CapSureFix Novus MRI™ SureScan™ 407685Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169708228), received between Apr 10, 2018 and Jul 13, 2023 — 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.

• MalfunctionJul 13, 2023Under-Sensing; Positioning Problem; High Capture Threshold; Under-Sensing; Positioning Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS PULLED BACK AND EXHIBITED HIGH THRESHOLDS AND NO SENSING. 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 17315527 ↗
• InjuryMay 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED DUE TO EROSION AND SUSPECTED INFECTION. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND WILL RECEIVE A NEW SYSTEM AT A FUTURE DATE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 10028145 ↗
• InjuryJun 20, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT BOTH THE ATRIAL AND RIGHT VENTRICULAR (RV) LEADS DISLODGED OVER TIME. IT WAS NOTED THAT THE PATIENT WAS (B)(6) TALL, WHICH MAY HAVE PLACED ADDITIONAL STRAIN ON THE LEADS. BOTH LEADS WERE 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 7622306 ↗
• InjuryApr 10, 2018Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED NERVE AND DIAPHRAGMATIC STIMULATION. THE RIGHT ATRIAL (RA) LEAD HAD DISLODGED AND WAS FOUND IN THE SUPERIOR VENA CAVA (SVC). THE RV LEAD HAD ALSO DISLODGED AND WAS FOUND IN THE RIGHT ATRIUM. BOTH LEADS WERE REPOSITIONED AND REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Muscle Stimulation; Undesired Nerve Stimulation

  MAUDE report 7418377 ↗