, IT'S NOTED VIA COMPUTED TOMOGRAPHY SCAN THAT THE PATIENT HAD A SPONTANEOUS RECTUS SHEATH TEAR. THE DECISION WAS MADE TO HOSPITALIZE THE PATIENT OVERNIGHT FOR OBSERVATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hematoma

  MAUDE report 22484309 ↗
• MalfunctionMay 27, 2025Retraction Problem; Retraction Problem

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22091567 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6), PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, A 25MM AMPLATZER AMULET 2 WAS CHOSEN FOR PROCEDURE WITH A 14F AMULET STEERABLE DELIVERY SHEATH (ASDS). AFTER TRANSSEPTAL PUNCTURE WAS PERFORMED, THE 8.5F VERSACROSS TRANSSEPTAL SHEATH WAS EXCHANGED FOR THE 14F ASDS AND SUBSEQUENTLY PLACED INTO THE LEFT ATRIAL APPENDAGE (LAA). IT WAS THEN NOTICED THE PATIENT EXPERIENCED AN AIR EMBOLISM AND INFERIOR ST ELEVATIONS, TRANSIENT HYPOTENSION, AND SOME RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) DYSFUNCTION WAS NOTED. A RIGHT CORONARY ANGIOGRAM (RCA) WAS PERFORMED AND NO EVIDENCE OF OBSTRUCTION WAS REPORTED. THE ST ELEVATION WAS RESOLVED AND THE PATIENT WAS HEMODYNAMICALLY STABLE. THE PROCEDURE WAS CONTINUED BY CONNECTING THE 25MM AMPLATZER AMULET 2 TO THE 14F ASDS IN A CLOSED SYSTEM UNDERWATER TO ENSURE NO RETAINED AIR. THE 25MM AMPLATZER AMULET 2 WAS ATTEMPTED FOR IMPLANT BUT WAS DETERMINED NOT SUITABLE FOR PATIENT ANATOMY DUE TO CONCERNS WITH STABILITY AND A HIGH SHOULDER POSITION OF THE DEVICE IN HIGH ANGLE VIEWS. A DECISION WAS MADE TO RECAPTURE AND REPLACE THE DEVICE WITH A 22MM AMPLATZER AMULET 2. THE REPLACEMENT DEVICE WAS IMPLANTED AFTER PERFORMING A SUCCESS

  Patient problems: Air Embolism; Arrhythmia; Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes

  MAUDE report 21968585 ↗
• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON 21 FEBARUARY 2025, A 28MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT USING AN AMULET STEERABLE SHEATH. DURING PROCEDURE, THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVELS WERE ABOVE 250 ONCE THEY CROSSED INTO THE LEFT SIDE AND HEPARIN WAS ADMINISTERED. THREE ATTEMPTS WERE MADE TO DEPLOY THE 28MM DEVICE, AT THAT TIME IT WAS FULLY RECAPTURED AND THEY WERE GOING TO ATTEMPT TO TRY A 25MM DEVICE. ONCE 28MM DEVICE WAS FULLY RECAPTURED AND THEY WERE EVALUATING APPENDAGE A CIRCUMFERENTIAL EFFUSION WAS NOTED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE). A CARDIAC TAMPONADE WAS ALSO NOTED AND PROTAMINE WAS ADMINISTERED AS SOON AS EFFUSION WAS NOTED. A PERICARDIOCENTESIS WAS PERFORMED AT BEDSIDE AND 1100CC OF BLOOD WAS DRAINED. THE PATIENT REMAINED STABLE AFTER PROCEDURE; NO DEVICE WAS DEPLOYED. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 21632896 ↗
• InjuryDec 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 28MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT USING A 14F AMULET STEERABLE DELIVERY SHEATH. DURING PROCEDURE, THE ACTIVATED CLOTTING LEVELS (ACT) WERE ABOVE 250S AND BEFORE DEPLOYMENT POTENTIAL THROMBUS WAS NOTED AT END OF STEERABLE SHEATH VIA NUVISION 4D INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE SHAPE OF THROMBUS WAS SINGLE LONG FIBER LIKE STRAND AND THE SHEATH WAS IN THE PATIENT FOR A SIGNIFICANT PERIOD OF TIME. THE ENTIRE SHEATH REMOVED AND REPLACED. THE ACT WAS WITHIN THE RANGE AND ACT WAS CONTINUED TO BE MONITORED FOR REST OF CASE AND PHYSICIAN ADMINISTERED HEPARIN AS NEEDED. THE PATIENT WAS REPORTED STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21018811 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 31MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 14F AMULET STEERABLE DELIVERY SHEATH. THE PATIENT WAS IN SINUS RHYTHM. THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVELS WAS 269 SEC. TRANSSEPTAL PUNCTURE WAS INFERIOR POSTERIOR. DURING THE PROCEDURE THE DELIVERY SHEATH WAS IN THE LEFT ATRIUM DURING TRANSITION FROM INTRACARDIAC ECHOCARDIOGRAPHY (ICE) TO TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). CHEST COMPRESSIONS WERE PERFORMED. THE PATIENT PRESENTED WITH A PERICARDIAL EFFUSION. THE PATIENT UNDERWENT CARDIAC SURGERY TO TREAT THE PERICARDIAL EFFUSION. THE USER BELIEVED THE CHEST COMPRESSIONS CAUSED THE PERICARDIAL EFFUSION. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: Pericardial Effusion

  MAUDE report 20280890 ↗
• MalfunctionSep 13, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A 25MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR A PROCEDURE ON (B)(6) 2024 USING A 14F AMULET STEERABLE DELIVERY SHEATH. THE DEVICES WERE PREPARED PER IFU. DURING THE PROCEDURE, THE DEVICE WAS PARTIALLY RECAPTURED TWICE AS THE DEVICE WAS NOT COAXIAL IN THE LAA DURING THOSE DEPLOYMENTS. THE DEVICE WAS RELEASED FROM THE DELIVERY CABLE UPON THE THIRD DEPLOYMENT. UPON REMOVAL OF THE DELIVERY SHEATH FROM THE PATIENT, THE TIP OF THE DELIVERY SHEATH WAS OBSERVED TO HAVE SPLIT AND WAS NEARLY BROKEN OFF. THE PATIENT HAD NO TORTUOUS ANATOMY. THERE WAS NO DIFFICULTY INSERTING THE DELIVERY SHEATH INTO THE PATIENT NOR WAS THERE DIFFICULTY ADVANCING THE DELIVERY SHEATH THROUGH THE PATIENT ANATOMY. NO DAMAGE WAS VISIBLE ON THE DELIVERY SHEATH PRIOR TO REMOVAL FROM THE PATIENT. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20217553 ↗
• InjuryAug 26, 2024Improper or Incorrect Procedure or Method; Material Twisted/Bent; Positioning Problem; Improper or Incorrect Procedure or Method; Material Twisted/Bent; Positioning Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 25MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR IMPLANT USING A 14F AMPLATZER STEERABLE SHEATH. THIS DEVICE WAS UNABLE TO BE IMPLANTED AND WAS EXCHANGED FOR A NEW 22MM AMULET LEFT ATRIAL APPENDAGE OCCLUDER. DURING PROCEDURE, THE SHEATH SLIPPED INTO THE RIGHT ATRIUM (RA) THROUGH THE TRANSSEPTAL WHILE THE AMULET DEVICE WAS DEPLOYED IN THE APPENDAGE. THE LEFT ATRIAL PRESSURE DURING PROCEDURE WAS 18MMHG. AFTER SEVERAL FAILED ATTEMPTS TO RE-THREAD/MANIPULATE THE SHEATH BACK INTO THE LEFT ATRIUM (LA), THE DECISION WAS MADE TO PULL THE DEVICE BACK INTO THE SHEATH BY PULLING DIRECTLY OUT OF THE LEFT ATRIAL APPENDAGE. THE DEVICE WAS PARTIALLY RECAPTURED "MORE THAN 10 TIMES." AT SOME POINT DURING PROCEDURE, THE SHEATH WAS FOUND TO BE KINKED. THEN, TT WAS THOUGHT THAT THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. PERICARDIOCENTESIS WAS PERFORMED, HOWEVER NO FLUID WAS SEEN WHEN PULLED. THERE WAS NO PERICARDIAL EFFUSION WAS OBSERVED PRIOR TO PROCEDURE. IN ADDITION, CARDIAC TAMPONADE WAS NOT OBSERVED. THE PATIENT WAS SWEPT FOR EFFUSION AND THERE APPEARED TO BE A LOCALIZED PLEURAL EFFUSION THAT WAS POSSIBLY PRESENT AT BASELINE. IT IS

  Patient problems: Pleural Effusion

  MAUDE report 20063756 ↗
• MalfunctionJul 1, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A 25MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 14F AMULET STEERABLE DELIVERY SHEATH. THE DEVICES WERE PREPARED PER IFU. DURING IMPLANT IT WAS NOTED THAT THE DEVICE TOOK ON A DEFORMED SHAPE. THE DEVICE WAS REMOVED FROM THE PATIENT AND INSPECTED. IT WAS OBSERVED THAT A SMALL "RUBBER BAND" ITEM WAS SQUEEZING THE LOBE OF THE OCCLUDER. THE DEVICE AND DELIVERY SHEATH WERE REPLACED WITH A NEW 25MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER AND UNKNOWN DELIVERY SHEATH. THERE WERE NO ANGULATIONS OR KINKS NOTED IN THE DELIVERY SHEATH. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE. IT WAS UNKNOWN WHERE THE RUBBER BAND CAME FROM. IT WAS NOT NOTED DURING DEVICE PREPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19652063 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(4) - CATALYST IDE STUDY, PATIENT SITE ID: (B)(4). IT WAS REPORTED THAT ON 15 FEBRUARY 2024, A UNKNOWN AMPLATZER AMULET DELIVERY SHEATH WAS SELECTED FOR PROCEDURE. POST-IMPLANT IT WAS NOTED THAT THE PATIENT HAD BEEN DISCHARGED HOME AND HAD SNEEZED AND THE WOUND FROM THEIR PROCEDURE BEGAN BLEEDING. THE PATIENT WENT TO THE EMERGENCY DEPARTMENT, WHERE THEY RECEIVED A STITCHES AT THE INCISION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18876052 ↗