UltiPace™ LPA1231 (UDI 05415067046345)Recalls & reported problems

Summary

The FDA's MAUDE database contains 281 adverse event reports that list this exact device (DI 05415067046345), received between Oct 25, 2023 and Sep 30, 2026 — classified as 3 deaths, 227 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (135 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 281 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Signal Artifact/Noise; Fracture; High impedance; Use of Device Problem; Device Dislodged or Dislocated

  It was reported that the patient exhibited Twiddler¿s syndrome causing migration of the pacemaker and dislodgement of the Right Atrial (RA) and Right Ventricular (RV) leads. The dislodgement resulted in diaphragmatic stimulation and patient discomfort. Programming changes were made to address the issue. On (b)(6) 2026, during the procedure, the physician explanted the Right Atrial (RA) lead. A replacement RA lead was installed; however, the lead became dislodged and exhibited noise, high impedance, and low current of injury. RA lead fracture was suspected. This RA lead was not used, and the physician completed the procedure using a different RA lead replacement. Additionally, the RV lead was explanted and replaced during the procedure. The patient was discharged, same day, following the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952393 ↗
• InjurySep 30, 2026Therapy Delivered to Incorrect Body Area; Device Dislodged or Dislocated

  It was reported that the patient exhibited Twiddler¿s syndrome causing migration of the pacemaker and dislodgement of the Right Atrial (RA) and Right Ventricular (RV) leads. The dislodgement resulted in diaphragmatic stimulation and patient discomfort. Programming changes were made to address the issue. On (b)(6) 2026, during the procedure, the physician explanted the Right Atrial (RA) lead. A replacement RA lead was installed; however, the lead became dislodged and exhibited noise, high impedance, and low current of injury. RA lead fracture was suspected. This RA lead was not used, and the physician completed the procedure using a different RA lead replacement. Additionally, the RV lead was explanted and replaced during the procedure. The patient was discharged, same day, following the procedure.

  Patient problems: Discomfort

  MAUDE report 50952386 ↗
• InjurySep 30, 2026Capturing Problem

  It was reported that the patient was admitted to the hospital for other reasons. Interrogation revealed that the right atrial (RA) lead exhibited high capture threshold. The RA lead was explanted and replaced. The patient remained stable throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942628 ↗
• InjurySep 24, 2026Device Sensing Problem

  It was reported that the patient¿s right atrial (RA) lead exhibited low sensing, while the right ventricular (RV) lead exhibited noise and low sensing. During the procedure, it was noted that the set screw of the pacemaker could not be loosened from the RA lead. The pacemaker, RA lead, and RV lead were explanted and replaced. The patient's condition was not known.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876684 ↗
• MalfunctionSep 16, 2026Over-Sensing; Pacing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797001 ↗
• InjurySep 16, 2026Capturing Problem; Device Dislodged or Dislocated

  It was reported that the patient presented remotely via Merlin.net. It was noted that the right atrial (RA) lead had dislodged, resulting in occasional right ventricular capture during atrial pacing, as observed on the Merlin transmission. The lead dislodgement was confirmed by chest X-ray and fluoroscopy during the lead revision procedure. The lead was explanted and replaced. The patient was discharged.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50783952 ↗
• InjurySep 15, 2026Insufficient Device Problem Information

  It was reported that the lead was explanted on (b)(6) 2026 due to unknown malfunction. No patient symptoms were reported.

  Patient problems: Insufficient Information

  MAUDE report 50767216 ↗
• InjurySep 15, 2026Intermittent Capture; Use of Device Problem

  It was reported that a patient presented with intermittent capture noted on the patient's system. The system was removed. However, an operation issue was noted on the right atrial lead. The system was explanted on (b)(6)2026. No adverse patient consequences were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766227 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient had infection. The patient's pacemaker, the right atrial (RA) lead and the right ventricular (RV) leads were explanted due to the infection. The patient's status was not provided.

  Patient problems: Unspecified Infection

  MAUDE report 50749008 ↗
• InjurySep 14, 2026Failure to Capture; Device Dislodged or Dislocated

  It was reported that the patient presented for an explant procedure. Prior to the procedure, it was noted that the right atrial (RA) lead and right ventricular (RV) lead had dislodged and exhibited failure to capture. The dislodgement of the lead was verified by X-ray. The RA and RV leads were explanted and replaced. The patient was in stable condition throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50748098 ↗
• InjurySep 11, 2026Failure to Capture; Failure to Sense; Device Dislodged or Dislocated

  It was reported that the patient experienced a fall involving the left arm. Fluoroscopic evaluation confirmed atrial lead dislodgement. Additionally, the atrial lead demonstrated loss of sensing and loss of capture. The atrial lead was subsequently explanted and replaced with a new lead. The patient was stable throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50727145 ↗
• InjurySep 9, 2026Failure to Capture; Under-Sensing; Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50701585 ↗
• InjurySep 9, 2026Capturing Problem; Device Dislodged or Dislocated

  It was reported that the patient experienced dyspnea. On, (b)(6) 2026, the physician suspected that the Right Atrial (RA) had dislodged based on an electrocardiogram (EKG) observation. Device interrogation was performed, and the RA lead exhibited high capture threshold. On (b)(6) 2026, an X-Ray was performed, and the RA lead appeared to be in the same location. Programming changes were performed to address the issue. An echocardiogram was performed that same day, and micro perforation of the heart was noted due to the RA lead. The physician explanted the RA lead. The patient was discharged from the hospital after the procedure.

  Patient problems: Cardiac Perforation; Dyspnea

  MAUDE report 50696872 ↗
• MalfunctionSep 3, 2026Over-Sensing

  It was reported that the patient's Right Atrial (RA) lead exhibited far field R wave oversensing and morphology channel oversensing. No intervention was performed. The patient had no adverse consequences due to the event and continued to be monitored.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50590537 ↗
• MalfunctionSep 3, 2026Failure to Capture; Failure to Sense; Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50576859 ↗
• InjuryAug 31, 2026Therapy Delivered to Incorrect Body Area

  It was reported that the patient's Right Ventricular (RV) and Right Atrial (RA) leads perforated the patient's heart during initial lead implant. The RA and RV leads were both revised. Afterwards, the patient's RA and RV leads exhibited phrenic nerve stimulation causing the patient discomfort. Programming changes were made. The patient had no adverse consequences due to the event.

  Patient problems: Cardiac Perforation; Discomfort

  MAUDE report 50524647 ↗
• InjuryAug 28, 2026Failure to Capture; Difficult to Fold, Unfold or Collapse; Over-Sensing

  It was reported that the patient presented to the clinic for a lead revision procedure. Prior to the procedure, device interrogation revealed that the atrial lead was inappropriately sensing and exhibited loss of capture. During the procedure, while the physician attempted to reposition the atrial lead, the helix failed to extend. As a result, the atrial lead was explanted and replaced. The patient remained stable throughout the procedure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50492362 ↗
• MalfunctionAug 28, 2026Over-Sensing

  It was reported that the patient¿s right atrial lead exhibited noise oversensing. No intervention was performed. There were no adverse patient consequences reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50491257 ↗
• InjuryAug 27, 2026Device Dislodged or Dislocated; Insufficient Device Problem Information

  It was reported that the patient presented remotely via Merlin.net. Review of the transmission revealed an unspecified electrical anomaly that suggested the right atrial (RA) lead had dislodged. The patient was then scheduled for a lead revision procedure. Pre-procedure interrogation also revealed that right ventricular (RV) sensing decreased when the patient changed position from sitting to lying down. The RV lead capture threshold and pacing impedance measurements were reported to be stable. Both the RV and RA leads were explanted and replaced. The patient remained stable before, during and after the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50468694 ↗
• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient's Right Atrial (RA) and Right Ventricular (RV) leads perforated their heart. The RA and RV leads were explanted and replaced. The patient was stable throughout.

  Patient problems: Cardiac Perforation

  MAUDE report 50329741 ↗
• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the hospital due to a lead infection. The physician elected to explant the entire pacing system, including the pacemaker, right ventricular (RV) lead, and right atrial (RA) lead, on (b)(6)2026. No patient condition was reported.

  Patient problems: Unspecified Infection

  MAUDE report 50294761 ↗
• InjuryAug 18, 2026Failure to Capture; Device Dislodged or Dislocated

  It was reported that the patient presented for an explant procedure. Prior to the procedure, it was noted that the right atrial (RA) lead and right ventricular (RV) lead had dislodged and exhibited failure to capture. The dislodgement of the leads was verified by fluoroscopy. The RA and RV lead were explanted and replaced. The patient was in stable condition throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50291075 ↗
• InjuryAug 18, 2026Failure to Capture; Over-Sensing; Device Dislodged or Dislocated

  It was reported that the patient presented to hospital for an implant procedure. Post implant procedure, it was noted that the right atrial (RA) lead was dislodged resulting in no atrial capture and inappropriately sensing ventricular event. The RA lead dislodgement was confirmed with fluoroscopy. The RA lead was explanted and replaced. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50290665 ↗
• InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented in clinic due to discomfort and irritability from their pacemaker pocket. Visual examination discovered that the patient's pacemaker was visible through an eroded hole in their pocket that also emitted a yellow discharge. It was determined that the patient had an allergic reaction to their pacemaker and an infection from their pacemaker, Right Atrial (RA) lead, and Right Ventricular (RV) lead. Antibiotics were administered to the patient. The pacemaker was explanted and replaced. The RA and RV leads remained implanted. The patient was discharged under stable condition.

  Patient problems: Discomfort; Unspecified Infection

  MAUDE report 50240270 ↗
• MalfunctionAug 13, 2026Over-Sensing

  It was reported that the patient presented to hospital for an implant procedure. During the procedure, it was noted that the right ventricular (RV) lead exhibited oversensing noise. Troubleshooting was performed; the issue persisted. The RV lead was note used and replaced on 31 July 2026. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50231684 ↗