SelectSecure™ MRI SureScan™ 383059 (UDI 00763000740252)Recalls & reported problems

Summary

The FDA's MAUDE database contains 450 adverse event reports that list this exact device (DI 00763000740252), received between Jun 19, 2023 and Sep 30, 2026 — classified as 3 deaths, 222 injuries, 225 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (161 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, 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 450 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced a medical device site infection, discomfort, purulent discharge and bacteremia. The Imp lantable Pulse Generator (IPG) system was explanted. No further patient complications have been reported as a result of this event.

  Patient problems: Discomfort; Drug Resistant Bacterial Infection; Medical device site infection; Purulent Discharge

  MAUDE report 50944300 ↗
• MalfunctionSep 30, 2026Under-Sensing

  It was reported approximately one month post implant that the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) stored episodes resulting in termination of AT/AF detected event(s) in progress. The RA lead remains in use. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942783 ↗
• MalfunctionSep 28, 2026Signal Artifact/Noise; High impedance; Over-Sensing; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926274 ↗
• MalfunctionSep 24, 2026Electrical /Electronic Property Problem; Device Dislodged or Dislocated

  It was reported that post-operatively the Right Atrial (RA) lead became dislodged and dropped into the ventricle. It was also noted that the lead failed an Atrial Lead Position Check (ALPC). The lead remains in the patient. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883431 ↗
• MalfunctionSep 24, 2026High Capture Threshold

  It was reported that the Right Atrial (RA) lead exhibited high thresholds. The lead remains in use. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50881717 ↗
• MalfunctionSep 23, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872900 ↗
• MalfunctionSep 17, 2026High Capture Threshold

  It was reported that the Right Atrial (RA) lead exhibited high threshold and patient was symptomatic. The RA lead remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Insufficient Information

  MAUDE report 50802267 ↗
• MalfunctionSep 16, 2026Signal Artifact/Noise; Failure to Capture; High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793709 ↗
• MalfunctionSep 15, 2026Over-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited under-sensing resulting in inappropriate pacing. It was also reported that the Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing triggering false Atrial Tachycardia/Atrial Fibrillation (AT/AF) detections. The RA lead and RV lead remains in use. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50771211 ↗
• MalfunctionSep 11, 2026Under-Sensing; High Capture Threshold

  It was reported that the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) stored episodes resulting in termination of AT/AF detected events in progress, and high capture thresholds. The lead remains in use. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50733644 ↗
• MalfunctionSep 10, 2026Under-Sensing

  It was reported that the Right Atrial (RA) lead exhibited intermittent undersensing and undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) stored episodes resulting in termination of AT/AF detected events in progress. The lead remains in use. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50717714 ↗
• MalfunctionSep 10, 2026Signal Artifact/Noise; Decreased Sensitivity; Device Dislodged or Dislocated; Impedance Problem

  It was reported that three days post implant the Right Atrial (RA) lead exhibited noise, a slight drop in impedance and sensing. The RA lead was suspected to have dislodged. The RA lead remains in use. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713250 ↗
• DeathSep 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient expired approximately two months post-implant. The cause of death was provided as starvation ketosis in the setting of esophageal dysmotility with extensive tertiary/contractions. The disposition of the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system remains unknown.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50676233 ↗
• MalfunctionSep 8, 2026Over-Sensing

  It was reported that the Left Bundle Branch Area Pacing (LBBAP) lead exhibited T-Wave Oversensing (TWOS), and the Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing. The leads remain in use. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50669893 ↗
• InjurySep 8, 2026Device Dislodged or Dislocated

  It was reported that the patient experienced bradycardia and twiddlers syndrome. It was further reported that the Right Atrial (RA) lead and the Right Ventricular (RV) lead dislodged. Both leads were explanted and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Bradycardia; Twiddlers Syndrome

  MAUDE report 50666760 ↗
• MalfunctionSep 7, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50648836 ↗
• MalfunctionSep 6, 2026Pacing Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50638151 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced an infection and discomfort. The Implantable Pulse Generator (IPG) system was explanted. No further patient complications have been reported as a result of this event.

  Patient problems: Discomfort; Unspecified Infection

  MAUDE report 50609540 ↗
• MalfunctionSep 4, 2026Pacing Problem; Under-Sensing

  It was reported that the Right Atrial (RA) lead exhibited under sensing during Atrial Tachycardia (AT)/Atrial Fibrillation (AF) events resulting in unnecessary pacing at times and resulting in termination of AT/AF detected event(s) in progress. The RA lead remains in use. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50606211 ↗
• InjurySep 2, 2026High Capture Threshold

  It was reported that the Right Atrial (RA) lead exhibited high thresholds. The RA lead was reprogrammed and remains in use. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50563330 ↗
• MalfunctionSep 2, 2026Electrical /Electronic Property Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50560838 ↗
• InjuryAug 28, 2026Failure to Capture

  It was reported that Right Ventricular (RV) - Left Bundle Branch (LBB) lead exhibited non-capture. The RV-LBB lead was explanted and replaced. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50495770 ↗
• InjuryAug 28, 2026Device Dislodged or Dislocated

  It was reported approximately one month post implant that the Right Atrial (RA) lead exhibited a dislodgement, and X-ray confirmed it was in the Right Ventricle. The RA lead was explanted and replaced. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50493024 ↗
• MalfunctionAug 27, 2026Over-Sensing; Connection Problem

  It was reported that the clinician noted an issue with over-sensing in the patient's defibrillator.  A review of device data indicated what appears to be possible Electromagnetic Interference source or lead/device connection issue as device was implanted less than a month prior.   The Implantable Cardioverter Defibrillator (ICD), Right Atrial (RA) lead and Right Ventricular (RV) lead remain in use.  No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50483104 ↗
• InjuryAug 27, 2026Device Dislodged or Dislocated

  It was reported that approximately three weeks post implant the Right Atrial (RA) lead had dislodged. The RA lead was explanted and replaced. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50470808 ↗