SELECTSECURERecalls & reported problems across all models

We found 12 models of SELECTSECURE by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 1,086 adverse event reports in the FDA's MAUDE database, received between Oct 10, 2014 and Sep 28, 2026 — classified as 13 deaths, 645 injuries, 428 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (328 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 SELECTSECURE problems

SELECTSECURE models

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

• SELECTSECURE™ 383059

  permanent pacemaker Electrode
  4 deaths319 reports
• SELECTSECURE™ 383069

  permanent pacemaker Electrode
  1 death318 reports
• SELECTSECURE™ 383069

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  4 deaths128 reports
• Selectsecure™ 383069

  permanent pacemaker Electrode
  1 death100 reports
• Selectsecure™ 383059

  Permanent defibrillator electrodes
  86 reports
• SELECTSECURE™ 383059

  Permanent defibrillator electrodes
  2 deaths71 reports
• SELECTSECURE™ 383049

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  45 reports
• Selectsecure™ 383049

  permanent pacemaker Electrode
  6 reports
• SELECTSECURE™ 383074

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  1 death6 reports
• SelectSecure™ 383074

  Permanent defibrillator electrodes
  3 reports
• Selectsecure™ 383049

  permanent pacemaker Electrode
  2 reports
• Selectsecure™ 383074

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  2 reports

Recent SELECTSECURE adverse event reports

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

• InjurySep 28, 2026Failure to Capture

  It was reported that there was no capture on the Right Atrial (RA) lead. The RA lead was explanted. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50912209 ↗
• InjurySep 15, 2026Fracture; High impedance

  It was reported that the Right Ventricular (RV) lead exhibited high and undefined impedance warnings and had fractured. The RV lead was programmed "off" and 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 50774398 ↗
• MalfunctionSep 1, 2026Pacing Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50539527 ↗
• MalfunctionAug 28, 2026Signal Artifact/Noise; Pacing Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50499599 ↗
• MalfunctionAug 28, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50493949 ↗
• MalfunctionAug 26, 2026Pacing Problem; Under-Sensing

  It was reported that the Right Atrial (RA) lead exhibited under sensing resulting in misclassification of episode type, unnecessary pacing at times and termination of Atrial Tachycardia (AT)/Atrial Fibrillation (AF) detected event(s) in progress. It was reported that the Right Ventricular (RV) lead exhibited under sensing resulting in over pacing. It was reported that the RV lead was under sensing in blanking, resulting in over pacing. The Implantable Pulse Generator (IPG) system 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 50450908 ↗
• MalfunctionAug 26, 2026Pacing Problem; Under-Sensing

  It was reported that the Right Atrial (RA) lead exhibited under sensing resulting in misclassification of episode type, unnecessary pacing at times and termination of Atrial Tachycardia (AT)/Atrial Fibrillation (AF) detected event(s) in progress. It was reported that the Right Ventricular (RV) lead exhibited under sensing resulting in over pacing. It was reported that the RV lead was under sensing in blanking, resulting in over pacing. The Implantable Pulse Generator (IPG) system 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 50450814 ↗
• InjuryJul 30, 2026Capturing Problem

  It was reported that the Right Ventricular (RV) lead exhibited rising thresholds. The RV lead was inactivated and replaced. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50085984 ↗
• InjuryJul 14, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE RV LEAD WAS REMOVED AND REPLACED. NO PATIENT COM PLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25812143 ↗
• InjuryJul 13, 2026Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A FRACTURE. THE RV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25792940 ↗
• InjuryJul 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25714025 ↗
• InjuryJul 3, 2026Intermittent Capture; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) HIS BUNDLE LEAD EXHIBITED HIGH THRESHOLDS AND INTERMITTENT CAPTURE. IT WAS NOTED THAT THE HIS BUNDLE LEAD WAS REPOSITIONED TO THE LEFT VENTRICULAR (LV) PORT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25702171 ↗
• DeathJun 29, 2026Failure to Capture; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD BOTH EXHIBITED NO CAPTURE. THE RIGHT VENTRICULAR (RV) LEAD ALSO EXHIBITED HIGH THRESHOLDS AND A RISE IN IMPEDANCE. BOTH LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25649214 ↗
• MalfunctionJun 24, 2026Under-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND UNDER SENSING. THE 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 25608817 ↗
• MalfunctionJun 10, 2026Under-Sensing

  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. IT WAS ALSO NOTED THAT THERE WERE LOW P-WAVES. 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 25456166 ↗

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