Aveir™ LSCD111Recalls & reported problems

Summary

The FDA's MAUDE database contains 248 adverse event reports that list this exact device (DI 05415067036384), received between Aug 23, 2022 and Sep 3, 2026 — classified as 49 deaths, 92 injuries, 107 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (101 reports).

2 other recalls cover devices cleared under the same FDA submission (P150035); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 248 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2026Material Fragmentation; Connection Problem; Activation Failure; Premature Separation

  During repositioning at initial implant of a right ventricular (RV) leadless pacemaker (LP), a docking issue was observed on the delivery catheter as the protective sleeve could not advance over the RV LP due to suspected tissue interference. The delivery catheter was then unable to go into tether mode. After multiple attempts, the RV LP prematurely separated from the delivery catheter and remains fixated following the release. Following the release, it was observed that only one tether was visible on the delivery catheter. The patient was stable with no consequences.

  Patient problems: Embolism/Embolus

  MAUDE report 50594673 ↗
• DeathAug 26, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the patient presented for implant procedure. During surgery, the patient experienced ventricular tachycardia requiring external defibrillation. The ventricular Leadless Pacemaker (LP) was implanted with normal parameters. An hour after surgery, the patient experienced ventricular fibrillation and deceased despite rescue efforts.

  Patient problems: Arrhythmia

  MAUDE report 50457942 ↗
• DeathAug 20, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that after fixation, loss of capture and low current of injury was observed on the right ventricular (RV) leadless pacemaker (LP). The LP was repositioned with the delivery catheter; however, the loss of capture persisted in the new location. At this point, low blood pressure was observed. An ultrasound was performed and a pericardial effusion resulting in tamponade was observed. Pericardiocentesis was performed, and the blood pressure rose. The patient was transferred to a different hospital for treatment. The patient unfortunately passed away. Additional information was requested but not yet received.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 50355047 ↗
• DeathAug 12, 2026Separation Failure

  During implant procedure, following the deflection test the right ventricular (RV) leadless pacemaker (LP) was not able to be separated from the catheter. Troubleshooting methods were performed in situ to release the RV LP but were unsuccessful. The catheter and RV LP were removed from the patient and force was applied to the catheter and RV LP and the RV LP was successfully released. The catheter and RV LP were not used and replaced to continue the procedure. During the next attempt to implant the replacement RV LP the patient experienced a decrease in blood pressure. Ultrasound imaging was performed which confirmed peritoneal bleeding. The patient was administered catecholamines to address the bleeding but this was not successful. The patient died during the procedure. A dissection or rupture was alleged. A new LP and delivery catheter was selected for implant. During positioning the patient experienced a decreased in blood pressure. An ultrasound was performed, however, no anomalies were observed. Catecholamines were administrated but did not stabilize the patient. A second ultrasounds was performed and abdominal bleeding was observed. Due to the patient¿s Do Not Resuscitate ord

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Vascular Dissection

  MAUDE report 50229722 ↗
• InjuryAug 12, 2026Activation, Positioning or Separation Problem

  It was reported that following a leadless pacemaker implantation procedure, a pericardial effusion and cardiac tamponade were identified via echocardiogram. The patient was transferred to intensive care while experiencing high heart rates. Its blood pressure then dropped prompting pericardiocentesis to be performed, and blood was drained from the pericardial space. The bleeding subsequently resolved. The patient received a blood transfusion, albumin, and noradrenaline support. The Aveir device system remained implanted. The patient's condition remained stable following treatment and was ultimately discharged.

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

  MAUDE report 50224176 ↗
• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented for an initial implant procedure of a ventricular leadless pacemaker (vLP) on (b)(6) 2026. During the procedure it was noted the patient had recurrent ventricular tachycardia (VT) which required cardioversion. The patient became unstable and the procedure was abandoned. The patient is currently in the intensive care united (ICU) on ventilator support.

  Patient problems: Arrhythmia

  MAUDE report 50149570 ↗
• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the patient presented for implant procedure. During surgery, the ventricular Leadless Pacemaker (vLP) was being positioned when blood pressure dropped. Ultrasound confirmed the presence of a pericardial effusion. The vLP was removed, pericardiocentesis was performed, and the implant attempt was abandoned. The patient was in stable condition.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 50130955 ↗
• MalfunctionJul 29, 2026Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50076274 ↗
• DeathJul 29, 2026Activation, Positioning or Separation Problem

  It was reported that the patient presented in clinic for Aveir leadless pacemaker (LP) implant procedure. During implant, the LP was noted to have perforated the cardiac tissue which was identified by the patient's drop in blood pressure. The perforation was noted to result in effusion and tamponade. Emergency pericardiocentesis and sternotomy were performed. The procedure was completed without implanting the LP on (b)(6) 2026. The patient deceased due to the perforation.

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

  MAUDE report 50075177 ↗
• DeathMay 20, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE CARDIAC PERFORATION RESULTED IN TAMPONADE.

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 25230763 ↗
• MalfunctionApr 23, 2026Premature Separation

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR LEADLESS PACEMAKER (LP) IMPLANT PROCEDURE. DURING THE PROCEDURE, THE LP PREMATURELY SEPARATED FROM THE CATHETER. AS THE LP WAS FIXED AT THE TIME, IT WAS ELECTED TO COMPLETE THE PROCEDURE WITHOUT FURTHER REPOSITIONING. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24968055 ↗
• InjuryApr 13, 2026Use of Device Problem

  DURING THE LEADLESS PACEMAKER (LP) SYSTEM IMPLANT PROCEDURE, DUE TO PATIENT'S SMALL HEART ANATOMY, IT WAS DIFFICULT TO ACCESS THE RIGHT VENTRICULAR (RV). WHEN THE LP WAS MANEUVERED INTO A GOOD POSITION IN THE RV, THE INTRODUCER WAS LOWERED AND THE LP POSITIONING WAS LOST. AT THAT TIME THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE RESULTING IN SYNCOPE. A MEDICATION WAS ADMINISTRATED TO STABILIZE THE PATIENT. THE LP SYSTEM WAS EXPLANTED AND THE PHYSICIAN ELECTED TO IMPLANT A TRADITIONAL PACEMAKER.

  Patient problems: Low Blood Pressure/ Hypotension; Syncope/Fainting

  MAUDE report 24854258 ↗
• DeathApr 3, 2026Adverse Event Without Identified Device or Use Problem

  DURING AN INITIAL IMPLANT ON (B)(6) 2026 OF A VENTRICULAR LEADLESS PACEMAKER (VLP), IT WAS REPORTED THAT THE PHYSICIAN HAD DIFFICULTIES ACCESSING A SUITABLE LOCATION FOR PACING. AFTER SEVERAL ATTEMPTS, A LOCATION WAS FOUND AND THE VLP WAS RELEASED FROM THE DELIVERY CATHETER (DC) AND SUCCESSFULLY IMPLANTED. POSTOPERATIVE ECHOCARDIOGRAPHY REVEALED PERICARDIAL EFFUSION, AND THE TEAM IMMEDIATELY PROCEEDED TO PERFORM A PERICARDIOCENTESIS. THE PATIENT ALSO SUFFERED FROM HYPOTENSION WHICH WAS RESOLVED WHEN THE PERICARDIAL FLUID WAS DRAINED AND THE ADMINISTRATION OF BLOOD PRESSURE MEDICATIONS. THERE WAS NO TAMPONADE NOTED. THE PATIENT LEFT THE CATHETERIZATION LAB IN STABLE CONDITION BUT SUBSEQUENTLY PASSED AWAY AFTER IT WAS REPORTED THAT HER CONDITION DETERIORATED. THERE IS NO ALLEGATION THAT THE PATIENT'S DEATH IS RELATED TO ANY ABBOTT PRODUCTS OR PROCEDURES. THE PHYSICIAN BELIEVES THE PATIENT'S ADVANCED AGE, AND AS A RESULT, A WEAKENED MYOCARDIUM, PLAYED A MAJOR FACTOR IN THE DEATH.

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

  MAUDE report 24781275 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING INITIAL IMPLANT PROCEDURE, PATIENT EXPERIENCED A DECREASE IN BLOOD PRESSURE AND CONTRAST REVEALED PERICARDIAL EFFUSION. THE PHYSICIAN SUSPECTED THE PERICARDIAL EFFUSION DUE TO CARDIAC PERFORATION OCCURRED WHILE REPOSITIONING THE DELIVERY CATHETER WITHOUT RE-ENGAGING THE PROTECTIVE SLEEVE DURING THE MAPPING OF THE RIGHT VENTRICLE (RV) LEADLESS PACEMAKER (LP). THE PERICARDIAL EFFUSION WAS DRAINED AND THE RV LP REMAINS IMPLANTED. THE PATIENT WAS IN STABLE CONDITION.

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

  MAUDE report 24772569 ↗
• DeathApr 2, 2026Adverse Event Without Identified Device or Use Problem

  DURING AN INITIAL LEADLESS PACEMAKER (LP) IMPLANT PROCEDURE, THE PHYSICIAN ELECTED TO IMPLANT VIA THE JUGULAR VEIN WITH A STIFF GUIDEWIRE. GUIDED BY ECHO AND THE INTRODUCER WAS INSERTED. WHILE ATTEMPTING TO MANEUVER THE DELIVERY CATHETER WITH THE LP INTO THE RIGHT VENTRICLE (RV), CONTRAST ON FLUOROSCOPY SHOWED THE DELIVERY CATHETER WAS NOT INSIDE THE ATRIUM BUT IN THE PERICARDIAL/PLEURA SPACE. A VESSEL PUNCTURE WAS SUSPECTED. THE INTRODUCER WAS REMOVED AND THE PATIENT'S BLOOD PRESSURE DECREASED AND A PERICARDIAL EFFUSION RESULTING IN A TAMPONADE WAS OBSERVED. A THORACOTOMY WAS PERFORMED AND THE PUNCTURED VEIN WAS IDENTIFIED AND FIXED. THE PATIENT WAS IN THE ICU AND STABLE FOLLOWING THE THORACOTOMY, HOWEVER, LATER PASSED AWAY.

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

  MAUDE report 24766663 ↗
• DeathMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHILE POSITIONING THE RIGHT VENTRICULAR (RV) LEADLESS PACEMAKER (LP), CONTRAST REVEALED A PERFORATION RESULTING IN EFFUSION AND TAMPONADE. PERICARDIOCENTESIS WAS PERFORMED TO RESOLVE THE EFFUSION AND TAMPONADE. FOLLOWING THIS, THE PATIENT EXPERIENCED CARDIAC ARREST. SINUS RHYTHM WAS RESTORED, BUT CARDIAC ARREST REOCCURRED. CARDIOPULMONARY RESUSCITATION WAS NOT SUCCESSFUL AND THE PATIENT PASSED AWAY.

  Patient problems: Arrhythmia; Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 24714992 ↗
• DeathMar 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR AVEIR LEADLESS PACEMAKER (LP) IMPLANT PROCEDURE. UPON FIXATION, IT WAS OBSERVED THAT CAPTURE THRESHOLD INCREASED AND HELD STEADY. IT WAS ELECTED TO REPOSITION THE DEVICE. BLOOD PRESSURE WAS OBSERVED TO FALL AND THE PATIENT WAS SYNCOPAL. ECHO REVEALED PERICARDIAL EFFUSION RESULTING FROM PERFORATION. PERICARDIOCENTESIS WAS PERFORMED TO DRAIN THE EFFUSION, AND THEN ASPIRATION WAS PERFORMED DUE TO DECLINING PATIENT CONDITION. THE PATIENT WAS PRONOUNCED DECEASED.

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

  MAUDE report 24664701 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A RIGHT VENTRICULAR LEADLESS PACEMAKER SHIFTED DURING THE SECOND MAPPING ATTEMPT IN THE APEX. THIS CAUSED PATIENT TO EXPERIENCE A CARDIAC PERFORATION AND PERICARDIAL EFFUSION, SEEN WITH CONTRAST IMAGING. THE PATIENT ALSO EXPERIENCED HEART DISCOMFORT AND DECREASED BLOOD PRESSURE. THE PHYSICIAN STOPPED THE IMPLANT AND PERFORMED PERICARDIOCENTESIS. THE PATIENT WAS STABLE.

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

  MAUDE report 24641065 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHILE MAPPING TO FIND AN OPTIMAL IMPLANT LOCATION FOR THE RIGHT VENTRICLE (RV) LEADLESS PACEMAKER (LP), LOW BLOOD PRESSURE WAS OBSERVED. AN ECHOCARDIOGRAM WAS PERFORMED AND REVEALED A CARDIAC PERFORATION RESULTING IN EFFUSION AND TAMPONADE. THE DEVICE WAS REMOVED FROM THE PATIENT. PERICARDIOCENTESIS AND AN ADDITIONAL SURGERY WERE PERFORMED TO RESOLVE THIS EVENT. THE PATIENT WAS STABLE.

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

  MAUDE report 24580884 ↗
• DeathMar 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR INITIAL IMPLANT PROCEDURE OF A RIGHT VENTRICULAR LEADLESS PACEMAKER WITH THE USE OF A DELIVERY CATHETER ON (B)(6) 2026. ON THE FOLLOWING DAY POST IMPLANT, THE PATIENT DECEASED DUE TO AN UNKNOWN CAUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24551944 ↗
• InjuryMar 2, 2026Obstruction of Flow

  IT WAS REPORTED THAT WHILE ENTERING THE RIGHT VENTRICLE, THE PROTECTIVE SLEEVE OF THE DELIVERY CATHETER EXHIBITED BALLOONING WHILE SHOOTING CONTRAST. THE DELIVERY CATHETER AND LEADLESS PACEMAKER (LP) WERE REMOVED. THE PATIENT THEN EXPERIENCED LOW BLOOD PRESSURE AND PERICARDIAL EFFUSION RESULTING IN TAMPONADE. PERICARDIOCENTESIS WAS PERFORMED TO RESOLVE THE EVENT. THE LP WAS SUCCESSFULLY IMPLANTED WITH A NEW DELIVERY CATHETER. THE PATIENT WAS IN STABLE CONDITION.

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

  MAUDE report 24489962 ↗
• InjuryFeb 27, 2026Connection Problem

  IT WAS REPORTED THAT DURING THE INITIAL IMPLANT PROCEDURE, THE RIGHT VENTRICLE (RV) LEADLESS PACEMAKER (LP) WAS DIFFICULT TO DOCK TO THE DELIVERY CATHETER. AFTER FIXATION AND RELEASE, THE LP BECAME LODGED HORIZONTALLY IN THE TRICUSPID VALVE. MULTIPLE ATTEMPTS TO RETRIEVE THE LP WERE MADE DUE TO DIFFICULTY ATTACHING IT TO THE RETRIEVAL CATHETER. WHEN RETRIEVING THE RV LP WITH THE RETRIEVAL CATHETER, THE RV LP PREMATURELY SEPARATED FROM THE RETRIEVAL CATHETER AND DISLODGED TO THE RIGHT ATRIUM. THE RV LP WAS ABLE TO BE RETRIEVED AND REPLACED TO RESOLVE THE EVENT. THE PROLONGATION OF THE PROCEDURE WAS CLINICALLY SIGNIFICANT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471864 ↗
• DeathFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  DURING THE LEADLESS PACEMAKER (LP) SYSTEM IMPLANT PROCEDURE VIA THE JUGULAR VEIN, FOLLOWING A MAPPING ATTEMPT WITH POOR ELECTRICAL SIGNALS, THE RIGHT VENTRICULAR (RV) LP WAS PULLED INTO THE PROTECTIVE SLEEVE AND RELOCATED TO THE NEW SITE IN THE SEPTAL REGION OF THE RV USING CONTRAST. THE PATIENT EXPERIENCED ASYSTOLE BEFORE THE SECOND MAPPING ATTEMPT. AN EXTERNAL PACER WAS INEFFECTIVE IN REVIVING THE PATIENT. THE LP WAS PROGRAMMED TO ATTEMPT TO STIMULATE THE PATIENT, HOWEVER THIS WAS UNSUCCESSFUL. CARDIAC MESSAGE WAS PERFORMED WHICH WAS UNABLE TO RESUSCITATE THE PATIENT AND THEY DIED. THE PHYSICIAN NOTED THAT THEY LP WAS VISIBLE ON IMAGING AND WITH NO FIXATION ATTEMPTED, THEY WERE SURE THEY DID NOT PERFORATE THE HEART.

  Patient problems: Arrhythmia; Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 24414855 ↗
• MalfunctionFeb 18, 2026Activation Failure; Premature Separation

  IT WAS REPORTED THAT DURING THE INITIAL IMPLANT PROCEDURE, AFTER FIXATION OF THE RIGHT VENTRICLE (RV) LEADLESS PACEMAKER (LP), THE DELIVERY CATHETER WAS UNABLE TO GO INTO TETHER MODE. DURING ATTEMPTS TO ENTER TETHER MODE, SPONTANEOUS RELEASE OF THE FIXATED RV LP OCCURRED. THE RV LP WAS EXPLANTED AND REPLACED USING A NEW DELIVERY CATHETER. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24382457 ↗
• DeathFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  DURING AN INITIAL LEADLESS PACEMAKER IMPLANT, DIFFICULTIES PASSING THE PATIENT'S TRICUSPID VALVE REPLACEMENT SYSTEM WERE ENCOUNTERED WITH THE DELIVERY CATHETER. AFTER SUCCESSFUL ENTRY INTO THE RIGHT VENTRICLE, A PERFORATION WAS DIAGNOSED AS THE PATIENT EXPERIENCED A LOSS OF HEMODYNAMIC STABILITY. PERICARDIAL DRAINAGE AND CARDIOPULMONARY RESUSCITATION WERE ATTEMPTED, HOWEVER, THE PATIENT PASSED AWAY.

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

  MAUDE report 24348025 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150035. One submission often covers many models, so check the product and lot details in each record.

• Z-2405-2026 · May 12, 2026 · Open, Classified
  Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
• Z-1695-2024 · Feb 5, 2024 · Open, Classified
  Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO