Aveir™ LSL02Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 05415067031914), received between Jun 1, 2022 and Apr 21, 2025 — classified as 2 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (27 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A CAPTURE THRESHOLD TEST AS THE CAPTURE THRESHOLD WAS DECREMENTING, THE PATIENT EXPRESSED THEY WERE FELLING STRANGE. LOSS OF CAPTURE OCCURRED; HOWEVER IT WAS NOT VISIBLE ON THE ELECTROGRAM (EGM). THE CAPTURE THRESHOLD WAS RECORDED SO NO INTERVENTION WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Discomfort

  MAUDE report 21877991 ↗
• MalfunctionMar 13, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT LOSS OF CAPTURE WAS OBSERVED ON THE ATRIAL LEADLESS DEVICE. A CAPTURE THRESHOLD TEST WAS PERFORMED AFTER THE OUTPUT OF THE DEVICE WAS REPROGRAMMED AND CAPTURE WAS OBSERVED ON THE TEST. HOWEVER, WHEN COMPARING THE CAPTURE THRESHOLD TEST TO AN EXTERNAL ELECTROCARDIOGRAM, THERE WAS NO CAPTURE VISIBLE. THE PATIENT IS DEPENDENT ON ATRIAL PACING, BUT DID NOT EXPERIENCE ANY SYMPTOMS OR CONSEQUENCES DUE TO THE EVENT. THE SYSTEM WAS REPROGRAMMED TO VENTRICULAR PACING ONLY TO RESOLVE THE EVENT, AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21599313 ↗
• MalfunctionDec 10, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT LOSS OF CAPTURE WASN'T ABLE TO BE OBSERVED DURING A CAPTURE THRESHOLD TEST. AS A RESULT, THE PATIENT EXPERIENCED ARRHYTHMIA AND DIZZINESS. THE CAPTURE TEST WAS TERMINATED TO RESOLVE THE EVENT, AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Arrhythmia; Dizziness

  MAUDE report 20896339 ↗
• MalfunctionMay 15, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP WITH SHORTNESS OF BREATH, NAUSEA, AND LIGHT HEADEDNESS. UPON INTERROGATION, THE LINK MODULE EXHIBITED ARTIFACTS DURING CAPTURE THRESHOLD TESTING. IT WAS DETERMINED THE LEADLESS PACEMAKER (LP) EXHIBITED HIGH CAPTURE THRESHOLDS POTENTIALLY CAUSED BY A MICRODISLODGEMENT FOUND THROUGH CHEST X-RAYS. PROGRAMMING CHANGES WERE IMPLEMENTED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19327025 ↗
• InjuryNov 30, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE ELECTROCARDIOGRAM (ECG) TRANSMITTED BY THE PROGRAMMER LINK DID NOT DISPLAY THE LOSS OF CAPTURE THAT OCCURRED DURING A CAPTURE THRESHOLD TEST. THE PATIENT IS PACER-DEPENDENT AND SUBSEQUENTLY, THE PATIENT EXPERIENCED DIZZINESS. THE PHYSICIAN PERFORMED THE TEST AGAIN WITH AN EXTERNAL ECG CABLE AND SUCCESSFULLY IDENTIFIED WHEN LOSS OF CAPTURE OCCURRED. NO ADDITIONAL INTERVENTION WAS PERFORMED TO RESOLVE THE EVENT AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Dizziness

  MAUDE report 18241210 ↗
• MalfunctionNov 22, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PATIENT PRESENTED AT A FOLLOW-UP IN CLINIC. DURING INTERROGATION, WHEN LOSS OF CAPTURE WAS INDUCED BY THE LEADLESS PACEMAKER, IT WAS UNABLE TO BE DETERMINED DUE TO THE LINK MODULE ELECTROCARDIOGRAM ANOMALY. A SECONDARY ELECTROCARDIOGRAM REVEALED THE LOSS OF CAPTURE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18193874 ↗
• MalfunctionSep 29, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT PRESENTED FOR A IN-CLINIC FOLLOW UP. A CAPTURE THRESHOLD TEST WAS PERFORMED, AND NO LOSS OF CAPTURE WAS OBSERVED ON THE ELECTROCARDIOGRAM TRANSMITTED FROM THE LINK MODULE. THIS LED TO A PACING PAUSE LONGER THAN DESIRED RESULTING IN THE PATIENT EXPERIENCING LOSS OF BREATH AND DIZZINESS. THE TEST WAS CONCLUDED, AND NORMAL DEVICE FUNCTION RESUMED. THE PATIENT WAS STABLE.

  Patient problems: Dizziness; Dyspnea

  MAUDE report 17848260 ↗
• MalfunctionSep 18, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT PRESENTED FOR AN IN-CLINIC DEVICE CHECK. A CAPTURE THRESHOLD TEST WAS PERFORMED, AND NO LOSS OF CAPTURE WAS OBSERVED ON THE ELECTROCARDIOGRAM TRANSMITTED FROM THE LINK MODULE. THIS RESULTED IN A PACING PAUSE LONGER THAN DESIRED AND THE PATIENT REPORTED FEELING DIZZY. THE THRESHOLD TEST WAS CONCLUDED, AND NORMAL PACING FUNCTION RESUMED. THE PATIENT WAS STABLE.

  Patient problems: Dizziness

  MAUDE report 17769806 ↗
• MalfunctionJul 13, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. DURING IMPLANT, A CAPTURE THRESHOLD TEST WAS PERFORMED AND NO LOSS OF CAPTURE WAS OBSERVED ON THE ELECTROCARDIOGRAM TRANSMITTED FROM THE LINK MODULE. THIS RESULTED IN A PACING PAUSE LONGER THAN DESIRED AS THE PATIENT WAS DEPENDENT. PACING RESUMED APPROPRIATELY FOLLOWING THE TEST COMPLETION. THE PATIENT WAS STABLE.

  Patient problems: Arrhythmia

  MAUDE report 17318212 ↗
• MalfunctionApr 6, 2023Signal Artifact/Noise; Incorrect, Inadequate or Imprecise Result or Readings; Signal Artifact/Noise; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A LEADLESS PACEMAKER IMPLANT PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THERE WAS NOISE ON THE ELECTROCARDIOGRAM (ECG) DUE TO THE LINK MODULE. THIS LED TO AN INABILITY TO VERIFY LOSS OF CAPTURE DURING CAPTURE THRESHOLD TESTING. ULTRASOUND GEL WAS APPLIED AND NEW ELECTRODES WERE USED WHICH HELP REDUCE THE NOISE BUT DID NOT ELIMINATE IT. AN EXTERNAL DEFIBRILLATOR WAS USED TO VERIFY LOSS OF CAPTURE. NO ADDITIONAL INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16687623 ↗
• MalfunctionMar 13, 2023Signal Artifact/Noise; Incorrect, Inadequate or Imprecise Result or Readings; Signal Artifact/Noise; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A LEADLESS PACEMAKER IMPLANT PROCEDURE. PRIOR TO PROCEDURE, NOISE WAS NOTED ON THE PROGRAMMER LINK MODULE DUE TO ELECTROMAGNETIC INTERFERENCE. THE PHYSICIAN DISCONNECTED THE ANESTHESIA ELECTROCARDIOGRAM (ECG) AND THE NOISE DECREASED. DURING THE CAPTURE THRESHOLD TEST DURING PROCEDURE, LOSS OF CAPTURE WAS NOT INDICATED AND AN EXTERNAL ECG WAS NEEDED FOR VISUALIZATION. THE IMPLANT PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16530411 ↗
• MalfunctionFeb 21, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT PRESENTED IN CLINIC FOR THE IMPLANT PROCEDURE. DURING IMPLANT, IT WAS OBSERVED THE AVEIR LINK FAILED TO SHOW LOSS OF CAPTURE ON THE ELECTROCARDIOGRAM. THE PATIENT WAS NOT DEPENDENT AND DID NOT EXPERIENCE SYMPTOMS. THE PROCEDURE COMPLETED WITHOUT ANY FURTHER ISSUE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16414674 ↗
• MalfunctionNov 21, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP. DURING CAPTURE THRESHOLD TESTING, IT WAS OBSERVED THE AVEIR PROGRAMMER LINK MODULE ELECTROCARDIOGRAPHY MORPHOLOGY DISPLAY DID NOT CHANGE WHEN LOSS OF CAPTURE WAS REACHED. THE CAPTURE THRESHOLD TEST WAS TERMINATED. NO INTERVENTION WAS REQUIRED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15838870 ↗
• MalfunctionNov 21, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A LEADLESS PACEMAKER POST-OPERATION DEVICE CHECK. CAPTURE THRESHOLD TESTING WAS THEN PERFORMED. DURING THE CAPTURE THRESHOLD TEST, IT WAS FOUND THAT THE PATIENT EXHIBITED DISCOMFORT AS THE THRESHOLD DECREASED, BUT THERE WAS NO INDICATION OF LOSS OF CAPTURE ON THE ELECTROCARDIOGRAM (ECG). IT WAS DETERMINED THAT THIS WAS INDICATIVE OF AN ECG ANOMALY ON THE LINK MODULE. THE THRESHOLD TEST WAS ENDED AND THE ISSUE WAS RESOLVED. NO FURTHER INTERVENTION WAS PERFORMED. THE PATIENT WAS DISCHARGED.

  Patient problems: Discomfort

  MAUDE report 15833518 ↗
• MalfunctionNov 18, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE ELECTROCARDIOGRAM (ECG) TRANSMITTED BY THE PROGRAMMER LINK DID NOT DISPLAY THE LOSS OF CAPTURE THAT OCCURRED DURING A CAPTURE THRESHOLD TEST. THE THRESHOLD TEST WAS ENDED AND NO PATIENT CONSEQUENCE WAS OBSERVED. NO INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15822171 ↗
• MalfunctionNov 17, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE ELECTROCARDIOGRAM (ECG) TRANSMITTED BY THE PROGRAMMER LINK DID NOT DISPLAY THE LOSS OF CAPTURE THAT OCCURRED DURING A CAPTURE THRESHOLD TEST. THE THRESHOLD TEST WAS ENDED AND NO PATIENT CONSEQUENCE WAS OBSERVED. NO INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15819936 ↗
• MalfunctionNov 17, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE ELECTROCARDIOGRAM (ECG) TRANSMITTED BY THE PROGRAMMER LINK DID NOT DISPLAY THE LOSS OF CAPTURE THAT OCCURRED DURING A CAPTURE THRESHOLD TEST. THE THRESHOLD TEST WAS ENDED AND NO PATIENT CONSEQUENCE WAS OBSERVED. NO INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15819876 ↗
• MalfunctionNov 17, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE ELECTROCARDIOGRAM (ECG) TRANSMITTED BY THE PROGRAMMER LINK DID NOT DISPLAY THE LOSS OF CAPTURE THAT OCCURRED DURING A CAPTURE THRESHOLD TEST. THE THRESHOLD TEST WAS ENDED AND NO PATIENT CONSEQUENCE WAS OBSERVED. NO INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15819707 ↗
• MalfunctionNov 17, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE ELECTROCARDIOGRAM (ECG) TRANSMITTED BY THE PROGRAMMER LINK DID NOT DISPLAY THE LOSS OF CAPTURE THAT OCCURRED DURING A CAPTURE THRESHOLD TEST. THE THRESHOLD TEST WAS ENDED AND NO PATIENT CONSEQUENCE WAS OBSERVED. NO INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15818753 ↗
• MalfunctionNov 17, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE ELECTROCARDIOGRAM (ECG) TRANSMITTED BY THE PROGRAMMER LINK DID NOT DISPLAY THE LOSS OF CAPTURE THAT OCCURRED DURING A CAPTURE THRESHOLD TEST. THE THRESHOLD TEST WAS ENDED AND NO PATIENT CONSEQUENCE WAS OBSERVED. NO INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15818521 ↗
• MalfunctionNov 17, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE ELECTROCARDIOGRAM (ECG) TRANSMITTED BY THE PROGRAMMER LINK DID NOT DISPLAY THE LOSS OF CAPTURE THAT OCCURRED DURING A CAPTURE THRESHOLD TEST. THE THRESHOLD TEST WAS ENDED AND NO PATIENT CONSEQUENCE WAS OBSERVED. NO INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15818270 ↗
• MalfunctionNov 17, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE ELECTROCARDIOGRAM (ECG) TRANSMITTED BY THE PROGRAMMER LINK DID NOT DISPLAY THE LOSS OF CAPTURE THAT OCCURRED DURING A CAPTURE THRESHOLD TEST. THE THRESHOLD TEST WAS ENDED AND NO PATIENT CONSEQUENCE WAS OBSERVED. NO INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15815980 ↗
• MalfunctionNov 7, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PATIENT PRESENTED DURING CLINICAL FOLLOW-UP. DURING INTERROGATION, IT WAS NOTED THAT THE AVEIR LINK EXHIBITED AN ELECTROCARDIOGRAM ANOMALY WHICH CAUSED A CAPTURING DISCREPANCY RESULTING IN PATIENT SYMPTOMS OF ARRHYTHMIA AND DIZZINESS. NO INTERVENTIONS WERE PERFORMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Arrhythmia; Dizziness

  MAUDE report 15749810 ↗
• MalfunctionOct 25, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT PRESENTED IN CLINIC. DURING CAPTURE THRESHOLD TESTING, IT WAS OBSERVED THE LINK MODULE FAILED TO SHOW LOSS OF CAPTURE LEADING TO A TEN SECOND ASYSTOLIC EPISODE. THE LOSS OF CAPTURE WAS OBSERVED ON THE TELEMETRY STRIP AT THE NURSE'S DESK, AS THE PATIENT WAS NOT HOOKED UP TO BED SIDE TELEMETRY. NO INTERVENTION WAS COMPLETED. THE PATIENT WAS STABLE.

  Patient problems: Arrhythmia

  MAUDE report 15667226 ↗
• MalfunctionOct 7, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A PRE-DISCHARGE CHECK. DURING THE CAPTURE THRESHOLD TEST, AN ECG (ELECTROCARDIOGRAM) ANOMALY WAS NOTED DUE TO THE LINK MODULE AND THE PATIENT EXPERIENCED LOSS OF CAPTURE AND ASYSTOLE. NO FURTHER INTERVENTION WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Arrhythmia

  MAUDE report 15567992 ↗

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