UltiPace™ LPA1231 (UDI 05415067046314)Recalls & reported problems

Summary

The FDA's MAUDE database contains 952 adverse event reports that list this exact device (DI 05415067046314), received between Nov 14, 2023 and Sep 30, 2026 — classified as 19 deaths, 702 injuries, 231 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (430 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 952 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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, 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 ↗
• 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 50942547 ↗
• 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 ↗
• MalfunctionSep 29, 2026Difficult to Fold, Unfold or Collapse; Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941075 ↗
• InjurySep 29, 2026Device Dislodged or Dislocated

  It was reported that the atrial lead was dislodged. Hence, the atrial lead was explanted and replaced on (b)(6) 2026. The patient was stable throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928725 ↗
• MalfunctionSep 29, 2026High impedance; Over-Sensing; Capturing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928519 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented in the clinic with an infection at the implanted device pocket site. The physician explanted the entire system ¿ pacemaker, right ventricular lead and atrial lead due to infection. The patient was in stable condition throughout the procedure.

  Patient problems: Unspecified Infection

  MAUDE report 50927976 ↗
• InjurySep 29, 2026Failure to Capture; Failure to Sense; 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 had dislodged and exhibited failure to capture and failure to sense. The dislodgement of the lead was verified by fluoroscopy. The RA lead was explanted and replaced. The patient was in stable condition throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927903 ↗
• InjurySep 28, 2026Failure to Sense; Capturing Problem; Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926694 ↗
• MalfunctionSep 28, 2026Over-Sensing; Under-Sensing

  It was reported that a patient presented remotely via Merlin.net. Review of the transmission revealed oversensing noise on the atrial lead. The patient has previous history of atrial fibrillation undersensing which was addressed by reprogramming to the most sensitive setting. Programming changes were performed to address the oversensing noise issue. The patient has been asymptomatic throughout.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918218 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient's pacemaker, right atrial (RA) lead and right ventricular (RV) lead were explanted and replaced with a dual chamber leadless pacemaker due to endocarditis and aortic valve vegetation. The patient condition was not known.

  Patient problems: Unspecified Infection

  MAUDE report 50911123 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented with a visually identified pocket infection. The reported infection was determined to be unrelated to any Abbott product. However, the relationship between the infection and the procedure could not be established. As a result, the pacemaker (PM), the right ventricle (RV) and atrial leads were explanted. New leadless pacemaker systems were subsequently implanted. The cause of the infection was unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50910885 ↗
• InjurySep 28, 2026Difficult to Fold, Unfold or Collapse; Device Dislodged or Dislocated

  It was reported that the patient presented to hospital for an implant procedure. Post procedure, it was noted that the right atrial (RA) lead had dislodged, and programming changes were performed to VVI mode. During the repositioning procedure, it was noted that the RA lead failed to extend the helix. The RA lead dislodgement was confirmed through chest X-ray. The RA lead was explanted and replaced. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910646 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the hospital with infection and was tested positive for bacteremia. The physician stated that the infection was not caused by Abbotts' devices. The patient's implantable cardioverter-defibrillator, the right atrial lead, the right ventricular lead and the left ventricular lead were explanted due to the infection. The patient was stable throughout.

  Patient problems: Unspecified Infection

  MAUDE report 50910622 ↗
• InjurySep 28, 2026Failure to Capture; Over-Sensing

  Patient problems: Insufficient Information

  MAUDE report 50910501 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented with an infection at the device site. The cause of the infection was unclear. There was no erosion of the device and leads and no vegetation was found on the leads. The gallant, right atrial lead, right ventricular lead and left ventricular lead were explanted. The patient was in stable condition throughout the procedure.

  Patient problems: Unspecified Infection

  MAUDE report 50894227 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the hospital with drainage at the device implant site due to infection. The patient's implantable cardioverter-defibrillator, the right atrial lead and the right ventricular lead were explanted due to the infection. The patient was stable throughout.

  Patient problems: Unspecified Infection

  MAUDE report 50893294 ↗
• MalfunctionSep 24, 2026Device Dislodged or Dislocated

  It was reported that the patient presented to the clinic for a scheduled follow-up. Upon interrogation, the right atrial (RA) lead was found to be dislodged. No intervention was reported. The patient experienced no adverse consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50879927 ↗
• InjurySep 24, 2026Signal Artifact/Noise; Device 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 50876693 ↗
• InjurySep 23, 2026Difficult to Fold, Unfold or Collapse; Therapy Delivered to Incorrect Body Area; Detachment of Device or Device Component; Device Dislodged or Dislocated

  It was reported that the patient experienced dizziness, low blood pressure, and vomiting associated with stimulation of the vagus nerve. Diagnostic imaging was performed and dislodgment of the right atrial (RA) lead was observed. A revision procedure was performed and repositioning of the RA lead was attempted, however, difficulty extending and retracting the helix was noted. The RA lead was explanted and a piece of the RA lead detached outside of the body of the patient. The RA lead was replaced. The patient was in stable condition.

  Patient problems: Dizziness; Low Blood Pressure/ Hypotension; Vomiting

  MAUDE report 50869722 ↗
• InjurySep 23, 2026Failure to Capture; Device Dislodged or Dislocated

  It was reported that the patient presented in clinic for a follow-up. Upon interrogation, the right ventricle lead exhibited failure to capture. Further evaluation with X-ray imaging revealed lead dislodgement. The lead was explanted and replaced. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869381 ↗
• MalfunctionSep 23, 2026Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867673 ↗