CAPSURE®SP NOVUS 5592-53 (UDI 00643169590731)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169590731), received between Aug 20, 2019 and Sep 18, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Signal Artifact/Noise

  It was reported that the Right Atrial (RA) lead exhibited noise. 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 50815245 ↗
• InjuryNov 3, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS FURTHER REPORTED THAT THE RA AND RV LEADS WERE CUT DUE TO THE PHYSICIAN'S JUDGEMENT TO FACILITATE THE VALVE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10779447 ↗
• InjuryAug 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED DUE TO INFECTION AND THE PACING SYSTEM REPLACED WITH A LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8910665 ↗