Aveir™ LSP201ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1,163 adverse event reports that list this exact device (DI 05415067040701), received between Jul 27, 2023 and Sep 30, 2026 — classified as 15 deaths, 340 injuries, 808 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (261 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 1,163 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Premature Separation

  Patient problems: Embolism/Embolus

  MAUDE report 50950795 ↗
• InjurySep 29, 2026Low impedance; Capturing 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 50935820 ↗
• MalfunctionSep 26, 2026Break; Stretched

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906494 ↗
• MalfunctionSep 25, 2026Incorrect Measurement

  It was reported that the patient presented for a follow-up in clinic. It was noted that the battery longevity of the atrial (aLP) and ventricular leadless pacemakers (vLP) exhibited a marked increase in length without any significant reason. It was noted the aLP was reprogrammed due to unrelated reasons, however, this change should not have had an effect on the battery's longevity. There were no consequences to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897430 ↗
• MalfunctionSep 24, 2026Signal Artifact/Noise

  It was reported that a patient complained of slow heart rates and "feeling generally unwell." Remote transmissions revealed multiple episodes of noise reversion on their right atrial leadless pacemaker, but consistent pacing. No intervention was completed yet. Patient was stable.

  Patient problems: Arrhythmia; Insufficient Information

  MAUDE report 50876643 ↗
• MalfunctionSep 23, 2026Failure to Interrogate; Under-Sensing; Device Dislodged or Dislocated

  It was reported that the patient presented for an implant procedure. During the procedure, the leadless pacemaker exhibited under-sensing and could no longer be interrogated after fixation. Fluoroscopy imaging showed that the device had dislodged and migrated into the groin. The device was retrieved and was not replaced. The patient was stable.

  Patient problems: Embolism/Embolus

  MAUDE report 50870785 ↗
• InjurySep 23, 2026Connection 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 50869965 ↗
• MalfunctionSep 23, 2026Inappropriate or Unexpected Reset

  It was reported that the patient presented for a follow-up in clinic. It was noted that the atrial leadless pacemaker (aLP) exhibited a software related reset which resolved on its own. The patient was asymptomatic. There were no reported consequences to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868112 ↗
• MalfunctionSep 15, 2026Separation Failure

  It was reported that the leadless pacemaker would not release from the delivery catheter after helix fixation during an initial implant procedure. The device was not used, and a new one was implanted successfully. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50776046 ↗
• MalfunctionSep 15, 2026Incorrect Measurement

  It was reported that the patient leadless pacemaker system prompted a diagnostic error upon interrogation indicating invalid diagnostics and intracardiac electrograms (EGM) data were detected. All diagnostic data was cleared as a result. It was also noted that the ventricular device exhibited high capture threshold. No intervention was performed. The patient condition was unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50775978 ↗
• MalfunctionSep 15, 2026Failure to Capture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50765961 ↗
• MalfunctionSep 14, 2026Failure to Interrogate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50762784 ↗
• MalfunctionSep 14, 2026Separation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50756649 ↗
• MalfunctionSep 11, 2026Separation Failure; Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736962 ↗
• MalfunctionSep 11, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736957 ↗
• MalfunctionSep 4, 2026Signal Artifact/Noise

  It was reported that a patient's right atrium leadless pacemaker (RALP) exhibited noise. No changes or interventions were reported. The patient condition was not reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50615103 ↗
• MalfunctionAug 26, 2026Over-Sensing; Pacing Problem

  It was reported that the patient presented remotely via Merlin.net. Upon review, it was found that the patient's leadless pacemaker (LP) exhibited far-field R-wave oversensing. The over-sensing resulted in inappropriate mode switch (AMS). No intervention was performed. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50458078 ↗
• MalfunctionAug 24, 2026Separation Failure

  It was reported that the patient presented in clinic for Aveir leadless pacemaker (LP) implant procedure. During the procedure, it was observed that the LP failed to separate from the delivery catheter at the point of fixation. The procedure was completed using an alternate LP on (b)(6)2026. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50417684 ↗
• MalfunctionAug 24, 2026Premature Discharge of Battery

  It was reported the patient presented for follow-up in clinic. Upon interrogation, it was discovered the atrial Leadless Pacemaker (LP) had triggered a Recommend Replacement Time (RRT) alert suggesting premature battery depletion had occurred. No changes or interventions were performed. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50413453 ↗
• InjuryAug 18, 2026Failure to Capture

  It was reported that the patient presented for a follow-up in clinic. Interrogation revealed high capture thresholds resulting in loss of capture on both the ventricular leadless pacemaker (vLP) and the atrial leadless pacemaker (aLP). The patient was asymptomatic. Additionally, it was noted the battery of the aLP depleted premature due to the high capture thresholds. The vLP and aLP were retrieved and a traditional pacemaker system was implanted. The patient was stable throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50311525 ↗
• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented in clinic for right atrial (RA) leadless pacemaker (LP) normal battery changeout procedure on (b)(6) 2026. During procedure, the RALP was unable to be retrieved with the use of retrieval catheter. And when a second non-Abbott retrieval catheter was used and being manipulated inside the RA, hypotension was noted due to a perforation followed by a pericardial effusion. The patient was transferred to patient support with pericardiocentesis performed. It was suspected that the perforation site was in the RA, but it was unknown whether the RALP or the right ventricular LP had caused the perforation. The RALP and RVLP both remained implanted. Patient condition was stabilized eventually and was transferred to the intensive care unit.

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

  MAUDE report 50310840 ↗
• MalfunctionAug 18, 2026Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50305516 ↗
• MalfunctionAug 11, 2026Capturing Problem

  It was reported that a right atrial leadless pacemaker exhibited high capture thresholds starting in (b)(6) 2026. Outputs were programmed higher to accommodate this change. Patient had no consequences and was stable throughout the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216812 ↗
• InjuryAug 11, 2026Failure to Interrogate; Stretched; Device Dislodged or Dislocated

  It was reported that routine post-implant procedure diagnostic imaging was performed and dislodgment of the right atrial (RA) leadless pacemaker (LP) into the pulmonary artery was observed. The RA LP was unable to be interrogated. A revision procedure was performed and the RA LP was successfully retrieved. Helix damage was noted on the RA LP, suspected to have occurred during the retrieval. The RA LP was replaced. The patient was in stable condition.

  Patient problems: Embolism/Embolus

  MAUDE report 50210233 ↗
• MalfunctionAug 7, 2026Stretched

  It was reported that the helix of the right atrial (RA) leadless pacemaker became stretched prior to fixation during the implant procedure. The RA LP was removed, and a new device was implanted to resolve the event. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50180377 ↗

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