OPTISURE™ LDP220Q-58Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05414734507448), received between Jan 10, 2019 and Aug 27, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2024High impedance; Low impedance; High impedance; Low impedance

  IT WAS REPORTED THAT A PATIENT PRESENTED REMOTELY WITH INSTANCES OF HIGH AND LOW DEFIBRILLATION IMPEDANCE VALUES WHEN COMPARED TO THE CHRONIC VALUE. NO INTERVENTION OR ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20078928 ↗
• MalfunctionMar 27, 2020Over-Sensing; Over-Sensing

  NEW INFORMATION RECEIVED NOTES THAT POST PACED T-WAVE OVER-SENSING ON THE RIGHT VENTRICULAR (RV) LEAD REOCCURRED. NO INTERVENTION WAS PERFORMED. PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 9892262 ↗
• MalfunctionSep 13, 2019Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR LEAD EXHIBITED NO CAPTURE. PERFORMING A CHEST X-RAY AND LEAD REPLACEMENT WERE DISCUSSED. THE PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9036996 ↗
• InjuryApr 15, 2019Inappropriate/Inadequate Shock/Stimulation; High Capture Threshold; Inappropriate/Inadequate Shock/Stimulation; High Capture Threshold

  IT WAS REPORTED THAT A PATIENT PRESENTED IN THE EMERGENCY ROOM WITH AN IMPLANTABLE CARDIOVERTER DEVICE (ICD) THAT EXHIBITED EPISODES OF INAPPROPRIATE SHOCK AND ANTI TACHYCARDIA PACING (ATP). PATIENT COMPLAINED OF BRIEF SYNCOPE WITH EACH EPISODE. UPON REVIEW OF THE PATIENT'S ELECTROGRAM (EGM), CLINICIAN NOTED THAT THE PATIENT HAD ATRIAL FIBRILLATION (A-FIB) WITH RAPID VENTRICULAR RESPONSE (RVR), OCCASIONALLY WITH ABERRANCY. CLINICIAN WAS UNCLEAR WHETHER THIS WAS VENTRICULAR TACHYCARDIA (VT) OR A-FIB WITH ABERRANCY DUE TO STABLE, REGULAR RHYTHM WITH DIFFERENT MORPHOLOGY. CLINICIAN ALSO NOTED ELEVATED PACING THRESHOLD IN THE RIGHT VENTRICULAR LEAD. PROGRAMMING CHANGES WERE MADE. PATIENT WAS STABLE AFTER PROGRAMMING.

  Patient problems: Shock from Patient Lead(s); Syncope; Therapeutic Effects, Unexpected

  MAUDE report 8516503 ↗
• MalfunctionJan 10, 2019Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT DURING AN IMPLANT, ONE OF THE FINS WAS COMPLETELY DAMAGED ON THE TINED LEAD. THE LEAD WAS NOT USED. THE PATIENT CONDITION IS STABLE..

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8234015 ↗

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