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CAPSURE® Z NOVUS 5054-58Recalls & reported problems

Medtronic, Inc. · LEAD 5054-58 CAPSUREZ NOVUS US · Class 3 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169638747), received between Feb 4, 2023 and Feb 4, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Capture” (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

Device problems

  • Failure to Capture1
  • Pacing Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 4, 2023Failure to Capture; Pacing Problem; Failure to Capture; Pacing Problem

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE WITH AND WITHOUT MAGNET ELECTROGRAMS (EGM) WITH POSSIBLE VENTRICULAR SAFETY PACING. THE 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 16301710 ↗

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Sources and updates

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