Optisure™ LDA220Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 05414734507202), received between Nov 26, 2018 and Feb 4, 2026 — classified as 1 death, 10 injuries, 9 malfunctions.

The most frequently reported specific device problem is “High impedance” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVER-SENSING, WHICH RESULTED IN PACING INHIBITION. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260786 ↗
• MalfunctionJan 5, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE. NO INTERVENTION WAS PERFORMED. THE PATIENT HAD NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23968148 ↗
• InjuryNov 14, 2025Fracture; High impedance; Over-Sensing; Fracture; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED AT THE HOSPITAL FOR DIZZINESS AND NEAR SYNCOPE. REMOTE TRANSMISSION REVEALED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNSPECIFIED OVERSENSING, LEADING TO PACING INHIBITION, AND A HIGH PACING IMPEDANCE. THE RV LEAD WAS ALSO REPORTED TO HAVE FRACTURED. PROGRAMMING CHANGES WERE MADE, AND THE RV LEAD WAS CAPPED ON (B)(6) 2025, AND SUCCESSFULLY REPLACED. THE PATIENT WAS STABLE.

  Patient problems: Dizziness

  MAUDE report 23560036 ↗
• MalfunctionMay 2, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A PROCEDURE, THE LEAD STYLET WOULD NOT PASS THROUGH THE LEAD. THE LEAD WAS REPLACED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21955761 ↗
• InjuryOct 24, 2024Failure to Capture; Device Sensing Problem; Failure to Capture; Device Sensing Problem

  IT WAS REPORTED DURING IN CLINIC FOLLOW UP THAT THE RIGHT VENTRICULAR LEAD EXHIBITED A FAILURE TO CAPTURE AND LOW SENSING AMPLITUDES. THE LEAD WAS CAPPED ON (B)(6) 2024. THE PATIENT WAS STABLE AND ASYMPTOMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20521957 ↗
• InjuryOct 12, 2024Failure to Capture; Fracture; Device Sensing Problem; Failure to Capture; Fracture; Device Sensing Problem

  IT WAS REPORTED A PATIENT'S RIGHT VENTRICULAR (RV) LEAD PRESENTED WITH A FRACTURE, CONFIRMED VIA FLUOROSCOPY. A DEVICE SENSING PROBLEM AND FAILURE TO CAPTURE WERE ALSO NOTED. THE LEAD WAS CAPPED AND REPLACED IN A PROCEDURE ON (B)(6) 2024. POST-PROCEDURE THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20434936 ↗
• MalfunctionFeb 14, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP. DEVICE INTERROGATION REVEALED POST PACED T WAVE OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. PROGRAMMING CHANGES WERE PERFORMED TO RESOLVE THE ISSUE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18708293 ↗
• MalfunctionFeb 6, 2024Failure to Capture; Over-Sensing; Failure to Capture; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT WAS UNCOMFORTABLE AND CONCERNED. VENTRICULAR OVERSENSING DUE TO MYOPOTENTIAL NOISE AND NO PACING WAS OBSERVED. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS STABLE AND BEING MONITORED.

  Patient problems: Discomfort

  MAUDE report 18656007 ↗
• InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-22194, RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-22195. IT WAS REPORTED A PATIENT PRESENTED WITH POCKET PAIN. THE SYSTEM WAS EXPLANTED AND REPLACED IN A PROCEDURE ON (B)(6) 2023. POST-PROCEDURE THE PATIENT WAS STABLE.

  Patient problems: Discomfort

  MAUDE report 17044301 ↗
• MalfunctionOct 4, 2022Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED NOISE. FURTHER INFORMATION WAS REQUESTED, BUT IS NOT YET AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15537279 ↗
• DeathSep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBER: 2017865-2022-38361 AND 2017865-2022-38363. IT WAS REPORTED THAT THE PATIENT HAD DECEASED. THE CAUSE OF DEATH WAS CARDIAC ARRHYTHMIA, DILATED CARDIOMYOPATHY AND CARDIOMEGALY. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15438222 ↗
• InjuryJul 20, 2021Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED IN-CLINIC FOR A ROUTINE DEVICE CHECK. UPON INTERROGATION, THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH CAPTURE THRESHOLDS. EXPLANT AND REPLACEMENT PROCEDURE FOR THE RV WAS ATTEMPTED ON (B)(6) 2021 BUT WAS ABANDONED DURING PROCEDURE DUE TO PATIENT ANATOMY. A NEW EXTRACTION PROCEDURE WAS SCHEDULED BUT WAS NOT YET PERFORMED. THE PATIENT DID NOT SUFFER ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12196810 ↗
• InjuryMar 30, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11588881 ↗
• MalfunctionMar 3, 2021High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR REMOTE FOLLOW UP VIA MERLIN.NET WITH AN ALERT FOR HIGH PACING IMPEDANCE. THE PATIENT WAS STABLE AND WILL BE SCHEDULED FOR REPLACEMENT OF THE RIGHT VENTRICULAR LEAD. THERE WERE OTHER INTERVENTIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11405035 ↗
• InjuryOct 28, 2020High impedance; High impedance

  IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED REMOTELY VIA MERLIN.NET WITH HIGH OUT OF RANGE PACING IMPEDANCE. PATIENT ALSO RECEIVED A VIBRATORY ALERT. LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2020. PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10750214 ↗
• InjuryJul 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBER: 2017865-2020-09153. RELATED MANUFACTURER REPORT NUMBER: 2017865-2020-09154. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SIGNIFICANT SWELLING AT THE DEVICE POCKET SITE AND THE INCISION SITE WAS WARM AND REDDENED. UPON OPENING THE POCKET FOR EVACUATION OF HEMATOMA AND EXPLORATION OF THE POCKET, CLOUDY FLUID WAS NOTED INSIDE AND INITIAL LAB CULTURES REVEALED WHITE BLOOD CELLS. THE SYSTEM WAS REMOVED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 10271885 ↗
• MalfunctionJul 18, 2019Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC FOR ROUTINE FOLLOW-UP. UPON DEVICE CHECK, MULTIPLE EPISODES STORED AS NON-SUSTAINED VENTRICULAR OVERSENSING AND NON-SUSTAINED VENTRICULAR TACHYCARDIA DUE TO NOISE ON THE RIGHT VENTRICULAR LEAD WERE NOTED. THE PATIENT WAS IN STABLE CONDITION. NO INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8801274 ↗
• InjuryMar 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED PERICARDIAL TAMPONADE AFTER THE A LEAD REPLACEMENT PROCEDURE. THE PATIENT WAS TREATED AND LATER DISCHARGED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 8466912 ↗
• MalfunctionMar 5, 2019High impedance; High impedance

  NEW INFORMATION NOTES THE PATIENT PRESENTED FOR A ROUTINE CHECK IN CLINIC WITH COMPLAINTS OF DIZZINESS IN HER OWN INTRINSIC RHYTHM. THE COMPLAINT WAS UNCLEAR BUT APPEARED NOT TO BE DEVICE RELATED. DEFIBRILLATION IMPEDANCE WAS INTERMITTENTLY HIGH. THE PHYSICIAN WAS NOTIFIED BUT NO PROGRAMMING CHANGES WERE MADE AND THERE WERE NO PLANS FOR AN INTERVENTION.

  Patient problems: Dizziness; No Known Impact Or Consequence To Patient

  MAUDE report 8389030 ↗
• InjuryNov 26, 2018Failure to Capture; High impedance; High Capture Threshold; Failure to Capture; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT RECEIVED A VIBRATORY NOTIFICATION AND PRESENTED TO THE HOSPITAL. UPON DEVICE INTERROGATION, THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH IMPEDANCE. NO INTERVENTION WAS PERFORMED. THE PATIENT WOULD BE CONTINUED TO BE MONITORED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8104119 ↗

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