Aveir™ LSP202VRecalls & reported problems

Summary

The FDA's MAUDE database contains 1,214 adverse event reports that list this exact device (DI 05415067040725), received between Aug 11, 2023 and Sep 30, 2026 — classified as 39 deaths, 364 injuries, 811 malfunctions.

The most frequently reported specific device problem is “Stretched” (323 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,214 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952606 ↗
• MalfunctionSep 30, 2026Stretched; Material Twisted/Bent; Premature 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 50951000 ↗
• MalfunctionSep 30, 2026Stretched

  It was reported that the patient presented in clinic for Aveir leadless pacemaker (LP) implant. During implant, it was observed that the helix of the LP became stretched during mapping. The procedure was completed using an alternate LP on (b)(6)2026. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950435 ↗
• MalfunctionSep 30, 2026Stretched

  It was reported that the patient presented in clinic for Aveir leadless pacemaker (LP) implant procedure. During the implant, it was observed that the helix of the LP was stretched. 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 50950070 ↗
• MalfunctionSep 30, 2026Stretched; Use of Device Problem; Low impedance

  It was reported that the patient presented for an implant procedure. During the procedure, low pacing impedance and inadequate current of injury was observed after device fixation. Re-positioning was attempted; however, the device helix was sprung in the process. The device was not used, and a new one was implanted. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949037 ↗
• InjurySep 29, 2026High impedance; Capturing 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 50935626 ↗
• MalfunctionSep 29, 2026Separation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935398 ↗
• MalfunctionSep 29, 2026Device Dislodged or Dislocated

  It was reported that a right ventricular (RV) leadless pacemaker (LP) was implanted successfully. Physician then had difficulty inserting the right atrial (RA) LP through the delivery catheter. An x-ray revealed the RV LP had dislodged and traveled into the inferior vena cava, blocking the RA LP from advancing. The RV LP was retrieved and replaced. Patient was stable.

  Patient problems: Embolism/Embolus

  MAUDE report 50927054 ↗
• MalfunctionSep 29, 2026Failure to Capture; Low impedance; Device Dislodged or Dislocated; Material Twisted/Bent; Difficult or Delayed Separation

  It was reported that pacing impedance decreased after fixation of a right ventricular leadless pacemaker (LP) during implant. Device was left as-is and released because all other measurements. Following the device release, abnormal movement of the distal tip of the device was observed. The impedance subsequently decreased again, and the pacing threshold increased with loss of capture. LP had dislodged and was free floating in the right atrium. Physician suspected LP had dislodged because of separation difficulties earlier in the procedure. The device was retrieved and a bent helix was observed. The LP was replaced to complete the procedure. Patient had no consequences.

  Patient problems: Embolism/Embolus

  MAUDE report 50927011 ↗
• MalfunctionSep 28, 2026Use of Device Problem

  It was reported that during a right ventricular leadless pacemaker (RVLP) that the physician was unable to successfully cross the tricuspid valve despite all troubleshooting techniques. Fluoroscopy showed that the patient had a narrow RV inflow. The physician believes this was due to protective sleeve and anatomy interaction with the helix. The RVLP was discarded and the physician elected to implant a transvenous pacemaker. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916713 ↗
• MalfunctionSep 28, 2026Separation Failure

  It was reported that the ventricular leadless pacemaker (vLP) could not be release from the delivery catheter (DC) during an initial implant procedure on (b)(6)2026. 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 50915337 ↗
• InjurySep 26, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  Patient problems: Cardiac Tamponade; No Clinical Signs, Symptoms or Conditions; Pericardial Effusion

  MAUDE report 50906472 ↗
• InjurySep 25, 2026Intermittent Capture

  Patient problems: Insufficient Information

  MAUDE report 50905688 ↗
• InjurySep 25, 2026Failure to Capture; Failure to Sense; Device Dislodged or Dislocated

  Patient problems: Embolism/Embolus

  MAUDE report 50901235 ↗
• MalfunctionSep 25, 2026Stretched; Low impedance

  It was reported that during the implant of a right ventricle leadless pacemaker (RVLP) that after the first fixation attempt, the pacing impedance would not increase. The physician elected to reposition and when attempting at the second mapping location, it was noted that the RVLP was stretched. The physician exchanged the delivery catheter and the RVLP and completed the procedure with new products. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900897 ↗
• 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 50899633 ↗
• InjurySep 25, 2026Device Dislodged or Dislocated

  It was reported that the patient presented in clinic with low heart rate. It was discovered that the patient's leadless pacemaker (LP) dislodged and traveled to the pulmonary artery. The LP was explanted and replaced. The patient was stable.

  Patient problems: Arrhythmia; Embolism/Embolus

  MAUDE report 50898701 ↗
• MalfunctionSep 25, 2026Use of Device Problem; Low impedance

  It was reported that the patient presented for an initial implant procedure of a ventricular leadless pacemaker (vLP) on (b)(6) 2026. After several fixation attempts, it was noted the impedance and current of injury of the vLP consistently stayed low. 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 50897591 ↗
• MalfunctionSep 25, 2026Stretched

  It was reported that the helix of a ventricular leadless pacemaker (vLP) stretched while maneuvering the device during an initial implant procedure on (b)(6) 2026. The stretched helix of the vLP was confirmed via a chest X-Ray. 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 50897508 ↗
• 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 50892181 ↗
• MalfunctionSep 24, 2026Stretched

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890302 ↗
• MalfunctionSep 24, 2026Stretched

  It was reported the helix of a ventricular leadless pacemaker (vLP) stretched during an initial implant procedure on (b)(4) 2026. 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 50883390 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  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 50883327 ↗
• MalfunctionSep 24, 2026Stretched

  It was reported the helix of a ventricular leadless pacemaker (vLP) stretched during an initial implant procedure on (b)(6)2026. 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 50882916 ↗
• MalfunctionSep 23, 2026Device Dislodged or Dislocated

  Patient problems: Embolism/Embolus

  MAUDE report 50876288 ↗

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