OPTISURE™ LDA220Q-65Recalls & reported problems

Summary

The FDA's MAUDE database contains 266 adverse event reports that list this exact device (DI 05414734507363), received between Jun 19, 2018 and Aug 19, 2026 — classified as 9 deaths, 179 injuries, 78 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (62 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 266 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2026Failure to Capture; Device Dislodged or Dislocated

  It was reported that the patient presented to the emergency room complaining of stimulating chest pain. It was noted that the right ventricular (RV) lead exhibited high capture threshold and loss of capture. During the lead revision procedure, fluoroscopy confirmed micro-dislodgement of RV lead. The RV lead was explanted and replaced on (b)(6) 2026. The patient was in stable condition.

  Patient problems: Discomfort

  MAUDE report 50334420 ↗
• MalfunctionJul 29, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50077666 ↗
• MalfunctionJun 12, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED NOISE. PROGRAMMING CHANGES WERE PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25493008 ↗
• MalfunctionMay 11, 2026High impedance

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH DEFIB IMPEDANCE. THE LEAD REMAINS IMPLANTED. THE PATIENT IS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25135685 ↗
• MalfunctionMay 8, 2026Break; Over-Sensing

  DURING A REMOTE FOLLOW-UP, EPISODES OF NOISE WHICH RESULTED IN OVERSENSING WERE NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. LEAD DAMAGE WAS SUSPECTED BUT WAS NOT CONFIRMED. THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25128017 ↗
• MalfunctionApr 13, 2026Over-Sensing

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH MYOPOTENTIALS OVER-SENSING NOTED ON THE PATIENT'S RIGHT VENTRICULAR LEAD. CORRECTIVE PROGRAMMING CHANGES WERE RECOMMENDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24861347 ↗
• MalfunctionApr 1, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR ROUTINE FOLLOW UP. A DEVICE INTERROGATION REVEALED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH DEFIBRILLATION IMPEDANCE. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE THROUGHOUT AND CONTINUED TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24757460 ↗
• MalfunctionMar 20, 2026Break

  IT WAS REPORTED THAT DURING AN UNRELATED PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD WAS FOUND TO BE DAMAGED. THE PHYSICIAN ELECTED TO EXPLANT THE RV LEAD AND REPLACE IT WITH A NEW ONE. THE PATIENT¿S CONDITION REMAINED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24656243 ↗
• InjuryFeb 20, 2026Signal Artifact/Noise; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE EMERGENCY DEPARTMENT FOR UNKNOWN REASON. UPON DEVICE INTERROGATION, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE. CHEST X-RAY CONFIRMED RV LEAD DISLODGEMENT. THE RV LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2026. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24403644 ↗
• MalfunctionDec 5, 2025High impedance; High impedance

  IT WAS REPORTED THAT HIGH DEFIBRILLATION IMPEDANCE WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23732767 ↗
• MalfunctionNov 20, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT OVERSENSING OF NOISE WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD VIA REVIEW OF THE ELECTROGRAM (EGM). PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS ASYMPTOMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23605784 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC WITH AN INFECTION AT THE IMPLANTED DEVICE POCKET SITE. IT WAS NOTED THAT THE POCKET HAD BEEN RELOCATED IN SEPTEMBER DUE TO PATIENT DISCOMFORT. THE PHYSICIAN EXPLANTED THE ENTIRE SYSTEM ¿ IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR, RIGHT VENTRICULAR LEAD AND ATRIAL LEAD DUE TO INFECTION. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: Discomfort; Unspecified Infection

  MAUDE report 23582060 ↗
• MalfunctionNov 4, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE. THE NOISE OVER-SENSED. THE LEAD REMAINS IMPLANTED - BEING MONITORED. THE PATIENT IS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23464604 ↗
• InjuryOct 24, 2025Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Device Dislodged or Dislocated; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Device Dislodged or Dislocated

  NEW INFORMATION NOTED THAT THE ATRIAL FIBRILLATION WAS RESEOLVED BY CARDIOVERSION.

  Patient problems: Arrhythmia; Discomfort

  MAUDE report 23386209 ↗
• MalfunctionJul 24, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. UPON REVIEW OF REMOTE TRANSMISSION, IT WAS NOTED THAT THE LEFT-VENTRICULAR (LV) LEAD AND THE RIGHT-VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE. AS A RESOLUTION PROGRAMMING CHANGES WERE PERFORMED. THERE WERE NO PATIENT CONSEQUENCES, AND THE PATIENT WOULD BE CONTINUED TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22584899 ↗
• InjuryJul 23, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT FAILURE TO CAPTURE WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22581614 ↗
• InjuryJul 9, 2025Failure to Capture; Failure to Sense; Device Dislodged or Dislocated; Failure to Capture; Failure to Sense; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RIGHT-ATRIAL (RA) LEAD AND THE RIGHT-VENTRICULAR (RV) LEAD EXHIBITED FAILURE TO CAPTURE, FAILURE TO SENSE AND HAD DISLODGED WHICH WAS CONFIRMED VIA X-RAY IMAGING. AS A RESOLUTION THE RA AND RV LEADS WERE EXPLANTED AND REPLACED. THE PATIENT WAS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22464993 ↗
• InjuryJun 18, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN-CLINIC FOR A RIGHT-VENTRICULAR (RV) LEAD REPLACEMENT PROCEDURE AS PREVIOUSLY UPON INTERROGATION IT WAS NOTED THAT THE RV LEAD EXHIBITED OVERSENSING OF NOISE. RV LEAD FRACTURE WAS SUSPECTED BUT WAS NOT CONFIRMED FROM VISUAL INSPECTION. AS A RESOLUTION THE RV LEAD WAS EXPLANTED AND REPLACED. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22285355 ↗
• MalfunctionJun 11, 2025Defective Device; Defective Device

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 22185111 ↗
• MalfunctionMay 20, 2025High impedance; High impedance

  DURING A REMOTE FOLLOW-UP, INCREASED DEFIBRILLATION IMPEDANCE WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. TECHNICAL SUPPORT WAS CONTACTED, AND THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22056559 ↗
• InjuryMay 15, 2025Failure to Deliver Shock/Stimulation; Device Dislodged or Dislocated; Failure to Deliver Shock/Stimulation; Device Dislodged or Dislocated

  IT WAS REPORTED A PATIENT HAD FAILED SHOCKS IN THE FIELD, REQUIRING EXTERNAL DEFIBRILLATION. UPON X-RAY IT WAS NOTED THE RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED. THE LEAD WAS CAPPED AND REPLACED IN A PROCEDURE ON (B)(6) 2025. POST-PROCEDURE THE PATIENT WAS STABLE.

  Patient problems: Arrhythmia

  MAUDE report 22029338 ↗
• InjuryApr 4, 2025Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A RIGHT VENTRICULAR (RV) LEAD REVISION DUE TO HIGH THRESHOLD. THE RV LEAD WAS EXPLANTED AND REPLACED. THERE WERE NO ADVERSE HEALTH CONSEQUENCES, THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21773496 ↗
• InjuryApr 1, 2025Fracture; Over-Sensing; Fracture; Over-Sensing

  DURING A REMOTE FOLLOW UP, OVERSENSING WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. RV LEAD FRACTURE WAS SUSPECTED BUT THIS WAS NOT CONFIRMED. 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 21745697 ↗
• MalfunctionMar 25, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH HV LEAD IMPEDANCE. FURTHER INFORMATION WAS REQUESTED HOWEVER, WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21693852 ↗
• InjuryMar 17, 2025Failure to Capture; High impedance; Failure to Capture; High impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR MAGNETIC RESONANCE IMAGING. PRIOR TO IMAGING, DEVICE INTERROGATION SHOWED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH PACING IMPEDANCE, HIGH CAPTURE THRESHOLD, AND LOSS OF CAPTURE DUE TO SUSPECTED MINERALIZATION. PROGRAMMING CHANGES WERE MADE. PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21627692 ↗

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