OPTISURE™ LDA210Q-65Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,706 adverse event reports that list this exact device (DI 05414734507332), received between Jun 11, 2018 and Sep 30, 2026 — classified as 43 deaths, 1,225 injuries, 438 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (384 reports).

3 other recalls cover devices cleared under the same FDA submission (P950022); they may or may not involve this specific model.

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 1,706 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Over-Sensing; Capturing Problem; Device Dislodged or Dislocated

  It was reported that the patient presented for a follow up in clinic. It was noted that high capture thresholds, an alert for false ventricular fibrillation (VF) due to oversensing, double counting of P waves and QRS complex were observed on the right ventricular (RV) lead. RV lead dislodgement was suspected. Programming changes were made to address the high capture thresholds. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950619 ↗
• InjurySep 29, 2026Over-Sensing

  It was reported that the patient's Right Ventricular (RV) lead exhibited oversensing, and noise oversensing was suspected. The physician elected to explant the RV lead and replace it with a new lead. The patient's condition was not known.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934510 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented for a follow-up in the clinic with infection at the implanted device pocket site and pocket erosion. The implantable cardioverter defibrillator was visible from the opened incision site of the implanted device pocket. The physician explanted the entire system ¿ implantable cardioverter-defibrillator, right ventricular lead, and atrial lead due to resolve the issue. The patient was in stable condition.

  Patient problems: Unspecified Infection

  MAUDE report 50933689 ↗
• 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 50910623 ↗
• MalfunctionSep 25, 2026Failure to Sense; Device Sensing Problem

  During an implant procedure, intermittent sensing was observed on the right ventricular (RV) lead. The lead was replaced to resolve the issue. The patient is in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903398 ↗
• MalfunctionSep 25, 2026Difficult to Fold, Unfold or Collapse; Retraction Problem

  It was reported that during the implant procedure, the lead screw was not extending/retracting properly. The lead was replaced. The patient is in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898839 ↗
• 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 50894238 ↗
• 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 50893286 ↗
• InjurySep 24, 2026Capturing Problem

  It was reported that the right ventricular lead displayed high capture threshold. Imaging did not reveal any physical issue. The product was explanted and successfully replaced. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889200 ↗
• InjurySep 23, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Device Dislodged or Dislocated

  It was reported that a patient presented with dislodgement of the right atrial and right ventricular leads. This resulted in over-sensing noise on both leads, which led to inappropriate shock on the right ventricular lead and inappropriate mode switch on the atrial lead. Both leads were explanted and replaced on (b)(6) 2026. No adverse patient consequences were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869051 ↗
• MalfunctionSep 18, 2026Low impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829437 ↗
• InjurySep 18, 2026Difficult to Fold, Unfold or Collapse; Device Sensing Problem; Device Dislodged or Dislocated

  It was reported that the patient's Right Ventricular (RV) lead exhibited a drop in sensing. Fluoroscopy was performed and revealed the RV lead had dislodged. During revision procedure, the helix of the RV lead failed to extend. The RV lead was explanted and replaced. The patient had no adverse consequences due to the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50828751 ↗
• MalfunctionSep 15, 2026Use of Device Problem; Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50778378 ↗
• InjurySep 15, 2026Device Dislodged or Dislocated

  It was reported that the patient presented for initial implant. Following the procedure, the Right Ventricular (RV) and Left Ventricular (LV) leads were noted to be dislodged. The physician explanted and replaced the RV and LV leads that same day. The patient condition was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766448 ↗
• InjurySep 11, 2026Failure to Capture; Under-Sensing; Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50744362 ↗
• 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 50705337 ↗
• InjurySep 9, 2026Fracture; High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50701514 ↗
• DeathSep 9, 2026Failure to Deliver Shock/Stimulation; Under-Sensing

  It was reported that alerts of non-sustained right ventricular oversensing episodes recorded ventricular tachycardia/ventricular fibrillation (VT/VF) with under sensing on the Implantable Cardioverter Defibrillator (ICD). Further information received notes the patient passed away at the time of the VT/VF episode. It was believed fine (VT/VF) arrhythmia was undersensed and therefore did not meet therapy parameters to deliver shock. No further information was provided.

  Patient problems: Arrhythmia

  MAUDE report 50699358 ↗
• InjurySep 8, 2026Failure to Capture; Low impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50679824 ↗
• InjurySep 3, 2026High impedance; Capturing Problem

  It was reported that a patient presented with high capture thresholds and an impedance problem. During the revision process, the initial replacement lead weas unable to be implanted. A new competitor lead was implanted to complete the revision. The lead was explanted on (b)(6) 2026. No adverse patient consequences were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50595600 ↗
• InjurySep 3, 2026Use of Device Problem

  It was reported that a patient presented with high capture thresholds and an impedance problem. During the revision process, the initial replacement lead weas unable to be implanted. A new competitor lead was implanted to complete the revision. The lead was explanted on (b)(6) 2026. No adverse patient consequences were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50595590 ↗
• InjurySep 3, 2026Failure to Capture; Over-Sensing; Device Dislodged or Dislocated

  It was noted that the patient presented remotely via Merlin.net. Review of the transmission revealed that the right ventricular (RV) and right atrial (RA) leads exhibited loss of capture and oversensing. Fluoroscopy confirmed that the RV and RA leads were dislodged and located in the incorrect chambers. The leads were explanted and replaced on (b)(6) 2026. The patient remained in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50594512 ↗
• InjurySep 2, 2026Failure to Capture; Failure to Sense; Device Dislodged or Dislocated

  It was reported that a loss of capture and loss of sensing were observed on the right ventricular (RV) lead. Diagnostic imaging was performed and confirmed a dislodgement of the RV lead. The RV lead was explanted and replaced to resolve the event. The patient was stable and will continue to be monitored.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50564120 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient's Right Ventricular (RV) lead was explanted and replaced for an unknown reason. The patient's condition was unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50547125 ↗
• InjuryAug 29, 2026Failure to Capture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50510031 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P950022. One submission often covers many models, so check the product and lot details in each record.

• Z-0660-2016 · Nov 3, 2015 · Terminated
  Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Car
• Z-0458-2012 · Nov 28, 2011 · Terminated
  St. Jude Medical Riata ST Silicone Endocardial Defibrillation Leads Riata(7Fr), Models: 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042 Product Usage: These Silicone transvenous
• Z-0457-2012 · Nov 28, 2011 · Terminated
  St. Jude Medical Riata (8Fr), Models: 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592 Product Usage: These Silicone transvenous high voltage (HV) leads co