CAPSURE® Z NOVUS 5554-45Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169638785), received between Aug 9, 2017 and Feb 20, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS FRACTURED. DURING THE LEAD EXTRACTION PROCEDURE, PURULENT DRAINAGE WAS OBSERVED FROM THE POCKET. THE RA LEAD AND THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Purulent Discharge

  MAUDE report 18737464 ↗
• MalfunctionFeb 6, 2024Pacing 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) RESULTING IN INAPPROPRIATE PACING. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18649006 ↗
• InjurySep 8, 2022Failure to Capture; High impedance; Device Dislodged or Dislocated; High Capture Threshold; Failure to Capture; High impedance; Device Dislodged or Dislocated; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS EXHIBITING HIGH AND UNDEFINED IMPEDANCE AND NO CAPTURE AT HIGH OUTPUT. HIGH THRESHOLDS WERE ALSO NOTED ON THE RA LEAD. 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 15377575 ↗
• InjuryAug 9, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD DISLODGED SHORTLY AFTER IMPLANT. THE LEAD WAS EXPLANTED 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 6780985 ↗