OPTISURE™ LDA210Q-58Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,441 adverse event reports that list this exact device (DI 05414734507325), received between Jun 13, 2018 and Sep 30, 2026 — classified as 69 deaths, 1,647 injuries, 725 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (577 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 2,441 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Capturing Problem

  It was reported that the patient's Right Ventricular (RV) lead exhibited high capture thresholds. No intervention was performed. The patient was stable throughout.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949624 ↗
• InjurySep 30, 2026Difficult to Fold, Unfold or Collapse; Over-Sensing

  Additional information received indicated that the Right Ventricular (RV) lead exhibited noise oversensing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949246 ↗
• MalfunctionSep 29, 2026Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935407 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the clinic with an infection. The physician explanted the entire pacing system, consisting of the implantable cardioverter-defibrillator (ICD) and right ventricular (RV) lead, and replaced it with a leadless pacemaker on (b)(6) 2026. The patient remained in stable condition.

  Patient problems: Unspecified Infection

  MAUDE report 50928387 ↗
• InjurySep 28, 2026Failure to Capture; Fracture; High impedance

  It was reported that the Right Ventricular (RV) lead exhibited loss of capture and high impedance. The RV lead was noted to be fractured. On (b)(6) 2026, the physician capped and replaced the RV lead. The patient was discharged following the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917303 ↗
• InjurySep 25, 2026Failure to Capture; Failure to Sense; Device Dislodged or Dislocated

  It was reported that the patient presented remotely via Merlin.net due to their right ventricular (RV) lead exhibiting a failure to sense. The patient was brought into clinic and it was also noted that there was no capture, and the RV lead had dislodged. The RV lead was explanted and successfully replaced. The patient was discharged.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903143 ↗
• MalfunctionSep 24, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50891875 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that, the right ventricular (RV) lead was explanted and replaced. Additional information was requested but was not provided. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883957 ↗
• InjurySep 24, 2026Break; Over-Sensing

  It was reported that, noise resulting in oversensing was noted on the right ventricular (RV) lead. RV lead damage was suspected but this was not confirmed. Provocative maneuvers were performed; the noise was not reproducible. The RV lead was capped and replaced to resolve this event. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883233 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the hospital with a pocket infection. The physician explanted the implantable cardioverter defibrillator, right ventricular lead, right atrial lead, and left ventricular lead. The patient remained in stable condition.

  Patient problems: Unspecified Infection

  MAUDE report 50863288 ↗
• InjurySep 18, 2026Break; Over-Sensing

  It was reported that noise resulting in oversensing were observed on the right ventricular (RV) lead. RV lead damage was alleged but not confirmed. The RV lead was explanted and replaced to resolve event. The patient was stable with no consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50823617 ↗
• InjurySep 18, 2026Capturing Problem

  It was reported that the patient presented for in clinic follow-up. Device interrogation revealed that the Right Ventricular (RV) lead exhibited high capture threshold. An X-Ray was performed; however, the results were unknown. The physician explanted and replaced the RV lead. There were no patient consequences reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820720 ↗
• MalfunctionSep 16, 2026Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794744 ↗
• InjurySep 16, 2026Low impedance; Device Dislodged or Dislocated

  Additional information was received that there was low impedance.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794347 ↗
• MalfunctionSep 11, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50743719 ↗
• MalfunctionSep 11, 2026Failure to Capture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50740610 ↗
• InjurySep 11, 2026Device Dislodged or Dislocated

  It was reported that during a follow up, it was discovered that Right Ventricular (RV) lead dislodged. Dislodgement was confirmed by EKG. The lead was explanted and replaced. The patient is in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50733474 ↗
• MalfunctionSep 4, 2026High impedance; Capturing Problem

  It was reported that Right Ventricular (RV) exhibited increased capture threshold and increased pacing impedance via Remote Monitoring. The patient has no symptoms. The lead will be monitored remotely.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50612866 ↗
• InjurySep 3, 2026Use of Device Problem; Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50599228 ↗
• MalfunctionSep 2, 2026Break; Therapy Delivered to Incorrect Body Area

  Additional information was received indicating that lead insulation damage was suspected.

  Patient problems: Discomfort

  MAUDE report 50568056 ↗
• MalfunctionSep 2, 2026High impedance; Capturing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50566655 ↗
• MalfunctionSep 1, 2026Difficult to Fold, Unfold or Collapse; Use of Device Problem; Insufficient Device Problem Information

  It was reported that the patient presented for a scheduled implant procedure. During the procedure, it was noted that the newly placed right ventricular (RV) lead exhibited a negative current of injury. While repositioning the lead, the helix failed to extend. The RV lead was subsequently explanted and replaced with an alternate lead on (b)(6) 2026. The patient remained in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50552914 ↗
• InjuryAug 29, 2026High impedance; Capturing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50510202 ↗
• InjuryAug 27, 2026Failure to Capture; Failure to Sense

  It was reported that the right ventricular lead could not pace or sense. The right ventricular (RV) lead was explanted and replaced. The patient was discharged from the operating room to the intensive care unit for recovery.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50477370 ↗
• MalfunctionAug 26, 2026Over-Sensing; Device Sensing Problem; Device Dislodged or Dislocated

  During a remote follow-up, decreased sensing and far-field P-wave oversensing (FFPWOS) were observed on the right ventricular (RV) lead. An X-ray was performed and the RV lead was found to be dislodged. No intervention has been performed but a revision is anticipated. The patient is stable with no consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50459527 ↗

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-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
• 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