Aveir™ LSP112VRecalls & reported problems

Summary

The FDA's MAUDE database contains 1,626 adverse event reports that list this exact device (DI 05415067034472), received between Apr 22, 2022 and Sep 29, 2026 — classified as 73 deaths, 416 injuries, 1,137 malfunctions.

The most frequently reported specific device problem is “Stretched” (440 reports).

2 FDA recall records name this device's identifier, 2 still open.

1 other recall 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.

Recalls naming this device

1. Feb 15, 2025Open, Classified

   Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.

   Z-1557-2025 · Root cause: Process control · FDA record ↗

2. Feb 5, 2024Open, Classified

   Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.

   Z-1695-2024 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,626 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Stretched

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941350 ↗
• 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 50900826 ↗
• MalfunctionSep 25, 2026Positioning Failure; Stretched

  It was reported that during the implant of a right ventricle leadless pacemaker (RVLP) after fixating while performing the tug test it was discovered that the RVLP helix had stretched and deformed. The RVLP was not used and the physician elected to complete the procedure with a different RVLP. The patient condition was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899915 ↗
• MalfunctionSep 25, 2026Stretched; Capturing Problem

  It was reported that the patient presented for a leadless pacemaker (LP) implant procedure. The LP was repositioned multiple times on (b)(6) 2026 due to a high capture threshold, and Fluoroscopy revealed that the helix had become stretched. The LP was successfully replaced and the patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899874 ↗
• 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 50897426 ↗
• MalfunctionSep 23, 2026Device Dislodged or Dislocated

  Patient problems: Embolism/Embolus

  MAUDE report 50874825 ↗
• MalfunctionSep 23, 2026High impedance

  It was reported the patient presented for implant procedure. During surgery, the ventricular Leadless Pacemaker (LP) exhibited high pacing impedance after fixation. The physician elected to implant the LP. Post-procedure checks the following day showed continued high pacing impedance measurements. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872213 ↗
• MalfunctionSep 23, 2026Failure to Capture

  It was reported the patient presented post-implant procedure for follow-up. Upon interrogation, it was discovered the ventricular Leadless Pacemaker (LP) exhibited loss of capture due to increased capture thresholds. Programming changes were performed. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871840 ↗
• MalfunctionSep 23, 2026Inappropriate or Unexpected Reset

  It was reported the patient presented for implant procedure. During surgery, the ventricular Leadless Pacemaker (LP) was found in ROM mode. The LP was removed and a different LP was used to complete the procedure. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871790 ↗
• MalfunctionSep 23, 2026Failure to Interrogate

  It was reported that conductive telemetry could not be established with the ventricular leadless pacemaker (vLP) during an initial implant procedure on (b)(6) 2026. Troubleshooting measures were attempted but all were ultimately unsuccessful. The vLP was not used and a new vLP was implanted. The patient was stable throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867979 ↗
• MalfunctionSep 18, 2026Stretched; Use of Device Problem; Low impedance; Capturing Problem

  During an initial implant of a ventricular leadless pacemaker (vLP) on (b)(6)2026, it was reported that the vLP was repositioned multiple times due to unsatisfactory impedance, current of injury, and capture threshold parameters. A chest X-Ray then revealed the helix of the vLP was stretched. The vLP was not used and a new vLP was successfully implanted. The patient was stable throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819117 ↗
• MalfunctionSep 17, 2026High impedance; Stretched

  It was reported that the patient presented in clinic for Aveir leadless pacemaker (LP) implant procedure. During implant, it was observed that the LP exhibited high impedance and was repositioned. Upon repositioning, the helix of the LP was noted to become stretched. The procedure was completed using an alternate LP on 29 AUG 2026. The patient's status was unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50806172 ↗
• MalfunctionSep 17, 2026Stretched; Use of Device Problem; Low impedance

  It was reported that the patient presented in clinic for initial implant procedure on (b)(6) 2026. Post fixation during procedure, the right ventricular (RV) leadless pacemaker (LP) exhibited no increase in pacing impedance and little to none current of injury. Repositioning was attempted, and the RVLP helix was noted to be sprung under fluoroscopy imaging. The RVLP was not implanted, and an alternate RVLP was implanted instead. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797300 ↗
• InjurySep 16, 2026Capturing Problem

  It was reported that an increase in capture threshold was observed on the right ventricular (RV) leadless pacemaker (LP) resulting in patient experiencing syncope. The RV LP is pending a replacement procedure. The patient was stable.

  Patient problems: Syncope/Fainting

  MAUDE report 50792874 ↗
• MalfunctionSep 15, 2026Premature Discharge of Battery

  It was reported that the patient presented for a follow-up in clinic. Interrogation of the ventricular leadless pacemaker (vLP) revealed the battery's longevity had prematurely depleted. The patient was asymptomatic. No intervention was performed and there were no consequences to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774239 ↗
• MalfunctionSep 14, 2026Stretched; Device Dislodged or Dislocated

  Patient problems: Embolism/Embolus

  MAUDE report 50764141 ↗
• MalfunctionSep 14, 2026Device Dislodged or Dislocated

  It was reported that the patient's Aveir leadless pacemaker (LP) dislodged during implant procedure. The LP was retrieved without any noted complications. The patient was stable.

  Patient problems: Embolism/Embolus

  MAUDE report 50756307 ↗
• MalfunctionSep 8, 2026Stretched; Use of Device Problem; Impedance Problem

  During an initial implant procedure, low current of injury (COI) and varying low impedance values were observed on the leadless pacemaker (LP). The LP was repositioned and the helix became stretched after interacting with a valve. The LP was explanted and replaced to resolve the event. The patient is stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50660192 ↗
• MalfunctionSep 4, 2026Stretched

  It was reported that during the implant of a right ventricle leadless pacemaker (RVLP) that during repositioning the RVLP became entangled within the trabeculae. During retrieval and repositioning attempt, the helix was noted to have sprung. The RVLP was not implanted. The patient condition was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50611585 ↗
• MalfunctionSep 4, 2026Stretched

  During initial implant procedure, the helix of the leadless pacemaker (LP) stretched during placement. The leadless pacemaker was explanted. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50611113 ↗
• MalfunctionSep 4, 2026Stretched

  During initial implant, the helix of the leadless pacemaker (LP) appeared to be stretched after an attempt to reposition. The LP was explanted and replaced to resolve event. The patient was stable with no consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50601553 ↗
• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient presented remotely via Merlin.net with an alert of polarity switch due to high pacing impedance on the atrial lead. The atrial lead also exhibited oversensing noise, high capture threshold, undersensing, and poor sensing. Atrial sensitivity was reprogrammed to 0.5mV at the time of check. Additionally, there was also mention of pacemaker lead infection. No further changes or interventions were reported. The patient condition was not reported.

  Patient problems: Unspecified Infection

  MAUDE report 50595891 ↗
• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that in the days following implant of the leadless pacemaker (LP), the patient developed a cardiac tamponade. A small lesion was present in the right ventricle which was considered to be the source of the tamponade. The lesion was not located at the LP implantation site. Additionally, there was a small pericardial effusion in a location that was not in close proximity to the LP. The tamponade was surgically drained and the patient was stable.

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 50587670 ↗
• MalfunctionSep 2, 2026Capturing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50576835 ↗
• MalfunctionSep 1, 2026Stretched

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50542131 ↗

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