OPTISURE™ LDA210Q-52Recalls & reported problems

Summary

The FDA's MAUDE database contains 141 adverse event reports that list this exact device (DI 05414734507318), received between Jul 12, 2018 and Sep 29, 2026 — classified as 4 deaths, 102 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (42 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 141 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026High impedance

  It was reported that the patient underwent a device exchange procedure on (b)(6) 2026. After the procedure, the patient was monitored remotely via Merlin.net. Review of the transmission revealed that the right ventricular (RV) lead exhibited high, out-of-range defibrillation impedance, and the left ventricular (LV) lead exhibited high, out-of-range pacing impedance. Diagnostic imaging confirmed that the leads were not properly secured in the set screws of the Implantable Cardioverter Defibrillator (ICD). During the lead revision procedure, the RV lead was found to be disconnected from the ICD, and the LV lead was also found to be loose. The RV and LV leads were cleaned and secured by tightening the set screws, and the impedance values returned to the normal range. The patient remained stable throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927578 ↗
• MalfunctionApr 9, 2026High impedance

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

  Patient problems: Insufficient Information

  MAUDE report 24835122 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE HOSPITAL DUE TO AN INFECTION AT THE DEVICE IMPLANT SITE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEAD WERE EXPLANTED. THE PATIENT'S CONDITION IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24628630 ↗
• InjuryFeb 16, 2026High impedance

  IT WAS REPORTED DURING IN CLINIC FOLLOW UP THAT THE RIGHT VENTRICULAR LEAD DISPLAYED HIGH PACING IMPEDANCE AND HIGH DEFIBRILLATION IMPEDANCE. IMAGING WAS DONE AND NO PHYSICAL ANOMALY WAS SEEN. THE PRODUCT WAS EXPLANTED AND SUCCESSFULLY REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24346714 ↗
• InjuryNov 26, 2025Failure to Capture; Low impedance; Device Dislodged or Dislocated; Failure to Capture; Low impedance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED DECREASED PACING IMPEDANCE AND LOSS OF CAPTURE. AN X-RAY WAS PERFORMED CONFIRMING RV LEAD DISLODGEMENT. THE PHYSICIAN EXPLANTED AND REPLACED THE RV LEAD. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659209 ↗
• InjuryOct 23, 2025Failure to Capture; Retraction Problem; Device Dislodged or Dislocated; Failure to Capture; Retraction Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE. FLUOROSCOPY WAS PERFORMED SHOWING THAT THE RV LEAD HAD BECOME DISLODGED. DURING THE REVISION PROCEDURE, THE HELIX FAILED TO RETRACT. THE PHYSICIAN EXPLANTED AND REPLACED THE RV LEAD. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23375890 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPLANTED DUE TO INFECTION. NO INTERVENTION HAS BEEN REPORTED FOR RIGHT VENTRICULAR (RV), RIGHT ATRIAL (RA) AND LEFT VENTRICULAR (LV) LEADS. NO PATIENT CONDITION OR FURTHER INFORMATION COULD BE OBTAINED.

  Patient problems: Unspecified Infection

  MAUDE report 22562329 ↗
• MalfunctionJul 21, 2025High impedance; Low impedance; High impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT-ATRIAL (RA) LEAD EXHIBITED LOW DEFIBRILLATION IMPEDANCE ALONG WITH HIGH DEFIBRILLATION IMPEDANCE. NO RESOLUTION WAS PERFORMED. THE PATIENT CONDITION WAS STABLE AND WOULD CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22561735 ↗
• MalfunctionMay 28, 2025Failure to Capture; Over-Sensing; Device Dislodged or Dislocated; Failure to Capture; Over-Sensing; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT A CHEST X-RAY WAS PERFORMED AND CONFIRMED THAT THE RIGHT VENTRICULAR LEAD WAS NOT DISLODGED AND NO FURTHER NON-CAPTURE WAS NOTED. THE PATIENT'S CONDITION WAS REPORTED AS UNSTABLE DUE TO NON-DEVICE RELATED FACTORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22100951 ↗
• InjuryApr 22, 2025High impedance; Capturing Problem; High impedance; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION REVEALED HIGH PACING IMPEDANCE AND HIGH CAPTURE THRESHOLD ON THE RIGHT VENTRICULAR (RV) LEAD. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE RV LEAD. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21882958 ↗
• InjuryApr 2, 2025Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC WITH WOUND DEHISCENCE AND DEVELOPED AN INFECTION AT THE IMPLANTED DEVICE POCKET SITE. THE PHYSICIAN EXPLANTED IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR, LEFT VENTRICULAR LEAD, AND ATRIAL LEAD DUE TO AN INFECTION. THE RIGHT VENTRICULAR LEAD WAS CAPPED ON (B)(6) 2025 BECAUSE IT COULD NOT BE REMOVED FROM THE PATIENT'S BODY. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 21759242 ↗
• InjuryMar 24, 2025Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Under-Sensing; Device Dislodged or Dislocated; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Under-Sensing; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT PRESENTED WO THE EMERGENCY ROOM WITH OVER-SENSING, UNDER-SENSING AND INAPPROPRIATE SHOCK DUE TO DISLODGEMENT OD THE RIGHT VENTRICULAR LEAD CONFIRMED ON X-RAY. THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2025. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21679312 ↗
• InjuryMar 12, 2025Over-Sensing; Device Dislodged or Dislocated; Over-Sensing; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AT THE POST-PROCEDURE CHECK, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVER-SENSING OF ATRIAL AND VENTRICULAR SIGNALS. A CHEST X-RAY SHOWED THE RV LEAD HAD PULLED BACK AND DISLODGED. THE RV LEAD WAS REPOSITIONED ON (B)(6) 2025. THERE WERE NO ADVERSE HEALTH CONSEQUENCES, THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21584957 ↗
• MalfunctionMar 12, 2025Intermittent Capture; Intermittent Capture

  IT WAS REPORTED THAT A PATIENT PRESENTED TO CLINIC FOR FOLLOW UP. DEVICE INTERROGATION REVEALED INTERMITTENT CAPTURE ON THE RIGHT VENTRICULAR (RV) LEAD. NO CHANGES OR INTERVENTIONS WERE PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21584413 ↗
• InjuryFeb 25, 2025Fracture; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Fracture; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED DURING IN CLINIC FOLLOW UP THAT THE RIGHT VENTRICULAR LEAD EXHIBITED OVERSENSING DUE TO NOISE. FRACTURE WAS SUSPECTED DUE TO NOISE. THE LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21464918 ↗
• InjuryFeb 25, 2025High impedance; High impedance

  IT WAS REPORTED DURING REMOTE FOLLOW UP THAT THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH PACING IMPEDANCE. NO INTERVENTION WAS REPORTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21458876 ↗
• InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-12492, 2017865-2025-12493. IT WAS REPORTED THAT PATIENT PRESENTED WITH FEVER, PUSS AND BLEEDING AT POCKET SITE. IT WAS ALSO NOTED THAT PATIENT HAD AN INFECTION. THE IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD), RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS WERE EXPLANTED AND REPLACED AS A RESULT. PATIENT CONDITION WAS STABLE.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 21327343 ↗
• InjuryJan 28, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT A PATIENT PRESENTED TO CLINIC FOR FOLLOW UP. DEVICE INTERROGATION REVEALED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS NOT CAPTURING. X-RAY WAS PERFORMED AND REVEALED CARDIAC PERFORATION OF THE RV LEAD. ON (B)(6) 2025, THE PHYSICIAN ELECTED TO CAP AND REPLACE THE RV LEAD. THE PATIENT CONDITION WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: Cardiac Perforation

  MAUDE report 21252764 ↗
• InjuryJan 13, 2025Therapy Delivered to Incorrect Body Area; Therapy Delivered to Incorrect Body Area

  IT WAS REPORTED THAT PATIENT PRESENTED TO EMERGENCY ROOM AFTER EXPERIENCING DIAPHRAGM AND PHRENIC NERVE STIMULATION. IT WAS FURTHER NOTED FROM X-RAY THAT PATIENT'S RIGHT VENTRICULAR (RV) LEAD PERFORATED THE RV EPICAL WALL. THE LEAD WAS EXPLANTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Cardiac Perforation; Discomfort

  MAUDE report 21143974 ↗
• MalfunctionNov 14, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION REVEALED THAT RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVER SENSED NOISE LEADING TO PACING INHIBITION. NO INTERVENTION WAS PERFORMED. PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20685786 ↗
• InjuryOct 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED A PATIENT'S RIGHT VENTRICULAR (RV) AND ATRIAL LEADS PRESENTED WITH NUMEROUS ELECTRICAL ANOMALIES DUE TO DISLODGEMENT, CONFIRMED VIA X-RAY. THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED IN A PROCEDURE ON (B)(6) 2024, WHILE THE ATRIAL LEAD WAS REVISED AND REUSED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20541679 ↗
• MalfunctionOct 16, 2024High impedance; High impedance

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461682 ↗
• InjuryAug 15, 2024Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated

  RELATED MANUFACTURER REFERENCE NUMBER: (B)(4). IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP. DEVICE INTERROGATION REVEALED FAILURE TO CAPTURE DISLODGEMENT DUE TO TWIDDLERS AND CONFIRMED VIA DIAGNOSTIC IMAGING ON THE RIGHT VENTRICULAR (RV) LEAD AND THE ATRIAL (RA) LEAD. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE BOTH THE RV AND RA LEAD. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19997316 ↗
• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR EXPLANT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND VENTRICULAR LEAD DUE TO INFECTION. THE DEVICE WAS IMPLICATED AS A POTENTIAL SITE OF INFECTION. THE PATIENT WAS STABLE.

  Patient problems: Unspecified Infection

  MAUDE report 19989261 ↗
• InjuryAug 14, 2024Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE PATIENT HAD POCKET INFECTION AND EROSION. THE ENTIRE IMPLANTABLE CARDIAC DEFIBRILLATOR SYSTEM WAS EXPLANTED. WHILE EXPLANTING THE RIGHT VENTRICULAR LEAD, THE HELIX EXHIBITED RETRACTION PROBLEM. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 19981339 ↗

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