OPTISURE™ LDA220Q-58Recalls & reported problems

Summary

The FDA's MAUDE database contains 334 adverse event reports that list this exact device (DI 05414734507356), received between Jun 11, 2018 and Sep 9, 2026 — classified as 19 deaths, 218 injuries, 97 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (80 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 334 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Failure to Capture; Under-Sensing; Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50701574 ↗
• MalfunctionAug 24, 2026Over-Sensing; Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50411547 ↗
• MalfunctionAug 8, 2026Failure to Capture; Fracture; Over-Sensing; Device Sensing Problem

  It was reported that oversensing noise, low R waves and loss of capture was observed on the right ventricular (RV) lead. Ventricular Autocapture was in high output mode. A RV lead fracture was suspected.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50184743 ↗
• MalfunctionJun 29, 2026Failure to Disconnect; Device Dislodged or Dislocated

  IT WAS REPORTED THAT EPISODES OF NOISE CAUSING INAPPROPRIATE RV (RIGHT VENTRICULAR) PACING, MODE SWITCHING, AND PACING INHIBITION WERE NOTED ON THE RIGHT ATRIAL (RA) LEAD. FLUOROSCOPY SHOWED NO RA LEAD DAMAGE, BUT IT WAS DIFFICULT TO PLACE THE LOCKING STYLET DOWN THE LEAD PAST THE CLAVICLE AREA. LOW SENSING AND DECREASED PACING IMPEDANCE WERE NOTED DURING THE PROCEDURE. DURING REVISION, THE RA AND RV LEADS WERE FOUND ADHERED TOGETHER; SUBSEQUENT LASER EXTRACTION OF THE RA LEAD INADVERTENTLY DISPLACED THE RV LEAD DUE TO THESE ATTACHMENTS. BOTH LEADS WERE EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION WITH NO ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25661144 ↗
• MalfunctionJun 11, 2026Over-Sensing

  IT WAS REPORTED THAT AUTO MODE SWITCHING (AMS), OVERSENSING NOISE AND LOW SENSING WAS OBSERVED ON THE RIGHT ATRIAL (RA) LEAD. THE LOW P WAVES WERE DUE TO OVERSENSING OF FINE RIGHT VENTRICULAR (RV) LEAD NOISE.

  Patient problems: Insufficient Information

  MAUDE report 25478664 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH INFECTION AND VEGETATION ON THE LEADS. THE PHYSICIAN ELECTED TO EXPLANT THE ENTIRE SYSTEM, INCLUDING THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), THE RIGHT ATRIAL LEAD, THE RIGHT VENTRICULAR LEAD, AND THE LEFT VENTRICULAR LEAD. THE PATIENT REMAINED IN STABLE CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 25112633 ↗
• InjuryMar 30, 2026Signal Artifact/Noise; Failure to Capture; Device Dislodged or Dislocated

  NEW INFORMATION RECEIVED NOTES THAT SOME VENTRICULAR LEAD NOISE SPARKED INITIAL INTERROGATION BUT DID NOT TRIGGER ANY INAPPROPRIATE EVENT ON THE RIGHT VENTRICULAR (RV) LEAD PRIOR TO THE PROCEDURE. THE PATIENT WAS STABLE BEFORE, DURING, AND AFTER THE PROCEDURE. FOLLOW UP CHECKS WERE WITHIN NORMAL PARAMETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24735185 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN ELEVATED WHITE BLOOD CELL COUNT AND WAS FOUND TO HAVE VEGETATION ON THE RIGHT VENTRICULAR (RV) LEAD VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) AND THE RV LEAD WERE EXPLANTED DUE TO THE INFECTION. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 24438876 ↗
• InjuryFeb 23, 2026Failure to Convert Rhythm

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF ABDOMINAL AND CHEST DISCOMFORT AND WAS HOSPITALIZED. THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION (VF) THAT REQUIRED THREE ROUNDS OF ANTITACHYCARDIA PACING THERAPY (ATP)/(VF) SHOCK THERAPY. THE THERAPIES WERE UNSUCCESSFUL AND REQUIRED EXTERNALLY DELIVERED BIPHASIC SHOCK THAT WAS SUCCESSFUL. THE PATIENT WAS STABILIZED AND EVENTUALLY TRANSPORTED AFTER ECHOCARDIOGRAM RESULTS REVEALED POSSIBLE VEGETATION TO THE RV LEAD. THE PATIENT REMAINED AFEBRILE DURING THIS TIME. SUBSEQUENT TESTS AND DIAGNOSIS CONFIRMED BACTEREMIA, ENDOCARDITIS AND CARDIOGENIC SHOCK. THE SYSTEM WAS EXPLANTED. THE PATIENT RECEIVED ANTIBIOTICS AND WAS SET TO RECEIVE A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE PATIENT WAS SUBSEQUENTLY TRANSFERRED BACK TO THE FACILITY¿S INTENSIVE CARE UNIT IN STABLE CONDITION.

  Patient problems: Arrhythmia; Discomfort; Unspecified Infection

  MAUDE report 24424495 ↗
• DeathFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DECEASED. THERE IS NO ALLEGATION FROM A HEALTHCARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH WAS CARDIAC ARREST AND CARDIOMYOPATHY.

  Patient problems: Insufficient Information

  MAUDE report 24411446 ↗
• InjuryFeb 9, 2026High impedance; Use of Device Problem; Capturing Problem

  IT WAS REPORTED DURING IN CLINIC FOLLOW UP THAT THE RIGHT VENTRICULAR LEAD DISPLAYED HIGH CAPTURE THRESHOLD AND HIGH PACING IMPEDANCE. ON IMAGING, LACK OF LEAD SLACK WAS NOTED. THE PRODUCT WAS EXPLANTED AND SUCCESSFULLY REPLACED. PATIENT WAS STABLE BEFORE AND AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24299103 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED IN CLINIC AFTER BEING FOUND UNRESPONSIVE. IT WAS NOTED THAT THE PACEMAKER POCKET WAS SWOLLEN. THE WHOLE SYSTEM INCLUDING THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND THE RIGHT VENTRICULAR (RV) LEAD, WAS EXPLANTED. BLOOD CULTURE WAS PERFORMED AND FOUND THAT THE PATIENT HAD DEVELOPED SEPSIS INFECTION AND ENDOCARDITIS. THE PATIENT WOULD CONTINUE TO BE MONITORED AT THE HOSPITAL.

  Patient problems: Hematoma; Syncope/Fainting; Unspecified Infection

  MAUDE report 24293285 ↗
• InjuryFeb 2, 2026Capturing Problem; Device Sensing Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED AT CLINIC FOR A FOLLOW-UP VISIT. IT WAS DISCOVERED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD HAD EXHIBITED HIGH CAPTURE THRESHOLD AND R-WAVE AMPLITUDE VARIATION. FLUOROSCOPY HAD ALSO REVEALED THAT THE RV LEAD HAD DISLODGED. THE RV LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24237522 ↗
• InjuryJan 27, 2026Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH A HIGH CAPTURE THRESHOLD ON THEIR RIGHT VENTRICULAR (RV) LEAD. THE PRODUCT WAS EXPLANTED AND SUCCESSFULLY REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24190927 ↗
• MalfunctionJan 19, 2026High impedance

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH HIGH DEFIBRILLATION IMPEDANCE NOTED ON THE PATIENT'S RIGHT VENTRICULAR LEAD. PROGRAMMING CHANGES AND LEAD EVALUATION WAS SUGGESTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24111864 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), THE RIGHT ATRIAL (RA) LEAD AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN INFECTION. THE ICD WAS OBSERVED TO HAVE ERODED. THE FULL SYSTEM, INCLUDING THE ICD, THE RA AND THE RV LEAD, WAS EXPLANTED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 24031087 ↗
• InjuryJan 6, 2026Signal Artifact/Noise; Capturing Problem; Device Sensing Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC FOR FOLLOW UP. UPON DEVICE INTERROGATION, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED R-WAVE AMPLITUDE VARIATION, CAPTURING ISSUE, NOISE PROBLEM. CHEST X-RAY CONFIRMED RV LEAD DISLODGEMENT. THE RV LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2025. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23984341 ↗
• MalfunctionJan 5, 2026Intermittent Capture

  IT WAS REPORTED DURING REMOTE FOLLOW UP THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXHIBITING INAPPROPRIATE MODE SWITCH EPISODES AND THE ASSOCIATED RIGHT VENTRICULAR (RV) LEAD SHOWED INTERMITTENT CAPTURE. NO INTERVENTION WAS REPORTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23969936 ↗
• MalfunctionJan 2, 2026High impedance

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH HIGH IMPEDANCE NOTED ON THE PATIENT'S RIGHT VENTRICULAR LEAD. NO INTERVENTION OR ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23946295 ↗
• MalfunctionDec 17, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT POST-PACED T-WAVE OVERSENSING (PPTWOS) WAS NOTED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD. NO CHANGES OR INTERVENTION WAS REPORTED. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23832717 ↗
• MalfunctionNov 26, 2025High impedance; High impedance

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE RIGHT VENTRICULAR LEAD DISPLAYED FURTHER INSTANCES OF HIGH DEFIB IMPEDANCE ON REMOTE FOLLOW UP. THE PRODUCT WILL CONTINUE TO BE MONITORED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23663066 ↗
• InjuryNov 11, 2025Failure to Capture; High impedance; Failure to Sense; Device Dislodged or Dislocated; Failure to Capture; High impedance; Failure to Sense; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH DISCOMFORT IN THE POCKET REGION. UPON X-RAY, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS PULLED INTO THE SVC/CLAVICULAR VEINS. LOSS OF CAPTURE, NO SENSING, AND HIGH PACING IMPEDANCE WERE OBSERVED. THE RV LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION WITH NO ADVERSE HEALTH CONSEQUENCES.

  Patient problems: Discomfort

  MAUDE report 23523822 ↗
• MalfunctionNov 7, 2025Over-Sensing; Over-Sensing

  NEW INFORMATION NOTED THAT THERE WERE NO PATIENT CONSEQUENCES AND PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23500540 ↗
• MalfunctionNov 6, 2025High impedance; High impedance

  IT WAS REPORTED A PATIENT'S RIGHT VENTRICULAR (RV) LEAD PRESENTED WITH HIGH DEFIBRILLATION IMPEDANCE. NO CHANGES WERE REPORTED. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490950 ↗
• InjuryNov 4, 2025High impedance; Capturing Problem; High impedance; Capturing Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH HIGH PACING IMPEDANCE AND CAPTURE THRESHOLDS NOTED ON THE PATIENT'S RIGHT VENTRICULAR LEAD. DURING THE LEAD REVISION PROCESS, THE RIGHT ATRIAL AND LEFT VENTRICULAR LEADS WERE DAMAGED. ALL THREE LEADS WERE EXPLANTED AND REPLACED ON (B)(6) 2025. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23470383 ↗

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