Amplatzer AmuletRecalls & reported problems across all models

We found 8 models of Amplatzer Amulet by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 1,493 adverse event reports in the FDA's MAUDE database, received between Jul 13, 2020 and Sep 25, 2026 — classified as 146 deaths, 1,186 injuries, 161 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (379 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Amplatzer Amulet problems

Amplatzer Amulet models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Amplatzer™ Amulet™ 9-ACP2-010-025

  System, appendage closure, left atrial
  43 deaths479 reports
• Amplatzer™ Amulet™ 9-ACP2-007-022

  System, appendage closure, left atrial
  29 deaths285 reports
• Amplatzer™ Amulet™ 9-ACP2-010-028

  System, appendage closure, left atrial
  33 deaths284 reports
• Amplatzer™ Amulet™ 9-ACP2-010-031

  System, appendage closure, left atrial
  11 deaths145 reports
• Amplatzer™ Amulet™ 9-ACP2-007-020

  System, appendage closure, left atrial
  15 deaths130 reports
• Amplatzer™ Amulet™ 9-ACP2-007-018

  System, appendage closure, left atrial
  6 deaths76 reports
• Amplatzer™ Amulet™ 9-ACP2-010-034

  System, appendage closure, left atrial
  6 deaths52 reports
• Amplatzer™ Amulet™ 9-ACP2-007-016

  System, appendage closure, left atrial
  3 deaths42 reports

Recent Amplatzer Amulet adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Difficult to Fold, Unfold or Collapse

  It was reported that on (b)(6) 2026, a 28mmAmplatzer Amulet Left Atrial Appendage Occluder was chosen for implant using a 14F Amplatzer delivery sheath. During the procedure, while deployment the physician noted that the device was not taking desired shape, so they have to retrieve the device back. The deformed device was never released from the delivery cable while inside the patient. There was no angulation or kink noted in the delivery system. There was no interaction with cardiac structures during deployment. The procedure was aborted. The patient remained hemodynamically stable throughout the procedure. There was no clinically significant delay in procedure and no adverse patient effects reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903118 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pericardial Effusion

  MAUDE report 50902964 ↗
• InjurySep 25, 2026Patient Device Interaction Problem

  It was reported that on (b)(6) 2026, a 25mm Amplatzer Amulet Left Atrial Appendage Occluder was implanted in the patient. During procedure, the patient's activated clotting time (ACT) levels were 250-274s and 14,000 units of initial Heparin dose, then additional 3000 Heparin administered after the first ACT resulted as 250. Post procedure, 45 day follow up transesophageal echocardiogram (TEE) showed a 1.5x1.0cm device related thrombus (DRT). The patient was non-compliant with taking Aspirin and Plavix, and completely did not take any of her Dual antiplatelet therapy (DAPT) medication. The patient was placed on warfarin after the DRT was found. Then, over (b)(6) the patient presented to another hospital with a stroke event. The DRT was noted to be smaller but still present at that time. The patient remains on warfarin due to the ability to monitor International Normalized Ratio (INR) levels closely for medication non-compliance. The patient was reported stable.

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 50897836 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 18mm Amplatzer Amulet Left Atrial Appendage Occluder was chosen for implant using a Amulet Steerable Delivery Sheath. During the procedure, the left atrial pressure was 13mmHg. The Amulet was implanted after one partial recapture. Post recovery, the patient developed pericardial effusion and a pericardiocentesis was performed. The patient was reported stable.

  Patient problems: Pericardial Effusion

  MAUDE report 50897637 ↗
• InjurySep 25, 2026Migration or Expulsion of Device

  It was reported that on (b)(6) 2026, a 34mm Amplatzer Amulet Left Atrial Appendage Occluder was chosen for a procedure using a 14F non-Abbott delivery system. The left atrial pressure at time of procedure was 16 mm/Hg. A non-Abbott device failed and physician chose 34mm Amulet as per transesophageal echocardiogram (TEE) and an angiography (angio). During procedure, the first deployment met CLOSE criteria but pulled out on tension test. The Amulet recaptured and redeployed with different orientation, met CLOSE criteria and did two, lengthy tension tests without movement. The device compression wasn¿t typical in the RAO/CAUD, so we changed the camera angle to the Right Anterior Oblique with cranial angulation (RAO/CRAN) and compression was Barrel/Roman Helmet. The Amulet looked good on release. Later in the day, it was reported that the Amulet had dislodged from appendage. The implanter believes the cause of embolization was the not typical compression in the Right Anterior Oblique with Caudal angulation (RAO/CAUD). They were able to snare the device out of the left atrium with no patient impact. The patient was stable throughout and left the Cath Lab in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897154 ↗
• InjurySep 25, 2026Patient-Device Incompatibility

  It was reported that on (b)(6) 2026, a 25mm Amplatzer Amulet Left Atrial Appendage Occluder was chosen for a procedure. The patient lost pressure once device released. A pericardiocentesis was performed and drained 750cc of blood from the pericardium. After draining 750cc patient became stable and pressures normalized. Next day, the physician mentioned, the patient ended up being sent to surgery and the device was extracted and their appendage was over-sewn. The cardiothoracic (CT) surgeon mentioned to physician that there was some trauma to the distal end of the appendage, and one of the stabilizing wires perforated the appendage. The patient was in the intensive care unit (ICU) and recovering.

  Patient problems: Perforation; Pericardial Effusion

  MAUDE report 50896799 ↗
• DeathSep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 28mm Amplatzer Amulet was chosen for implant. It was then reported on an unknown date that the patient passed away. Cause of death was not reported. No autopsy was performed.

  Patient problems: Insufficient Information

  MAUDE report 50875147 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that (b)(6) 2026, a 20mm Amplatzer Amulet Left Atrial Appendage Occluder was chosen for implant using a 12F Amplatzer Amulet Delivery Sheath. The patient had difficult anatomy and required a 2nd transseptal puncture. The septum was difficult to visualize by transesophageal echocardiogram (TEE). During procedure, the patient's activated clotting time (ACT) levels were 340s & 223s. The left atrial pressure at time of procedure was 3mmHG, a 500ml bolus was given to the patient. The Amulet was implanted and released in 5 mins including 2 partial recaptures. The patient was kept overnight in precaution. A small effusion was noted the morning following the implant. The patient remains stable and did complain of chest pain. They were prescribed colchicine and remain admitted for further monitoring. The patient is stable and the device remains in good implanted position.

  Patient problems: Angina; Pericardial Effusion

  MAUDE report 50817723 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that (b)(6) 2026, a 25mm Amplatzer Amulet Left Atrial Appendage Occluder was chosen for implant using a 14F Amplatzer Amulet Delivery Sheath. During procedure, the patient's activated clotting time (ACT) levels were 258s and12000 units of Heparin was administered. The left atrial pressure at time of procedure 14mmhg. The Amulet was implanted after multiple deployments. Post procedure, a stroke was called but then neurology ruled it out. A magnetic resonance imaging (MRI) and a computed tomography angiography (CTA) of the head were clear and neurology called it an absence seizure. The patient then overnight went into cardiac tamponade and a small circumferential pericardial effusion was noted. The patient was tapped with a pericardiocentesis and recovered well. The patient has a history of alpha 1 antitrypsin disease which implanter is speculating lead to the pericardial effusion. The patient required 3 additional days of hospitalization. The patient was reported stable and home.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 50817413 ↗
• InjurySep 18, 2026Migration or Expulsion of Device

  It was reported that on (b)(6) 2026, a 31mm Amplatzer Amulet Left Atrial Appendage Occluder was implanted in the patient. On follow up transthoracic echocardiogram (TTE) prior to discharge, it was noted that the Amulet device had embolized to the left ventricle (LV). The patient was stable without symptoms. The patient underwent a procedure to retrieve the embolized device via a retrograde aortic approach. The device was retrieved successfully. The patient remained hemodynamically stable throughout the time the device was discovered to be in the LV and was retrieved. There was no damage to the mitral valve or aortic valve was noted. There was no change to the patient's heart function post device retrieval was noted. The patient was kept overnight for monitoring.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817237 ↗
• InjurySep 18, 2026Migration or Expulsion of Device

  It was reported that on (b)(6) 2026, a 20mm Amplatzer Amulet Left Atrial Appendage Occluder was chosen in extremely complex anatomy previously failed by non-Abbott device. The device was partially recaptured two times and ultimately deployed and released in 15 minutes. The patient was kept overnight out of precaution due to implanter experience and by recommendation of the proctoring physician. Next morning, echocardiogram (ECHO) noted that the device no longer remained in its implanted position. A chest x-ray was ordered to locate its location, it dislodged from its implanted location and was identified in the descending aorta. The physician on service and rounding the hospital consulted with vascular surgery and deferred to surgery to retrieve the embolized device. On (b)(6) 2026, the device was successfully retrieved and the patient remained stable. The patient is stable and recovering in the hospital.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817178 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 25mm Amplatzer Amulet Left Atrial Appendage Occluder was implanted in the patient. On an Unknown date, a pericardial Effusion was noted in the patient.

  Patient problems: Pericardial Effusion

  MAUDE report 50775143 ↗
• InjurySep 11, 2026Patient Device Interaction Problem

  It was reported that on (b)(6) 2026, a 25mm Amplatzer Amulet Left Atrial Appendage Occluder was chosen for implant using an Unknown Delivery System. During procedure, just before unscrew the delivery cable from the LAA Amulet Occluder, there was seen a small thread-like thrombus on the delivery cable.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50733616 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6)2026, a 18mm Amplatzer Amulet Left Atrial Appendage Occluder was implanted in the procedure. Three weeks post Amulet Implant, a pericardial effusion was noted in the patient. A pericardiocentesis was performed and drained fluid successfully. The patient was reported stable and discharged to home.

  Patient problems: Pericardial Effusion

  MAUDE report 50733515 ↗
• InjurySep 11, 2026Migration or Expulsion of Device

  It was reported that on (b)(6) 2026, a 25mm Amplatzer Amulet Left Atrial Appendage Occluder was implanted in the patient. A routine follow-up examination was conducted on (b)(6) 2026, revealed that the occluder had embolized and was stably located in the left atrium. The occluder was subsequently successfully retrieved using a snare catheter, without causing any harm to the patient. The physicians suspect that the contractile left atrial appendage (LAA) may have displaced the occluder from its original position. The patient was in sinus rhythm. The patient was reported stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50733181 ↗

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