CapSureFix Novus MRI™ SureScan® 5076-85 (UDI 00643169448926)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169448926), received between Dec 9, 2016 and Oct 27, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2022Connection Problem; Connection Problem

  THE PATIENT REPORTED THAT, APPROXIMATELY THREE MONTHS POST GENERATOR AND EPICARDIAL LEFT VENTRICULAR (LV) LEAD CHANGEOUT, THEY EXPERIENCED, "TOO MUCH," SCAR TISSUE FORMED DUE TO, "SO MANY," SURGERIES AND INTERFERED WITH THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM CONNECTIVITY. THE IPG SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Scar Tissue

  MAUDE report 15678696 ↗
• MalfunctionDec 9, 2016Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS ATTEMPTED, NOT IMPLANTED. THE PHYSICIAN HAD TROUBLE MANEUVERING THE LEAD, ADVANCING STYLETS, AND PLACING THE LEAD APPROPRIATELY. DUE TO THE LEAD NOT BEING COMMON LENGTH NO ADDITIONAL STYLETS WERE AVAILABLE TO ASSIST IN FURTHER ATTEMPTS TO PLACE THE LEAD. A NEW LENGTH OF LEAD WAS IMPLANTED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6164536 ↗