UltiPace™ LPA1231 (UDI 05415067046321)Recalls & reported problems

Summary

The FDA's MAUDE database contains 849 adverse event reports that list this exact device (DI 05415067046321), received between Oct 31, 2023 and Sep 30, 2026 — classified as 7 deaths, 326 injuries, 515 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (239 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 849 reports, 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, 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, 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, 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, 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 29, 2026Failure to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936438 ↗
• MalfunctionSep 29, 2026Difficult to Fold, Unfold or Collapse

  It was reported that the patient presented for an implant procedure. During the procedure, it was noted the right ventricular (RV) lead exhibited helix extension failure. The RV lead was not used and replaced. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928681 ↗
• MalfunctionSep 28, 2026Break

  It was reported that the patient presented to their healthcare facility for an implant procedure. During the procedure, after multiple attempts to find the optimal lead position, the physician noted that the helix of the lead was broken. The lead was not used, and the procedure was completed with a new lead. The patient was stable throughout.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917552 ↗
• MalfunctionSep 28, 2026Failure to Capture; Retraction Problem; Failure to Advance

  It was reported that the patient presented to the hospital for an implant procedure. During the procedure, the right ventricular (RV) lead exhibited loss of capture at high output. Following multiple repositioning attempts, the RV lead helix could not be retracted, and the stylet could not be advanced into the lead. The RV lead was removed and replaced. The patient was reported to be in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911180 ↗
• MalfunctionSep 28, 2026Fracture; Retraction Problem; Device Sensing Problem

  It was reported that the patient presented for a scheduled implant procedure. During the procedure, it was noted that the newly implanted right ventricular (RV) lead exhibited a sensing issue. While repositioning the lead, the helix of the RV lead failed to retract, and the lead fractured due to procedural damage. The RV lead was not implanted, and an alternate RV lead was implanted on (b)(6) 2026. The patient remained in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910797 ↗
• InjurySep 28, 2026Failure to Capture; Device Dislodged or Dislocated

  It was reported that the patient presented to the clinic for a follow-up. It was noted that the left bundle brunch area pacing (LBBAP) lead was suspected to have dislodged post-implantation and exhibited failure to capture. The LBBAP lead dislodgement was confirmed through chest X-ray. Programming changes was performed on (b)(6) 2025 and the LAABP lead subsequently explanted and replaced. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910597 ↗
• InjurySep 25, 2026Failure to Capture; Device Sensing Problem; Device Dislodged or Dislocated

  It was reported that the patient presented to their healthcare facility for a dual chamber pacemaker implant. During a pre-discharge device check, a decrease in R-wave amplitude and loss of capture were noted on the right ventricular (RV) lead. X-ray was performed and revealed dislodgement of the RV lead. The RV lead was explanted and replaced. The patient was stable following the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897915 ↗
• InjurySep 25, 2026Failure to Capture; Failure to Sense; Device Dislodged or Dislocated

  It was reported that the patient presented to hospital for an implant procedure. Prior to discharge, it was found that the right ventricular (RV) lead was dislodged, and it exhibited failure to capture and failure to sense. The RV lead dislodgement was confirmed through chest X-ray. The RV lead was explanted and replaced. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50894253 ↗
• MalfunctionSep 24, 2026Difficult to Fold, Unfold or Collapse; Capturing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889841 ↗
• MalfunctionSep 24, 2026Failure to Capture; Failure to Sense

  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 was failed to sense and failed to capture. Upon repositioning attempts, the failure to sense issue persisted. The RV lead was not used and replaced on 18 September 2026. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50877998 ↗
• MalfunctionSep 24, 2026Difficult to Fold, Unfold or Collapse; Capturing Problem; Device Dislodged or Dislocated

  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 had dislodged and exhibited unsatisfied capture threshold and QRS morphology. Attempts to reposition, the helix of the RV lead had failed to extend and the issues persisted. The RV lead dislodgement was confirmed by diagnostic imaging. The RV lead was not used and replaced on 24 June 2026. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876971 ↗
• MalfunctionSep 24, 2026Retraction Problem

  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 could not retract. The lead was not used. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876711 ↗
• InjurySep 23, 2026Capturing Problem

  It was reported that the dependent patient presented to clinic for a follow up. It was noted that the right ventricular (RV) exhibited high capture threshold. The RV lead was programmed to autocapture; the RV was subsequently capped and replaced on (b)(6) 2026. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863898 ↗
• MalfunctionSep 23, 2026Failure to Capture

  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 failure to capture. During repositioning attempt, the patient experienced bradycardia. The RV lead was not used and replaced on (b)(6) 2026. The patient was in stable condition.

  Patient problems: Arrhythmia

  MAUDE report 50863205 ↗
• InjurySep 18, 2026Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829646 ↗
• InjurySep 18, 2026Failure to Capture; Failure to Sense; Device Dislodged or Dislocated

  It was reported that the patient presented for a follow-up in clinic. Upon interrogation, it was noted that the right atrial (RA) and right ventricular (RV) lead exhibited loss of sensing and loss of capture. Chest X-ray revealed that the RA lead and RV lead had dislodged. Both RV lead and RA lead were explanted and replaced. The patient was discharged.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50813905 ↗
• MalfunctionSep 18, 2026Failure to Capture; Difficult to Fold, Unfold or Collapse; High impedance

  It was reported that the patient presented to the hospital for an implant procedure. During the procedure, it was noted that the low-voltage lead failed to retract the helix and failed to extend the helix. The low-voltage lead was not used and was replaced with a new low-voltage lead. The new low-voltage lead was found to have unspecified helix rotation issues, exhibited a rise in impedance and was unable to capture. The new low-voltage lead was not used and was replaced on (b)(6)2026. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50813819 ↗
• MalfunctionSep 18, 2026Difficult to Fold, Unfold or Collapse; Retraction Problem

  It was reported that the patient presented to the hospital for an implant procedure. During the procedure, it was noted that the low-voltage lead failed to retract the helix and failed to extend the helix. The low-voltage lead was not used and was replaced with a new low-voltage lead. The new low-voltage lead was found to have unspecified helix rotation issues, exhibited a rise in impedance and was unable to capture. The new low-voltage lead was not used and was replaced on (b)(6) 2026. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50813815 ↗
• InjurySep 17, 2026Insufficient Device Problem Information

  It was reported that the right ventricle lead and atrial lead were explanted for unknown reason. The patient condition was unknown.

  Patient problems: Insufficient Information

  MAUDE report 50798822 ↗
• MalfunctionSep 17, 2026Difficult to Fold, Unfold or Collapse; High impedance

  It was reported that the patient presented in clinic for initial implant procedure on (b)(6) 2026. During procedure, the right ventricular (RV) lead was placed at the septum Left Bundle Branch Area Pacing position and exhibited increased pacing impedance along with other stable parameters. Chest X-ray was performed and revealed RV lead dislodgement with its helix retracted. The RV lead helix was unable to be extended, despite multiple different attempts were performed. The RV lead was not implanted, and an alternate near at hand was implanted instead. Patient condition was stable throughout.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797394 ↗