SELECTSECURE™ 383049 (UDI 00643169535848)Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00643169535848), received between Oct 2, 2017 and May 18, 2026 — classified as 28 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (12 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED DUE TO A SYSTEMIC INFECTION WITH BACTEREMIA PRESENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 25211362 ↗
• MalfunctionMay 6, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING. THE LEAD REMAINS IN USE. NO PATIENT C OMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25092369 ↗
• MalfunctionMar 19, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING 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 24638960 ↗
• MalfunctionNov 21, 2025Under-Sensing; Low impedance; Decreased Sensitivity; Under-Sensing; Low impedance; Decreased Sensitivity

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION STORED EPISODES RESULTING IN TERMINATION OF (AT/AF) DETECTED EVENT(S) IN PROGRESS. IT WAS FURTHER REPORTED THAT THE RA LEAD EXHIBITED A LOW UNIPOLAR IMPEDANCE WARNING AND A LOW P WAVE MEASUREMENT. 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 23617056 ↗
• InjuryNov 6, 2025Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

  IT WAS FURTHER REPORTED THAT THE RA LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23486646 ↗
• MalfunctionNov 4, 2025Pacing Problem; Under-Sensing; Pacing 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 AND FALSE TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS ALONG WITH THE LEFT BUNDLE BRANCH RIGHT VENTRICULAR (RV-LBB) LEAD EXHIBITING UNDERSENSING RESULTING IN TERMINATION OF ARRHYTHMIA EVENT IN PROGRESS ON STORED EPIS ODES. BOTH THE RA 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 23461958 ↗
• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; High Capture Threshold; Adverse Event Without Identified Device or Use Problem; High Capture Threshold

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23031108 ↗
• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCREASE IN THRESHOLD, HIGH THRESHOLD AND INTERMITTENT LOSS OF CAPTURE. THE RV LEAD WAS REPROGRAMMED. LATER, WHEN THE PATIENT WENT HOME AND PICKED UP SOMETHING, IT WAS REPORTED THAT THEY FELT SOMETHING IN THEIR ABDOMEN. IT WAS NOTED THAT THE PATIENT HAD A VERY LARGE HEMATOMA WHICH WAS ACTIVELY BLEEDING AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE. BOTH THE RV AND LEFT VENTRICULAR (LV) LEAD WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Tamponade; Hematoma

  MAUDE report 22507886 ↗
• InjuryJul 15, 2025Intermittent Capture; Failure to Capture; Capturing Problem; High Capture Threshold; Intermittent Capture; Failure to Capture; Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCREASE IN THRESHOLD, HIGH THRESHOLD AND INTERMITTENT LOSS OF CAPTURE. THE RV LEAD WAS REPROGRAMMED. LATER, WHEN THE PATIENT WENT HOME AND PICKED UP SOMETHING, IT WAS REPORTED THAT THEY FELT SOMETHING IN THEIR ABDOMEN. IT WAS NOTED THAT THE PATIENT HAD A VERY LARGE HEMATOMA WHICH WAS ACTIVELY BLEEDING AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE. BOTH THE RV AND LEFT VENTRICULAR (LV) LEAD WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Tamponade; Hematoma

  MAUDE report 22507745 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED DUE TO A POCKET INFECTION. EROSION AND FEVER WERE ALSO NOTED. THE CRT-P SYSTEM WAS SUBSEQUENTLY REPLACED SIX DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Fever; Medical device site infection

  MAUDE report 22292396 ↗
• MalfunctionMay 14, 2025Electrical /Electronic Property Problem; Under-Sensing; Electrical /Electronic Property Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED ATRIAL LEAD POSITION CHECK FAILURE. IT WAS ALSO REPORTED THAT THE LEAD EXHIBITED RARE OCCURRENCE OF FUNCTIONAL ATRIAL UNDERSENSING. 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 22017682 ↗
• InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED POCKET INFECTION, EROSION AND FEVER. THE IMPLANTABLE PULSE GENERATOR (IPG) AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Fever; Unspecified Infection

  MAUDE report 20662745 ↗
• MalfunctionOct 18, 2024Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THERE WAS A POSSIBLE LOSS OF CAPTURE NOTED FROM THE RIGHT ATRIAL (RA) LEAD ON THE CURRENT ELECTROGRAMS (EGM). 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 20485508 ↗
• InjuryAug 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19926855 ↗
• InjuryJul 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO AN ENDOCARDITIS INFECTION. A NEW SYSTEM WAS IMPLANTED NINE DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis

  MAUDE report 19806223 ↗
• InjuryJul 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIZZINESS. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DISLODGED. THE RV LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness

  MAUDE report 19687372 ↗
• MalfunctionJul 4, 2024Under-Sensing; Decreased Sensitivity; Under-Sensing; Decreased Sensitivity

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) ON CURR ENT ELECTROGRAMS (EGM). LOW P WAVES MEASURED. 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 19673135 ↗
• InjuryFeb 21, 2024Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

  IT WAS FURTHER REPORTED THAT ELECTROGRAMS (EGM)S APPEAR TO SHOW UPPER RATE BEHAVIOUR.

  Patient problems: Tachycardia

  MAUDE report 18746384 ↗
• InjuryDec 14, 2023Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED EARLY BATTERY DEPLETION. THE RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD THRESHOLDS WERE INCREASED. THE 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 18324347 ↗
• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD ERODED. THE RA LEAD WAS EXPLANTED AND REPLACED DUE TO EROSION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion

  MAUDE report 18037669 ↗
• InjurySep 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING AN ABLATION PROCEDURE, THE RIGHT ATRIAL (RA) LEAD DISLODGED. THE 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 17668105 ↗
• InjuryAug 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT 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 17570341 ↗
• MalfunctionFeb 24, 2023Under-Sensing; Under-Sensing

  IT WAS REPORTED POST-OPERATIVE THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDER-SENSING ON STORED ELECTROGRAMS (EGM). 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 16434516 ↗
• InjuryJan 11, 2023Signal Artifact/Noise; Failure to Capture; Electrical /Electronic Property Problem; Fracture; Under-Sensing; Device Dislodged or Dislocated; Signal Artifact/Noise; Failure to Capture; Electrical /Electronic Property Problem; Fracture; Under-Sensing; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ATRIAL TACHYCARDIA. IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INABILITY TO CONFIRM CAPTURE, NOISE AND NOT SENSING P WAVES APPROPRIATELY. IT WAS ALSO REPORTED THAT THE RA LEAD HAD POSSIBLY DISLODGED AND THAT A POSSIBLE FRACTURE MAY HAVE OCCURRED. THE RA LEAD WAS REPROGRAMMED OFF AND REMAINS IN PATIENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 16136477 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED DUE TO INFECTION. THE ORGANISM WAS IDENTIFIED AS METHICILLIN SENSITIVE STAPH AUREUS. THE IPG SYSTEM WAS EXPLANTED, AND EXISTING LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) RE-ACTIVATED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 15816527 ↗