UltiPace™ LPA1231 (UDI 05415067046338)Recalls & reported problems

Summary

The FDA's MAUDE database contains 657 adverse event reports that list this exact device (DI 05415067046338), received between Jan 3, 2024 and Sep 30, 2026 — classified as 8 deaths, 391 injuries, 258 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (217 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 657 reports, in the reporter's own words as published by the FDA.

• 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, 2026Failure to Capture

  It was reported that the patient presented to the clinic for a follow up. Interrogation of the pulse generator noted that the right ventricular (RV) lead had failed to capture. The lead was capped and replaced on (b)(6) 2026. The patient was stable throughout.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941845 ↗
• MalfunctionSep 29, 2026Difficult to Fold, Unfold or Collapse; Difficult to Insert

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936505 ↗
• MalfunctionSep 29, 2026Difficult to Fold, Unfold or Collapse; Difficult to Insert

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936502 ↗
• 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 50927978 ↗
• InjurySep 29, 2026Low impedance; Capturing Problem; Device Sensing Problem

  It was reported that the patient presented to the clinic. Upon device interrogation, the right ventricular (RV) lead exhibited a high capture threshold, low pacing impedance and increased R-wave amplitude variation. The patient reported discomfort during RV pacing. Based on the this, the physician elected to reposition the RV lead. The RV lead was repositioned on (b)(6)2026. The patient remained stable throughout the procedure, and no adverse patient consequences were reported.

  Patient problems: Discomfort

  MAUDE report 50927105 ↗
• 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 50911110 ↗
• 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 50910886 ↗
• InjurySep 24, 2026Failure to Capture; Device Dislodged or Dislocated

  It was reported that the patient presented to the clinic. Upon device interrogation, the right atrial (RA) lead exhibited loss of capture. Further evaluation revealed that the RA lead was dislodged, which was subsequently confirmed by X-ray. The patient was reprogrammed and referred for lead revision. As a result, the RA lead was explanted and replaced. The patient remained stable throughout the procedure, and no adverse patient consequences were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876830 ↗
• InjurySep 18, 2026Failure to Capture; Over-Sensing; Device Dislodged or Dislocated

  It was reported that following a new implant procedure, at the post operative follow up check, it was noted that the left bundle branch pacing (LBBP) exhibited no capture and wide QRS oversensing was observed on the right ventricular (RV) lead. A possible perforation of the RV lead into the left ventricle (LV) was suspected. A CT scan showed the RV lead had migrated/dislodged to the LV myocardium, but it had not penetrated into the LV blood pool. The RV lead was explanted and replaced. The patient was stable.

  Patient problems: Cardiac Perforation

  MAUDE report 50825390 ↗
• InjurySep 18, 2026Intermittent Capture; Device Dislodged or Dislocated

  It was reported that the patient presented to the hospital for an implant procedure. During the pre-discharge check, it was noted that the right ventricular (RV) lead exhibited intermittent capture at a high capture threshold and was dislodged. The RV lead dislodgement was confirmed by chest X-ray. The RV lead was explanted and replaced. The patient was discharged following the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50814183 ↗
• DeathSep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a remote transmission was received indicating a high ventricular rate episode, ventricular tachycardia with no termination and subsequent autopolarity switch on the pacemaker. The pacemaker does not deliver therapy for arrhythmias such as ventricular tachycardia. The clinician subsequently checked on the patient. It was found that the patient was deceased. There was no complaint of malfunction on the pacemaker/system by the physician.

  Patient problems: Arrhythmia

  MAUDE report 50804925 ↗
• MalfunctionSep 17, 2026Break

  It was reported that the patient presented to hospital for an implant procedure. During the procedure, it was noted that the helix of the low voltage lead was deformed. The low voltage lead was not used and replaced on (b)(6) 2026. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50798541 ↗
• 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 50766225 ↗
• MalfunctionSep 14, 2026Use of Device Problem

  It was reported that the patient presented to the hospital and experienced symptoms related to right ventricular (RV) lead pacing. The RV lead was explanted and replaced with a left bundle branch area (LBBA) lead. Multiple repositioning attempts were made on the LBBA lead. The LBBA lead was unsuccessfully implanted during the same procedure and was replaced on (b)(6) 2026. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50749651 ↗
• MalfunctionSep 14, 2026Under-Sensing

  It was reported that the patient presented remotely via Merlin.net. Review of the transmission indicated that the right ventricular (RV) lead exhibited declining ventricular sensing resulted in under sensing. No changes or intervention were reported; the RV lead will continue to be monitored. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50749593 ↗
• InjurySep 14, 2026Capturing Problem

  It was reported that the patient's postoperative evaluation noted that the right ventricular lead exhibited a high capture threshold. Chest X-ray was performed. The lead was explanted and replaced. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50748102 ↗
• 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 50748099 ↗
• DeathSep 11, 2026Failure to Capture

  It was reported that the patient presented for an initial implant of a pacemaker (PM) system post heart surgery (Bentall procedure). It was noted that the patient had a temporary pacing wire already inserted. The PM system was implanted successfully, and the temporary pacing wire was left insitu but inactivated. An hour post-procedure, the patient went into asystole, and cardiopulmonary resuscitation (CPR) was initiated, turning on the pacing wire; however, it was not capturing. The PM was interrogated, which showed no capture and an elevated pacing impedance. The patient subsequently passed. There are no allegations that the death is related to the PM system, and that the patient experienced an ischemic episode post-cardiac surgery.

  Patient problems: Arrhythmia

  MAUDE report 50742670 ↗
• MalfunctionSep 11, 2026Difficult to Fold, Unfold or Collapse; Fitting Problem; Capturing Problem

  It was reported that the patient presented to the hospital for a scheduled implant procedure. During the procedure, the left bundle branch area pacing (LBBP) lead helix kept retracting during lead torquing despite using mulitple helix locking tool. Due to the helix mechanism issue, the LBBP lead exhibited inappropriate capture. Additionally, the pacemaker header exhibited a setscrew anomaly. The pacemaker was implanted, however the LBBP lead was removed and replaced. The patient was in a stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50728338 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the hospital with an infection at the device implant site. The pacemaker, right atrial (RA) lead, and right ventricular (RV) lead were explanted. The patient remained in stable condition.

  Patient problems: Unspecified Infection

  MAUDE report 50726955 ↗
• InjurySep 11, 2026Device Sensing Problem; Device Dislodged or Dislocated

  It was reported that the patient presented to the clinic for a follow-up. It was noted that both the right atrial (RA) and right ventricular (RV) leads were dislodged due to Twiddler syndrome. The dislodgement of both the RA and RV leads were confirmed through chest X-ray. The RA lead exhibited a sudden increase in pacing impedance and a high capture threshold; however, the RV lead exhibited a decrease in sensing. Both the RA and RV leads were explanted and replaced. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50726767 ↗
• InjurySep 11, 2026Over-Sensing; Capturing Problem; Device Dislodged or Dislocated

  It was reported that during a post-implant check, device interrogation indicated that the patient's right atrial (RA) lead was oversensing ventricular signals and the electrocardiogram (ECG) was showing ventricular pacing spikes when doing AAI pacing. Chest X-Ray confirmed that the RA lead had dislodged. VVI pacing mode was programmed prior; the RA lead was subsequently repositioned on (b)(6) 2026. The patient was in stable condition throughout.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50725935 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient presented to clinic with pocket erosion and infection. A small hole was identified in the skin near the incision scar from the implantable cardioverter defibrillator (ICD) implantation. The patient confirmed non-compliance with post-discharge instructions. As a result, the ICD, right ventricular (RV), right ventricular Left Bundle Branch Pacing (RV-LBBP) and right atrial (RA) leads were explanted on (b)(6) 2026. Echocardiography findings indicated no vegetation on the leads. The explanted system was submitted for pathological evaluation related to the infection. The physician did not specify the cause of the infection or indicate whether the event was related to an Abbott product or procedure. The patient was stable throughout the procedure.

  Patient problems: Unspecified Infection

  MAUDE report 50705384 ↗
• InjurySep 10, 2026Failure to Capture; Retraction Problem

  It was reported that the patient presented for a post-procedure lead revision. It was noted that the right ventricular lead exhibited loss of capture prior to the patient's discharge from the hospital. During the lead revision procedure, it was also observed that the lead helix failed to retract. The lead was explanted and replaced. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50704038 ↗