OPTISURE™ LDA230Q-65Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 05414734507394), received between Jun 21, 2018 and Aug 19, 2026 — classified as 2 deaths, 21 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (5 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 30 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  It was reported that the system was explanted and replaced due to oversensing noise leading to inappropriate shock. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50327733 ↗
• MalfunctionFeb 10, 2026Intermittent Capture

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH INTERMITTENT CAPTURE NOTED ON THE PATIENT'S RIGHT VENTRICULAR LEAD. IN-CLINIC LEAD ASSESSMENT WAS RECOMMENDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24308906 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-12885. IT WAS REPORTED THAT A PATIENT PRESENTED WITH EROSION NOTED ON A LEAD IN THE PATIENT'S SYSTEM WITH PATIENT DISCOMFORT NOTED. THE LEAD POSITION WAS NOT SPECIFIED AND NO INFECTION WAS CONFIRMED. THE LEAD WAS REVISED AND WASHED OUT ON (B)(6) 2025. THE PATIENT WAS STABLE PRE, DURING, AND POST PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: Discomfort; Pocket Erosion

  MAUDE report 21360469 ↗
• MalfunctionJul 7, 2024High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR LEAD EXHIBITED HIGH IMPEDANCE. NO INTERVENTIONS WERE PERFORMED. THE PATIENT'S CONDITION WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19686613 ↗
• InjuryMar 5, 2024High impedance; Capturing Problem; High impedance; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP. DEVICE INTERROGATION REVEALED HIGH CAPTURE THRESHOLDS AND HIGH PACING AND DEFIBRILLATION IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE RV LEAD. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18842711 ↗
• MalfunctionDec 7, 2023Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT A PATIENT'S RIGHT VENTRICULAR LEAD EXHIBITED NOISE. NO CHANGES OR INTERVENTIONS WERE REPORTED. THE PATIENT CONDITION WAS NOT KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18287415 ↗
• DeathNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER:2017865-2023-52329. RELATED MANUFACTURER REFERENCE NUMBER:2017865-2023-52330. RELATED MANUFACTURER REFERENCE NUMBER:2017865-2023-52331. IT WAS REPORTED THAT THE PATIENT DECEASED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 18128198 ↗
• InjuryApr 10, 2023Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED NOISE. THE LEAD WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16705491 ↗
• InjuryFeb 22, 2023High impedance; Capturing Problem; High impedance; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. UPON INTERROGATION, IT WAS FOUND THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCREASED PACING IMPEDANCE AND INCREASED CAPTURE THRESHOLD. THE RV LEAD WAS CAPPED AND REPLACED ON 3 FEB 2023. PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16425118 ↗
• InjurySep 2, 2022Low impedance; Capturing Problem; Low impedance; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR IN-CLINIC FOLLOW-UP WITH AN INCREASED CAPTURE THRESHOLD AND DECREASED PACING IMPEDANCE EXHIBITED BY THE RIGHT VENTRICULAR LEAD. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2022. THE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15350873 ↗
• InjuryNov 8, 2021Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH CAPTURE THRESHOLDS. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN RECOVERING CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12775808 ↗
• MalfunctionNov 8, 2021Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT A PATIENT PRESENTED IN-CLINIC. UPON INTERROGATION, THE PATIENT'S HIGH VENTRICULAR (RV) LEAD WAS FOUND TO HAVE POST-PACED T-WAVE OVER-SENSING. CORRECTIVE PROGRAMMING CHANGES WERE MADE AND THE PATIENT WILL CONTINUE TO BE MONITORED. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12771791 ↗
• InjuryOct 8, 2021Over-Sensing; Over-Sensing

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-32684. IT WAS REPORTED THAT A PATIENT PRESENTED TO THE CLINIC ON (B)(6) 2021 WITH NOISE ON THEIR RIGHT ATRIAL LEAD, AS WELL AS NOISE THAT RESULTED IN OVERSENSING ON THEIR RIGHT VENTRICULAR LEAD. BOTH LEADS WERE EXPLANTED AND REPLACED ON (B)(6) 2021. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12601131 ↗
• InjuryOct 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER'S REFERENCE NUMBER: 2017865-2021-32404. RELATED MANUFACTURER'S REFERENCE NUMBER: 2017865-2021-32405. RELATED MANUFACTURER'S REFERENCE NUMBER: 2017865-2021-32407. IT WAS REPORTED THE PATIENT PRESENTED TO HOSPITAL DUE TO POCKET EROSION. THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, RIGHT VENTRICULAR, RIGHT ATRIAL, AND LEFT VENTRICULAR LEADS WERE EXPLANTED. A TEMPORARY PACEMAKER WAS PLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Erosion

  MAUDE report 12565281 ↗
• InjuryApr 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER'S REFERENCE NUMBER: 2017865-2021-16103, RELATED MANUFACTURER'S REFERENCE NUMBER: 2017865-2021-16104, RELATED MANUFACTURER'S REFERENCE NUMBER: 2017865-2021-16105. IT WAS REPORTED THE PATIENT PRESENTED IN THE OPERATING ROOM WITH A SUSPECTED INFECTION OR VEGETATION ON THE PATIENT'S LEADS. THE PATIENT'S IMPLANTABLE CARDIOVERTER MONITOR, RIGHT ATRIAL, RIGHT VENTRICULAR AND LEFT VENTRICULAR LEADS WERE EXPLANTED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 11732042 ↗
• InjuryDec 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTED MANUFACTURER NUMBER: 2017865-2020-21859, REPORTED MANUFACTURER NUMBER: 2017865-2020-21863. IT WAS REPORTED THE PATIENT PRESENTED FOR A POCKET REVISION PROCEDURE. A SINGULAR LEAD HAD ERODED THROUGH THE SKIN, BUT IT WAS NOT REPORTED IF IT WAS THE ATRIAL, RIGHT VENTRICULAR, OR LEFT VENTRICULAR LEAD. THE PHYSICIAN SUCCESSFULLY REVISED THE LEADS DURING PROCEDURE ON (B)(6) 2020. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Pocket Erosion

  MAUDE report 11000171 ↗
• InjuryNov 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2020-17660. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2020-17662. IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC UPON DEVELOPING AN INFECTION. THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, RIGHT VENTRICULAR LEAD, AND ATRIAL LEAD WERE EXPLANTED. THE PATIENT WAS STABLE.

  Patient problems: Unspecified Infection

  MAUDE report 10830452 ↗
• InjuryOct 22, 2020Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT EXCESSIVE NOISE WAS NOTED ON THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD. THE NOISE WAS REPRODUCIBLE AND TRIGGERED VENTRICULAR FIBRILLATION. THE PATIENT DID NOT RECEIVE SHOCK. PROGRAMMING CHANGES WERE MADE. COUPLE OF DAYS LATER, THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: Arrhythmia

  MAUDE report 10722616 ↗
• MalfunctionJul 29, 2020High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY. REVIEW OF THE TRANSMISSION REVEALED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE. INTERVENTION WAS DISCUSSED; NO INTERVENTION WAS REPORTED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10341508 ↗
• InjuryJul 10, 2020Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED UNDERSENSING. THE LEAD WAS CAPPED AND REPLACED (B)(6) 2020. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10261408 ↗
• InjuryApr 21, 2020Failure to Capture; Inappropriate/Inadequate Shock/Stimulation; Failure to Capture; Inappropriate/Inadequate Shock/Stimulation

  RELATED MANUFACTURER REFERENCE NUMBER: 2938836-2020-02625. IT WAS REPORTED THAT THE PATIENT HAD A LEFT VENTRICULAR ASSIST DEVICE (LVAD) AND PRESENTED IN THE EMERGENCY ROOM AFTER RECEIVING INAPPROPRIATE SHOCKS. THE PATIENT HAD LOW MAGNESIUM LEVEL. UPON DEVICE INTERROGATION, THE RIGHT VENTRICULAR AND ATRIAL LEADS EXHIBITED LOSS OF CAPTURE RESULTING IN SENSING ISSUE AND HIGH VOLTAGE THERAPY. THE SENSING WAS NOT CHANGED. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS STABLE BEFORE, DURING AND AFTER THE EVENT.

  Patient problems: Discomfort; Therapeutic Effects, Unexpected

  MAUDE report 9982646 ↗
• DeathOct 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2019-04135. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2019-15514. IT WAS REPORTED THAT PATIENT DECEASED AND THE PRIMARY CAUSE OF DEATH WAS UNKNOWN.

  Patient problems: Death

  MAUDE report 9247617 ↗
• InjuryAug 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2938836-2019-12333. RELATED MANUFACTURER REFERENCE NUMBER: 2938836-2019-12370. RELATED MANUFACTURER REFERENCE NUMBER: 2938836-2019-12372. IT WAS REPORTED THAT THE SYSTEM WAS EXPLANTED DUE TO INFECTION. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE INFECTION WAS RELATED TO THE DEVICE OR THE LEADS.

  Patient problems: Unspecified Infection

  MAUDE report 8895263 ↗
• MalfunctionMay 2, 2019Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT PATIENT PRESENTED DURING FOLLOW-UP IN-CLINIC. UPON REVIEW, THE PATIENT LEFT VENTRICULAR(LV) LEAD EXHIBITED LOSS OF CAPTURE. A CHEST X-RAY REVEALED THAT THE LV LEAD WAS WRAPPED AROUND THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR(ICD). DURING THE LV LEAD REVISION PROCEDURE, THE PHYSICIAN NOTICED THE RIGHT VENTRICULAR(RV) WAS WRAPPED AROUND THE ICD AS WELL AND THE LEADS HAD TANGLED TOGETHER. THE PHYSICIAN DESCRIBED THE INCIDENT AS TWIDDLER'S SYNDROME. BOTH THE LV AND RV LEADS WERE REPLACED. THE PATIENT WAS DISCHARGED. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2019-06374.

  Patient problems: Twiddlers Syndrome

  MAUDE report 8576351 ↗
• InjuryJan 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. THE INFECTION COULD BE SEEN ON THE SURFACE OF THE SKIN. THE PHYSICIAN DID NOT BELIEVE THAT THE INFECTION WAS CAUSED BY THE DEVICE. THE DEVICE SYSTEM WAS EXTRACTED. THE PATIENT WAS STABLE.

  Patient problems: Unspecified Infection

  MAUDE report 8259333 ↗

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