AVEIR™ LSP203ARecalls & reported problems

Summary

The FDA's MAUDE database contains 440 adverse event reports that list this exact device (DI 05415067051189), received between Oct 15, 2025 and Sep 30, 2026 — classified as 6 deaths, 140 injuries, 294 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (111 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 440 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949794 ↗
• MalfunctionSep 30, 2026Premature Separation

  It was reported that the patient presented in clinic for initial leadless pacemaker (LP) implant procedure. During procedure, the LP spontaneously released from the catheter. It was discovered that the tethers on the catheter were slightly misaligned despite the release knob being in the aligned position. The LP was implanted successfully. The patient had no adverse consequences due to the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949559 ↗
• MalfunctionSep 29, 2026Failure to Capture; Failure to Sense

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941294 ↗
• MalfunctionSep 29, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938318 ↗
• MalfunctionSep 29, 2026Failure to Capture; Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937652 ↗
• MalfunctionSep 29, 2026Inappropriate or Unexpected Reset

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936349 ↗
• MalfunctionSep 29, 2026Stretched

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935707 ↗
• MalfunctionSep 29, 2026Separation Failure; Connection Problem; Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926934 ↗
• MalfunctionSep 28, 2026Separation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926005 ↗
• MalfunctionSep 28, 2026Stretched; Use of Device Problem; Capturing Problem

  It was reported that the patient presented for an initial implant procedure of an atrial leadless pacemaker (aLP) on (b)(6) 2026. Upon fixation, the current of injury and capture thresholds were unacceptable and the physician elected to reposition the aLP at which time it was noted the helix stretched. The aLP was not used, and a new aLP was successfully implanted. The patient was stable throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916112 ↗
• MalfunctionSep 28, 2026Device Dislodged or Dislocated

  It was reported that the patient's atrial leadless pacemaker (aLP) dislodged. Further information was not provided.

  Patient problems: Embolism/Embolus

  MAUDE report 50915503 ↗
• InjurySep 28, 2026Device Dislodged or Dislocated

  It was reported that the patient presented for a post operation check and it was noted that their Leadless Pacemaker (LP) dislodged. The LP was explanted and successfully replaced. The patient was stable.

  Patient problems: Embolism/Embolus

  MAUDE report 50910823 ↗
• MalfunctionSep 28, 2026Failure to Capture; Use of Device Problem

  It was reported that the patient presented for initial implant. The Right Atrial (RA) leadless pacemaker (LP) exhibited loss of capture. The LP was repositioned; however, the physician abandoned the RA LP implant due to user concern. There were no patient consequences reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910709 ↗
• InjurySep 26, 2026Failure to Capture; Difficult or Delayed Positioning

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 50906475 ↗
• MalfunctionSep 25, 2026Inappropriate or Unexpected Reset

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905785 ↗
• DeathSep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient with implanted Right Ventricular and Right Atrial leadless pacemakers had passed away. The patient's cause of death was unknown. There were no allegations from a healthcare professional that the cause of death was related to an Abbott product or procedure.

  Patient problems: Insufficient Information

  MAUDE report 50900789 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the patient presented for follow-up with dyspnea. Chest X-ray confirmed a left pleural effusion associated with the implant of the atrial and ventricular Leadless Pacemaker (LP). A pleural drainage was performed. The pleural effusion improved and the patient was discharged.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Dyspnea

  MAUDE report 50899640 ↗
• MalfunctionSep 25, 2026Inappropriate or Unexpected Reset

  It was reported that during an implant procedure, the leadless pacemaker was observed to be in backup (BVVI) mode due to cardioversion. The device configuration was run up to resolve the event. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896200 ↗
• MalfunctionSep 25, 2026Inappropriate or Unexpected Reset

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892582 ↗
• MalfunctionSep 24, 2026Inappropriate or Unexpected Reset

  New information received noted a device reset was completed to address the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892172 ↗
• InjurySep 24, 2026Use of Device Problem; Device Dislodged or Dislocated

  It was reported that the patient presented in clinic for Aveir leadless pacemaker (LP) implant. During the procedure, it was noted that there was inadequate current of injury. It was elected to leave the LP in place. The following day, it was observed that the LP had dislodged and traveled to the pulmonary artery. The LP was retrieved. There were no patient consequences.

  Patient problems: Embolism/Embolus

  MAUDE report 50885113 ↗
• InjurySep 24, 2026Failure to Capture; Use of Device Problem; Low impedance

  It was reported that the patient presented for an initial implant procedure of an Aveir leadless system on (b)(6) 2026. The ventricular leadless pacemaker (vLP) was implanted uneventfully. Upon fixating the atrial leadless pacemaker (aLP), it was noted the capture thresholds were high, the pacing impedance was low, and there was no change in the current of injury. The aLP was repositioned with similar measurements noted with the added side effect of no capture due to the high thresholds. The physician opted for ventricular pacing only and elected to abandon the aLP. Post-procedure the patient reported symptoms of nausea, dizziness, and low blood pressure. Transthoracic Echocardiogram (TTE) revealed pericardial effusion in the atria with blood being localized to the area indicating a cardiac perforation. A pericardiocentesis was performed to remove the blood and the patient stabilized. No further intervention is planned.

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

  MAUDE report 50883333 ↗
• InjurySep 23, 2026Insufficient Device Problem Information

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

  MAUDE report 50876075 ↗
• MalfunctionSep 23, 2026Separation Failure; Connection Problem

  It was reported the patient presented for implant procedure. During surgery, the atrial Leadless Pacemaker (LP) was unable to be redocked to the delivery catheter after fixation. The tethers were cut on the delivery catheter and a single snare was used to retrieve the LP. Outside the body, the tether was unable to be removed from the docking button on the LP. A different LP was used to complete the procedure. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872134 ↗
• MalfunctionSep 23, 2026Difficult or Delayed Positioning; Stretched; Use of Device Problem; Low impedance; Connection Problem

  It was reported that the patient presented for an implant procedure. During the procedure, the device was difficult to maintain in contact with the tissue during fixation. Once fixated, it exhibited inadequate current of injury and low pacing impedance. While attempting to re-position it was difficult to re-dock the device into the delivery catheter, however, the physician eventually was able to unfix and retrieve. Upon inspection outside of the patient's body, the device's helix was noted to be sprung. The device was not used, and a new one was implanted. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870154 ↗

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