UltiPaceRecalls & reported problems across all models

We found 4 models of UltiPace by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 2,739 adverse event reports in the FDA's MAUDE database, received between Oct 25, 2023 and Sep 30, 2026 — classified as 37 deaths, 1,646 injuries, 1,055 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1,021 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported UltiPace problems

UltiPace models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• UltiPace™ LPA1231

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  19 deaths952 reports
• UltiPace™ LPA1231

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  7 deaths849 reports
• UltiPace™ LPA1231

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  8 deaths657 reports
• UltiPace™ LPA1231

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  3 deaths281 reports

Recent UltiPace adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break; Difficult to Fold, Unfold or Collapse; Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954925 ↗
• InjurySep 30, 2026Failure to Capture; Device Dislodged or Dislocated

  It was reported that the patient experienced palpitations and was brought to the Emergency room. Upon device interrogation, loss of capture was noted on the Right atrial lead. Lead dislodgement was confirmed via chest x-ray imaging. The lead was explanted and replaced with another lead. The patient was stable.

  Patient problems: Arrhythmia

  MAUDE report 50952804 ↗
• 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 50952392 ↗
• 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, 2026Difficult to Fold, Unfold or Collapse; Capturing Problem

  It was reported that a stable inpatient was brought to electrophysiology lab for a lead revision. Prior to the procedure, it was confirmed via chest X-ray imaging that there was right atrial (RA) lead dislodgment with elevated capture thresholds. It was also observed that the right ventricular lead exhibited sensing and pacing anomalies. During the lead revision, the helix deployment of both leads was suspected to be inadequate. The leads were ultimately explanted, and replacement leads were implanted. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950926 ↗
• InjurySep 30, 2026Over-Sensing; Device Dislodged or Dislocated

  It was reported that the patient presented to the hospital following an implant procedure. Upon device interrogation, the right atrial (RA) lead exhibited far-field P-wave oversensing. Chest X-ray imaging revealed the RA lead dislodgement into the right ventricle. The RA lead was explanted and replaced. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944806 ↗
• MalfunctionSep 30, 2026Difficult to Fold, Unfold or Collapse

  It was reported that the patient presented to the hospital for a scheduled implant procedure. During the procedure, the right ventricular (RV) lead exhibited a helix mechanism issue, resulting in the inability to extend the helix. The RV lead was subsequently removed and replaced. The patient's condition was not reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943101 ↗
• InjurySep 30, 2026Device Dislodged or Dislocated

  It was reported that the patient presented to the clinic for a scheduled follow-up visit. Upon interrogation, the patient's right ventricular (RV) lead was found to be dislodged. The RV lead was subsequently explanted and replaced on (b)(6) 2026. No adverse patient consequences were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943061 ↗
• 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 30, 2026Failure to Capture; Over-Sensing; Device Dislodged or Dislocated

  It was reported that the patient presented for a pacemaker implantation procedure. During the procedure, it was noted that the right atrial (RA) lead dislodged, which was confirmed via fluoroscopy. The RA lead was repositioned. On the following day, device interrogation revealed that the RA lead exhibited failure to capture and far R-wave oversensing. Fluoroscopy confirmed that the RA lead had dislodged again. The physician opted to explant and replace the RA lead. The patient remained in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942571 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the hospital with infection at device pocket. The vegetation was confirmed by transesophageal echocardiogram (TTE). The pacemaker, right atrial (RA) lead and right ventricular (RV) lead were explanted and replaced. The patient was in stable condition throughout the procedure.

  Patient problems: Unspecified Infection

  MAUDE report 50942550 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the hospital with infection at device pocket. The vegetation was confirmed by transesophageal echocardiogram (TTE). The pacemaker, right atrial (RA) lead and right ventricular (RV) lead were explanted and replaced. The patient was in stable condition throughout the procedure.

  Patient problems: Unspecified Infection

  MAUDE report 50942547 ↗
• InjurySep 30, 2026Failure to Capture; Use of Device Problem; Device Dislodged or Dislocated

  It was reported that the patient presented to the hospital following an implant procedure. Upon device interrogation, the right ventricular (RV) lead exhibited loss of capture. Chest X-ray and fluoroscopy imaging revealed lack of slack in the RV lead, resulting in lead dislodgement. The RV lead was explanted and replaced. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942354 ↗
• MalfunctionSep 30, 2026Signal Artifact/Noise

  It was reported that the patient presented for a scheduled implant procedure. During the procedure, the right atrial (RA) lead exhibited noise. The RA lead was not used and replaced. The patient was in a stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941850 ↗

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