Selectsecure™ 383049 (UDI 00643169279186)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169279186), received between Jan 23, 2019 and Sep 28, 2026 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Capture” (3 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 6 most recent of 6 reports, 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 ↗
• InjuryAug 13, 2024Low impedance; High Capture Threshold; Low impedance; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED A LEAD WARNING FOR LOW IMPEDANCE AND HIGH THRESHOLDS RESULTING IN PREMATURE BATTERY DEPLETION OF THE IMPLANTABLE PULSE GENERATOR (IPG). THE RA LEAD WAS CAPPED AND REPLACED AND THE IPG WAS INITIALLY REPROGRAMMED AND THEN 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 19975567 ↗
• InjuryAug 6, 2020Failure to Capture; Under-Sensing; High Capture Threshold; Failure to Capture; Under-Sensing; High Capture Threshold

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10372384 ↗
• MalfunctionDec 23, 2019Failure to Capture; Failure to Capture

  IT WAS FURTHER REPORTED THAT THE LEAD WAS A HIS LEAD.

  Patient problems: Palpitations

  MAUDE report 9509598 ↗
• InjuryMay 13, 2019Under-Sensing; Decreased Sensitivity; Under-Sensing; Decreased Sensitivity

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING AND VERY SMALL P-WAVES. THE RA LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8604166 ↗
• MalfunctionJan 23, 2019Break; Over-Sensing; Pacing Problem; High Capture Threshold; Break; Over-Sensing; Pacing Problem; High Capture Threshold

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8271052 ↗