Optisure™ LDA210Recalls & reported problems

Summary

The FDA's MAUDE database contains 147 adverse event reports that list this exact device (DI 05414734507172), received between Jun 19, 2018 and Jun 1, 2026 — classified as 6 deaths, 93 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (54 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 147 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Over-Sensing

  IT WAS REPORTED DURING REMOTE FOLLOW UP THAT THE RIGHT VENTRICULAR LEAD DISPLAYED OVERSENSING NOISE. THE PRODUCT WILL CONTINUE TO BE MONITORED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25350806 ↗
• InjuryApr 7, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION REVEALED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVER-SENSING RESULTING IN PACING INHIBITION. 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 24803164 ↗
• DeathMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY. THERE ARE NO KNOWN ALLEGATIONS FROM HEALTHCARE PROFESSIONALS INDICATING THAT THE DEATH WAS RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 24709650 ↗
• InjuryMar 18, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED OVERSENSING NOISE. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24635851 ↗
• MalfunctionFeb 18, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVERSENSING, RESULTING IN PACING INHIBITION. PROGRAMMING CHANGES WERE MADE TO RESOLVE THE ISSUE, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24381895 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC WITH AN INFECTION AT THE IMPLANTED DEVICE POCKET SITE. THE PHYSICIAN EXPLANTED THE ENTIRE SYSTEM ¿ IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR AND RIGHT VENTRICULAR LEAD DUE TO INFECTION. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 24032657 ↗
• MalfunctionDec 28, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT OVERSENSING WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. NO INTERVENTION WAS REPORTED. THE PATIENT CONDITION WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23904042 ↗
• MalfunctionDec 22, 2025Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Device Dislodged or Dislocated; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED INAPPROPRIATE SHOCK AND FAR P OVERSENSING DUE TO DISLODGE THAT WAS CONFIRMED VIA X-RAY. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865896 ↗
• InjuryDec 22, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED OVERSENSING NOISE AND INAPPROPRIATE VF DETECTION. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865008 ↗
• InjuryNov 26, 2025Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Device Dislodged or Dislocated; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Device Dislodged or Dislocated

  NEW INFORMATION RECEIVED NOTED THAT THE RV LEAD EXHIBITED NOISE OVERSENSING RESULTING IN INAPPROPRIATE SHOCK. FLUOROSCOPY AND X-RAY CONFIRMED THAT THE RV LEAD WAS DISLODGED. THE PHYSICIAN EXPLANTED AND REPLACED THE RV LEAD. THE PATIENT CONDITION WAS STABLE BEFORE, DURING, AND AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659832 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTION AND ENDOCARDITIS. THE PHYSICIAN EXPLANTED THE ACTIVE SYSTEM ¿ IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, RIGHT VENTRICULAR LEAD, LEFT VENTRICULAR LEAD AND RIGHT ATRIAL LEAD DUE TO THE INFECTION. THE PREVIOUSLY CAPPED RIGHT VENTRICULAR LEAD WAS ALSO EXPLANTED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 23482497 ↗
• InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ENDOCARDITIS AND HAD THEIR IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD), RIGHT ATRIAL LEAD, RIGHT VENTRICULAR LEAD, LEFT VENTRICULAR LEAD AND THE OLDER INACTIVE RIGHT VENTRICULAR LEAD WERE EXPLANTED AND REPLACED. THE PATIENT'S CONDITION WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22960098 ↗
• InjuryJul 22, 2025Over-Sensing; Therapy Delivered to Incorrect Body Area; Over-Sensing; Therapy Delivered to Incorrect Body Area

  IT WAS REPORTED DURING REMOTE FOLLOW UP THAT THE RIGHT VENTRICULAR LEAD EXHIBITED OVERSENSING OF NOISE. THE LEAD WAS CAPPED ON (B)(6) 2025 AND SUCCESSFULLY REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22569774 ↗
• MalfunctionJun 27, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY. REMOTE TRANSMISSION SHOWED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVERSENSING. NO INTERVENTION WAS PERFORMED. PATIENT HAD NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22352572 ↗
• InjuryJun 20, 2025Break; Over-Sensing; Break; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC. DEVICE INTERROGATION SHOWED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVERSENSING WHICH CAUSED PACING INHIBITION AND NOISE REVERSION. IT WAS SUSPECTED THAT THE RV LEAD HAD AN INSULATION BREACH. THE RV LEAD WAS CAPPED AND REPLACED ON (B)(6) 2025. PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22299594 ↗
• InjuryApr 25, 2025Over-Sensing; Over-Sensing

  NEW INFORMATION RECEIVED NOTES THAT A REVISION PROCEDURE WAS PERFORMED AND A NEW LEAD WAS IMPLANTED ON (B)(6) 2026. NO INFORMATION REGARDING ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21914625 ↗
• InjuryMar 19, 2025High impedance; High impedance

  IT WAS REPORTED A PATIENT'S RIGHT VENTRICULAR (RV) LEAD PRESENTED WITH HIGH PACING IMPEDANCE. REPROGRAMMING WAS PERFORMED AND THE LEAD WAS REVISED IN A PROCEDURE ON (B)(6) 2025. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21645599 ↗
• InjuryMar 13, 2025Failure to Capture; Use of Device Problem; Failure to Capture; Use of Device Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-17062. IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. UPON REVIEW, HIGH CAPTURE THRESHOLD AND LOSS OF CAPTURE WERE NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. AN X-RAY WAS PERFORMED, AND LACK OF RV LEAD SLACK WAS NOTED. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE RV LEAD. DURING THE PROCEDURE, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SET SCREW FAILED TO TIGHTEN. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE ICD. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596146 ↗
• InjuryMar 10, 2025High impedance; Use of Device Problem; High impedance; Use of Device Problem

  IT WAS REPORTED THAT PATIENT PRESENTED FOR FOLLOW-UP IN CLINIC. IT WAS NOTED THAT RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING IMPEDANCE. IT WAS ALSO OBSERVED VIA X-RAY THAT THERE WAS LACK OF LEAD SLACK. THE LEAD WAS EXPLANTED AND REPLACED WITH NEW LEAD. PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21561777 ↗
• InjuryFeb 11, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED A PATIENT'S RIGHT VENTRICULAR (RV) LEAD PRESENTED WITH NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING (NSRVO) DUE TO NOISE WITH INHIBITION OF PACING CAUSING THE PATIENT TO HAVE PAUSES. FLUOROSCOPY WAS PERFORMED AND IT SHOWED THE LEAD WAS IN A GOOD POSITION. THE LEAD WAS REVISED IN A PROCEDURE ON 7 FEB 2025 AND PROGRAMMING CHANGES WERE MADE TO RESTORE NORMAL PARAMETERS. POST-PROCEDURE THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21360383 ↗
• MalfunctionJan 20, 2025Capturing Problem; Capturing Problem

  PRODUCT REFERENCE NUMBER: 2017865-2025-11106. IT WAS REPORTED THAT THE PATIENT PRESENTED AT CLINIC FOR INTERROGATION OF THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). DURING THE EVALUATION, IT WAS DISCOVERED THAT THE ICD WAS EXHIBITING POST-SENSED T-WAVE OVERSENSING AND SHOWED SIGNS OF CROSSTALK. AN INCREASE IN THE CAPTURE THRESHOLD OF THE RIGHT VENTRICULAR (RV) LEAD WAS NOTED AS WELL. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21191293 ↗
• InjuryJan 7, 2025Difficult to Fold, Unfold or Collapse; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Device Dislodged or Dislocated; Difficult to Fold, Unfold or Collapse; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH DISLODGEMENT NOTED ON THE PATIENT RIGHT VENTRICULAR LEAD. THIS RESULTED IN OVER-SENSING AND INAPPROPRIATE SHOCK. A ROTATION ISSUE WAS NOTED DURING THE REVISION PROCESS. THE LEAD WAS EXPLANTED AND REPLACED ON DEC 18, 2024. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21096473 ↗
• MalfunctionDec 6, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED OVERSENSING NOISE. FURTHER INFORMATION WAS REQUESTED HOWEVER, WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20871227 ↗
• MalfunctionNov 21, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN EPISODE OF OVER-SENSING. IT WAS SUSPECTED THAT THE OVER-SENSING WAS DUE TO NOISE. NO INTERVENTION WAS PERFORMED AND THE PATIENT WILL BE FURTHER MONITORED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20749065 ↗
• InjuryNov 18, 2024Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  RELATED MANUFACTURER REFERENCE NUMBER: (B)(4). IT WAS REPORTED THAT A PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED AN IMPEDANCE ISSUE ON THE RIGHT ATRIAL LEAD AND OVER-SENSING OF NOISE ON THE RIGHT VENTRICULAR LEAD. INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) THERAPY WAS DELIVERED AS A RESULT OF THE OVER-SENSING. BOTH LEADS WERE CAPPED AND REPLACED ON (B)(6) 2024. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20703581 ↗

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