OPTISURERecalls & reported problems across all models

We found 11 models of OPTISURE by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 5,124 adverse event reports in the FDA's MAUDE database, received between Jun 11, 2018 and Sep 30, 2026 — classified as 157 deaths, 3,517 injuries, 1,450 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1,151 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported OPTISURE problems

OPTISURE models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• OPTISURE™ LDA210Q-58

  Permanent defibrillator electrodes
  69 deaths2,441 reports
• OPTISURE™ LDA210Q-65

  Permanent defibrillator electrodes
  43 deaths1,706 reports
• OPTISURE™ LDA220Q-58

  Permanent defibrillator electrodes
  19 deaths334 reports
• OPTISURE™ LDA220Q-65

  Permanent defibrillator electrodes
  9 deaths266 reports
• Optisure™ LDA210

  Permanent defibrillator electrodes
  6 deaths147 reports
• OPTISURE™ LDA210Q-52

  Permanent defibrillator electrodes
  4 deaths141 reports
• OPTISURE™ LDA230Q-65

  Permanent defibrillator electrodes
  2 deaths30 reports
• Optisure™ LDA220

  Permanent defibrillator electrodes
  1 death20 reports
• OPTISURE™ LDA220Q-52

  Permanent defibrillator electrodes
  3 deaths19 reports
• OPTISURE™ LDP220Q-65

  Permanent defibrillator electrodes
  1 death15 reports
• OPTISURE™ LDP220Q-58

  Permanent defibrillator electrodes
  5 reports

Recent OPTISURE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Over-Sensing; Capturing Problem; Device Dislodged or Dislocated

  It was reported that the patient presented for a follow up in clinic. It was noted that high capture thresholds, an alert for false ventricular fibrillation (VF) due to oversensing, double counting of P waves and QRS complex were observed on the right ventricular (RV) lead. RV lead dislodgement was suspected. Programming changes were made to address the high capture thresholds. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950619 ↗
• MalfunctionSep 30, 2026Capturing Problem

  It was reported that the patient's Right Ventricular (RV) lead exhibited high capture thresholds. No intervention was performed. The patient was stable throughout.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949624 ↗
• InjurySep 30, 2026Difficult to Fold, Unfold or Collapse; Over-Sensing

  Additional information received indicated that the Right Ventricular (RV) lead exhibited noise oversensing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949246 ↗
• MalfunctionSep 29, 2026Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935407 ↗
• InjurySep 29, 2026Over-Sensing

  It was reported that the patient's Right Ventricular (RV) lead exhibited oversensing, and noise oversensing was suspected. The physician elected to explant the RV lead and replace it with a new lead. The patient's condition was not known.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934510 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented for a follow-up in the clinic with infection at the implanted device pocket site and pocket erosion. The implantable cardioverter defibrillator was visible from the opened incision site of the implanted device pocket. The physician explanted the entire system ¿ implantable cardioverter-defibrillator, right ventricular lead, and atrial lead due to resolve the issue. The patient was in stable condition.

  Patient problems: Unspecified Infection

  MAUDE report 50933689 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the clinic with an infection. The physician explanted the entire pacing system, consisting of the implantable cardioverter-defibrillator (ICD) and right ventricular (RV) lead, and replaced it with a leadless pacemaker on (b)(6) 2026. The patient remained in stable condition.

  Patient problems: Unspecified Infection

  MAUDE report 50928387 ↗
• 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 ↗
• InjurySep 28, 2026Failure to Capture; Fracture; High impedance

  It was reported that the Right Ventricular (RV) lead exhibited loss of capture and high impedance. The RV lead was noted to be fractured. On (b)(6) 2026, the physician capped and replaced the RV lead. The patient was discharged following the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917303 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the hospital with infection and was tested positive for bacteremia. The physician stated that the infection was not caused by Abbotts' devices. The patient's implantable cardioverter-defibrillator, the right atrial lead, the right ventricular lead and the left ventricular lead were explanted due to the infection. The patient was stable throughout.

  Patient problems: Unspecified Infection

  MAUDE report 50910623 ↗
• MalfunctionSep 25, 2026Failure to Sense; Device Sensing Problem

  During an implant procedure, intermittent sensing was observed on the right ventricular (RV) lead. The lead was replaced to resolve the issue. The patient is in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903398 ↗
• InjurySep 25, 2026Failure to Capture; Failure to Sense; Device Dislodged or Dislocated

  It was reported that the patient presented remotely via Merlin.net due to their right ventricular (RV) lead exhibiting a failure to sense. The patient was brought into clinic and it was also noted that there was no capture, and the RV lead had dislodged. The RV lead was explanted and successfully replaced. The patient was discharged.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903143 ↗
• MalfunctionSep 25, 2026Difficult to Fold, Unfold or Collapse; Retraction Problem

  It was reported that during the implant procedure, the lead screw was not extending/retracting properly. The lead was replaced. The patient is in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898839 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented with an infection at the device site. The cause of the infection was unclear. There was no erosion of the device and leads and no vegetation was found on the leads. The gallant, right atrial lead, right ventricular lead and left ventricular lead were explanted. The patient was in stable condition throughout the procedure.

  Patient problems: Unspecified Infection

  MAUDE report 50894238 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the hospital with drainage at the device implant site due to infection. The patient's implantable cardioverter-defibrillator, the right atrial lead and the right ventricular lead were explanted due to the infection. The patient was stable throughout.

  Patient problems: Unspecified Infection

  MAUDE report 50893286 ↗

Other St. Jude Medical, Inc. products

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