Capsurefix® Novus 407665Recalls & reported problems
Medtronic, Inc. · LEAD 407665 CAPSFIX NOVUS ACTBI PLY STRT · Class 3 · Implant
All models of CAPSUREFIX NOVUS (17)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994329394), received between Jan 12, 2023 and Jan 12, 2023 — classified as 1 death.
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
- High Capture Threshold1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathJan 12, 2023Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) LEADS EXHIBITED HIGH PACING THRESHOLDS WITH NO EVIDENCE OF CAPTURE. THE PATIENT WAS NOTED TO HAVE EXPIRED IN CLOSE PROXIMITY TO THE REPORT. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT OBTAINED.
Patient problems: Insufficient Information
MAUDE report 16145882 ↗
Other permanent pacemaker Electrode devices
- CapSureFix Novus MRI™ SureScan® 5076-45Medtronic, Inc. · permanent pacemaker Electrode136 deaths16,004 reports
- CapSureFix Novus MRI™ SureScan® 5076-58Medtronic, Inc. · permanent pacemaker Electrode124 deaths8,405 reports
- Capsurefix® Novus 5076-45Medtronic, Inc. · permanent pacemaker Electrode85 deaths7,050 reports
- CapSureFix Novus MRI™ SureScan™ 407652Medtronic, Inc. · permanent pacemaker Electrode69 deaths6,097 reports
- SelectSecure™ MRI SureScan™ 383069Medtronic, Inc. · permanent pacemaker Electrode56 deaths4,850 reports
- Sprint Quattro Secure® 694765Medtronic, Inc. · permanent pacemaker Electrode73 deaths3,852 reports
- Attain Performa™ MRI SureScan™ 429888Medtronic, Inc. · permanent pacemaker Electrode38 deaths3,377 reports
- CapSureFix Novus MRI™ SureScan™ 407645Medtronic, Inc. · permanent pacemaker Electrode38 deaths3,370 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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