Aveir™ LSCD201Recalls & reported problems

Summary

The FDA's MAUDE database contains 321 adverse event reports that list this exact device (DI 05415067038487), received between Dec 4, 2023 and Sep 30, 2026 — classified as 21 deaths, 189 injuries, 111 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (107 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 321 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Premature Separation

  It was reported the patient presented for implant procedure. During surgery, the ventricular Leadless Pacemaker (LP) exhibited high impedance and capture threshold during mapping. The LP was removed for inspection and prematurely separated from delivery catheter outside the patient. The helix on the LP was also stretched and bent upon inspection. The delivery catheter and LP were replaced to complete the procedure. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951002 ↗
• MalfunctionSep 30, 2026Separation Failure; Connection Problem; Activation Failure; Premature Separation

  It was reported that the patient presented in clinic for initial leadless pacemaker implant. During procedure, the catheter failed to go into long tether mode, resulting in it failing to release or dock the leadless pacemaker. Attempts to retract the leadless pacemaker resulted in it prematurely separating, resulting in embolism. A delivery catheter was used to retrieve the leadless pacemaker. Another catheter was used to successfully implant the leadless pacemaker. The patient was stable throughout.

  Patient problems: Embolism/Embolus

  MAUDE report 50950765 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented post-implant procedure for follow-up. Upon device interrogation, the right ventricular leadless pacemaker exhibited high capture threshold and pacing impedance. A small pericardial effusion was noted. As a result. the physician decided to extract the device. During extraction with the retrieval catheter, the pericardial effusion worsened. Pericardial window and cardiothoracic surgery were performed successfully as a result. The patient was stable.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 50948336 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during the implant procedure of a right atrium leadless pacemaker (RALP) that after fixating and transitioning to tether mode that there was low pacing impedance and high capture threshold. Angiography was performed and revealed that the helix of the RALP perforated the right atrial appendage. After some time, the physician elected to unscrew since the threshold was not decreasing, at this time, the patient's blood pressure dropped due to cardiac tamponade. The physician elected to abandon the implant procedure. The physician performed pericardiocentesis and the blood pressure stabilized. After about an hour the patient worsened again, and physician decided to open the chest and perform surgery to repair the wound. The patient was stable following the procedure.

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

  MAUDE report 50935828 ↗
• MalfunctionSep 24, 2026Separation Failure; Material Twisted/Bent; Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50891848 ↗
• InjurySep 23, 2026Connection Problem; Activation, Positioning or Separation Problem

  It was reported that the patient presented for an implant procedure. During the procedure, it was difficult to advance the introducer smoothly into the inferior vena cava. The physician felt it was too stiff. While advancing the introducer, the patient experienced a vasovagal reaction with hypotension. The physician attempted the leadless pacemaker implant; however, the delivery catheter could not be placed in the target location as the docking button and docking cap separated and forward pressure could not be applied. Medication was administered to address the vasovagal reaction and the procedure was aborted. There were no patient consequences and the patient was stable.

  Patient problems: Arrhythmia; Low Blood Pressure/ Hypotension

  MAUDE report 50869968 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50869548 ↗
• InjurySep 20, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Arrhythmia

  MAUDE report 50834839 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Vascular Dissection

  MAUDE report 50831626 ↗
• InjurySep 18, 2026Activation, Positioning or Separation Problem

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 50831562 ↗
• InjurySep 18, 2026Separation Failure

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50812867 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented for an implant procedure. During the procedure, the delivery catheter inadvertently contacted the heart causing ventricular tachycardia (VT). Anti-tachycardia Pacing was performed to convert, however, VT developed again and cardioversion was performed to terminate it. After the cardioversion, the device could no longer be successfully interrogated. The device was not used, and a new one was implanted successfully after removing electromagnetic interfering equipment. There were no patient consequences.

  Patient problems: Arrhythmia

  MAUDE report 50791707 ↗
• InjurySep 15, 2026Activation, Positioning or Separation Problem

  It was reported that the patient presented in clinic for Aveir leadless pacemaker (LP) implant procedure. During the implant, it was noted that the delivery catheter jumped forward inadvertently. Post-implant, it was noted the patient exhibited hypotension. Cardiac tamponade resulting from perforation was determined. A pericardiocentesis was performed. The LP was left implanted. The patient was noted to be unstable.

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

  MAUDE report 50777493 ↗
• InjurySep 12, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50744862 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the patient presented for implant procedure. During surgery, the atrial Leadless Pacemaker (LP) exhibited low pacing impedance and no capture during mapping. Contrast was injected due to suspicion of perforation and echocardiography confirmed the presence of a pericardial effusion. The LP was removed and pericardiocentesis was performed as well as life-saving measures. The patient's blood pressure gradually dropped and blood transfusion was performed. Thoracotomy was performed to repair the perforation. The patient was transferred to the Intensive Care Unit (ICU) in unstable condition.

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

  MAUDE report 50720999 ↗
• MalfunctionSep 10, 2026Premature Separation

  It was reported that the patient presented in clinic for Aveir leadless pacemaker (LP) implant procedure. During the implant, it was observed that the LP had prematurely separated from the delivery catheter at the point of fixation. As electricals were deemed acceptable, the LP was left in place. The patient status was unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50719038 ↗
• MalfunctionSep 9, 2026Activation Failure; Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50697011 ↗
• MalfunctionSep 9, 2026Premature Separation

  It was reported the patient presented for implant procedure. During surgery, the atrial Leadless Pacemaker (LP) premature separated from the delivery catheter after fixation during the tension test. The LP was implanted. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50695984 ↗
• InjurySep 9, 2026Activation, Positioning or Separation Problem

  It was reported that there was inadvertent movement of a right ventricular leadless pacemaker (LP) into the apex during mapping due to the delivery catheter. This resulted in unsatisfactory mapping measurements. Fluoroscopy confirmed the movement and echocardiography confirmed cardiac perforation, pericardial effusion, and cardiac tamponade. A thoracotomy was performed and no implant was completed. Patient was stable.

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 50684748 ↗
• MalfunctionSep 9, 2026Premature Separation

  It was reported that a right ventricular leadless pacemaker prematurely released from the delivery catheter after tether mode during implant. The leadless pacemaker was stable and had satisfactory measurements, so it was left in place. Patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50684192 ↗
• MalfunctionSep 3, 2026Fracture; Connection Problem; Activation Failure; Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50596549 ↗
• MalfunctionSep 3, 2026Break; Activation Failure; Premature Separation

  It was reported that the patient presented in clinic for an initial implant procedure of an Aveir system on (b)(6) 2026. While positioning the atrial leadless pacemaker (aLP), the physician had difficulties transitioning the delivery catheter (DC) into long tether mode and the aLP prematurely separated from the DC due to repeated unsuccessful tether mode activation attempts. The aLP dislodged and embolized to the pulmonary artery. The aLP was retrieved and the physician elected to implant a ventricular device only. Assessment of the DC noted the tether may have been fractured within the DC itself due to being unable to move the release knob. The patient was stable throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50589363 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient complained about chest pain after implant of their Aveir Right Atrial leadless pacemaker (LP). The patient was discharged and then presented into the emergency room the next day with chest pain. It was determined that the patient sustained pericarditis. No further intervention was performed. The patient's status was unknown.

  Patient problems: Discomfort; Unspecified Infection

  MAUDE report 50526774 ↗
• InjuryAug 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Arrhythmia

  MAUDE report 50510236 ↗
• InjuryAug 29, 2026Connection Problem

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 50510036 ↗

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