SELECTSECURE™ 383059 (UDI 00885074406428)Recalls & reported problems

Summary

The FDA's MAUDE database contains 319 adverse event reports that list this exact device (DI 00885074406428), received between Oct 10, 2014 and Aug 28, 2026 — classified as 4 deaths, 139 injuries, 176 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (138 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 319 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionMay 12, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEFT BUNDLE BRANCH (LBB) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS). THE RA LEAD AND THE RV LBB 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 25147528 ↗
• MalfunctionMay 6, 2026Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING AND INTERMITTENT OVERSENSING ON STORED ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES. 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 25092499 ↗
• InjuryApr 13, 2026Under-Sensing

  IT WAS FURTHER REPORTED THAT THE RA LEAD CONTINUED TO DISPLAY UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENTS IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24867008 ↗
• MalfunctionMar 24, 2026Failure to Capture; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT RIGHT ATRIAL (RA) LEAD CONSISTENT CAPTURE COULD NOT BE CONFIRMED. IT WAS NOTED THAT ATRIAL PACING DEFLECTIONS WERE NOT CONSISTENT AND THAT THE RA LEAD WAS NOT PACING OR SENSING APPROPRIATELY. 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 24673108 ↗
• InjuryMar 13, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A SUSPECTED LOW VOLTAGE FRACTURE. THE LEAD WAS EXPLANTED AND REPLACED. HOWEVER, DURING THE RV LEAD EXPLANT PROCEDURE, THE RIGHT ATRIAL (RA) LEAD HAD DISLODGED SO THAT LEAD WAS ALSO 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 24595616 ↗
• MalfunctionMar 11, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING ON A STORED ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODE, RESULTING IN UNNECESSARY PACING AT TIMES AND TERMINATION OF THE AT/AF DETECTED EVENT 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 24575887 ↗
• MalfunctionMar 6, 2026Under-Sensing

  IT WAS REPORTED THAT THE HIS BUNDLE LEAD EXHIBITED UNDER SENSING AND/OR BLANKING OF VENTRICULAR ACTIVITY AND SENSING OF ATRIAL ACTIVITY WITH FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) DETECTED EVENT(S) IN PROGRESS. IT WAS ALSO REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) DISPLAYED DIAGNOSTIC RESET. THE HIS BUNDLE LEAD AND THE IPG 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 24529489 ↗
• MalfunctionFeb 17, 2026Degraded

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND THE RIGHT VENTRICULAR (RV) LEAD WERE RETURNED FOR AN UNKNOWN LEAD REASON, ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24363517 ↗
• InjuryJan 30, 2026Fracture

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED SUSPECTED FRACTURES. THE LEADS WERE EX PLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24220976 ↗
• InjuryJan 30, 2026Fracture

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED SUSPECTED FRACTURES. THE LEADS WERE EX PLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24220974 ↗
• MalfunctionJan 26, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS RESULTING IN UNNECESSARY PACING AT TIMES. 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 24179849 ↗
• MalfunctionJan 20, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA (AT) / ATRIAL FIBRILLATION (AF) EVENTS RESULTING IN UNNECESSARY PACING AT TIMES AND IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS. IT WAS FURTHER REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED POSSIBLE LOSS OF CAPTURE. THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTEDAS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24117688 ↗
• MalfunctionJan 15, 2026Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR SENSING INTEGRITY COUNTER (SIC) AND IMPEDANCE VARIATION. IT WAS FURTHER REPORTED THAT THE RV LEAD EXHIBITED UNDEFINED OUT OF RANGE (OOR) HIGH TIP TO COIL PACING IMPEDANCE, AND OUT OF RANGE (OOR) LOW BIPOLAR PACING IMPEDANCE. IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OUT OF RANGE (OOR) LOW BIPOLAR PACING IMPEDANCE. 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 24085006 ↗
• MalfunctionDec 19, 2025Under-Sensing; Under-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 EVENT(S) 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 23848119 ↗
• MalfunctionDec 11, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THERE WAS HIGH THRESHOLD ON THE RIGHT ATRIAL (RA) LEAD. 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 23777171 ↗
• MalfunctionNov 26, 2025High impedance; Over-Sensing; High Capture Threshold; High impedance; Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED A WARNING FOR OUT OF RANGE HIGH IMPEDANCE AND HIGH THRESHOLDS. FAR FIELD R-WAVE (FFRW) OVERSENSING WAS ALSO NOTED ON STORED EPISODES. THE RA LEAD IS STILL IN USE. IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED AN ALERT FOR HIGH IMPEDANCE. THE LV LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659578 ↗
• MalfunctionNov 21, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING ON STORED ELECTROGRAMS (EGM) RESULTING IN MISCLASSIFICATION OF NON SUSTAINED VENTRICULAR TACHYCARDIA (VT-NS) EPISODE. 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 23615951 ↗
• InjuryNov 5, 2025High Capture Threshold; High Capture Threshold

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23475917 ↗
• MalfunctionOct 24, 2025Corroded; Corroded

  THE LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23379872 ↗
• MalfunctionSep 15, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING ON THE ELECTROGRAMS (EGM). 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 23052244 ↗