Aveir™ LSN25301Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067034823), received between Dec 22, 2025 and Sep 10, 2026 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during an Aveir DR implant procedure on a congenital patient, the physician elected to start the procedure with the right atrium leadless pacemaker (RALP). The RALP was released at the target location. When attempting to manipulate the right ventricle leadless pacemaker (RVLP) with the delivery catheter into the RV, the catheter mechanically dislodged the fixed RALP. The RALP embolized in the left femoral artery. The physician inserted an introducer and retrieval catheter into the patient's right femoral artery and snared the RALP. The RALP was pulled toward the introducer but met resistance in the right femoral artery. Under fluoroscopy, contrast arteriograms showed a laceration in the right femoral artery between the introducer and the RALP. Vascular surgery was initiated to retrieve the RALP and repair the vessel. The patient was stable throughout the surgery and is recovering.

  Patient problems: Vascular Dissection

  MAUDE report 50722109 ↗
• DeathDec 22, 2025Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT OF A RIGHT VENTRICLE LEADLESS PACEMAKER (RVLP) THAT THE PHYSICIAN WAS UNABLE TO CROSS THE TRICUSPID VALVE DUE TO TORTUOUS ANATOMY. THE PHYSICIAN ELECTED TO ATTEMPT IMPLANT THROUGH THE RIGHT INTERNAL JUGULAR VEIN. THE DEVICE WAS ADVANCED IN THE RIGHT VENTRICLE AND POSITIONED IN THE AREA OF THE RIGHT VENTRICLE SEPTUM, MAPPING WAS PERFORMED AND THE RVLP WAS NOT CAPTURING AT 5V. THE RVLP WAS REPOSITIONED TO A DIFFERENT AREA, AND AROUND THIS TIME THEY COULD NOT MEASURE THE PATIENT'S BLOOD PRESSURE. THE RVLP, CATHETER, AND INTRODUCER WERE REMOVED AND CPR WAS COMMENCED BUT THE PATIENT COULD NOT BE REVIVED. THE PHYSICIAN SUSPECTS CARDIAC PERFORATION.

  Patient problems: Arrhythmia; Cardiac Perforation; Low Blood Pressure/ Hypotension

  MAUDE report 23863953 ↗