CapSureFix Novus MRI SureScanRecalls & reported problems across all models
Medtronic, Inc. · 29 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 87,337
- Deaths reported
- 943
- Injuries reported
- 40,711
- Recalls
- 0
We found 29 models of CapSureFix Novus MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 87,337 adverse event reports in the FDA's MAUDE database, received between Jun 10, 2015 and Sep 30, 2026 — classified as 943 deaths, 40,711 injuries, 45,682 malfunctions.
The most frequently reported specific device problem is “Under-Sensing” (28,680 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported CapSureFix Novus MRI SureScan problems
Device problems
- Under-Sensing28,680
- Adverse Event Without Identified Device or Use Problem15,494
- Over-Sensing14,199
- Device Dislodged or Dislocated11,428
- High Capture Threshold10,515
- Pacing Problem6,198
- Failure to Capture6,008
- High impedance5,016
Patient problems
- No Clinical Signs, Symptoms or Conditions47,465
- No Known Impact Or Consequence To Patient12,648
- Unspecified Infection9,682
- No Consequences Or Impact To Patient2,481
- Chest Pain1,932
- Cardiac Perforation1,526
- Dyspnea1,510
- Dizziness1,327
CapSureFix Novus MRI SureScan models
29 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CapSureFix Novus MRI™ SureScan® 5076-52Permanent defibrillator electrodes333 deaths30,581 reports
- CapSureFix Novus MRI™ SureScan® 5076-45permanent pacemaker Electrode136 deaths16,004 reports
- CapSureFix Novus MRI™ SureScan® 5076-58permanent pacemaker Electrode124 deaths8,405 reports
- CapSureFix Novus MRI™ SureScan® 5076-52Permanent defibrillator electrodes80 deaths8,280 reports
- CapSureFix Novus MRI™ SureScan™ 407652permanent pacemaker Electrode69 deaths6,097 reports
- CapSureFix Novus MRI™ SureScan® 5076-45Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes40 deaths5,000 reports
- CapSureFix Novus MRI™ SureScan™ 407645permanent pacemaker Electrode38 deaths3,370 reports
- CapSureFix Novus MRI™ SureScan® 5076-58permanent pacemaker Electrode40 deaths3,015 reports
- CapSureFix Novus MRI™ SureScan® 5076-52Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes16 deaths2,051 reports
- CapSureFix Novus MRI™ SureScan™ 407658Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes33 deaths1,539 reports
- CapSureFix Novus MRI™ SureScan® 5076-45Permanent defibrillator electrodes9 deaths1,251 reports
- CapSureFix Novus MRI™ SureScan® 5076-58Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes6 deaths698 reports
- CapSureFix Novus MRI™ SureScan™ 5076-52Permanent defibrillator electrodes5 deaths329 reports
- CapSureFix Novus MRI™ SureScan™ 5076-45Permanent defibrillator electrodes2 deaths232 reports
- CapSureFix Novus MRI™ SureScan® 5076-65Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes3 deaths148 reports
- CapSureFix Novus MRI™ SureScan™ 5076-58Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes3 deaths99 reports
- CapSureFix Novus MRI™ SureScan® 5076-65Permanent defibrillator electrodes66 reports
- CapSureFix Novus MRI™ SureScan™ 407645Permanent defibrillator electrodes2 deaths48 reports
- CapSureFix Novus MRI™ SureScan™ 407652permanent pacemaker Electrode2 deaths27 reports
- CapSureFix Novus MRI™ SureScan™ 407665Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes18 reports
- CapSureFix Novus MRI™ SureScan® 5076-35Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes15 reports
- CapSureFix Novus MRI™ SureScan™ 407658Permanent defibrillator electrodes15 reports
- CapSureFix Novus MRI™ SureScan® 5076-85Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes1 death13 reports
- CapSureFix Novus MRI™ SureScan® 5076-65Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes11 reports
- CapSureFix Novus MRI™ SureScan® 5076-35permanent pacemaker Electrode9 reports
- CapSureFix Novus MRI™ SureScan® 5076-35permanent pacemaker Electrode5 reports
- CapSureFix Novus MRI™ SureScan® 5076-85permanent pacemaker Electrode1 death5 reports
- CapSureFix Novus MRI™ SureScan™ 407685Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes4 reports
- CapSureFix Novus MRI™ SureScan® 5076-85Permanent defibrillator electrodes2 reports
Recent CapSureFix Novus MRI SureScan adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection; Wound Dehiscence
MAUDE report 50955129 ↗MalfunctionSep 30, 2026Over-Sensing; Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954489 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Endocarditis; Unspecified Infection
MAUDE report 50953665 ↗InjurySep 30, 2026Over-Sensing; Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951856 ↗MalfunctionSep 30, 2026Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951603 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Bacteremia; Unspecified Infection
MAUDE report 50951241 ↗MalfunctionSep 30, 2026Pacing Problem; Under-Sensing
Patient problems: Dyspnea
MAUDE report 50950832 ↗MalfunctionSep 30, 2026Capturing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950790 ↗MalfunctionSep 30, 2026High impedance; Unstable Impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950632 ↗MalfunctionSep 30, 2026Pacing Problem; Under-Sensing; Low impedance; Decreased Sensitivity
It was reported that the Right Atrial (RA) lead exhibited undersensing on current electrograms (EGM) and stored episode(s) during Atrial Tachycardia/Atrial Fibrillation (AT/AF) events resulting in unnecessary pacing at times and termination of AT/AF detected event(s) in progress. Low P waves were also noted. The 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 50950503 ↗InjurySep 30, 2026Capturing Problem
Patient problems: Bradycardia; Syncope/Fainting
MAUDE report 50949997 ↗MalfunctionSep 30, 2026Pacing Problem; Under-Sensing; Decreased Sensitivity
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949438 ↗MalfunctionSep 30, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949362 ↗MalfunctionSep 30, 2026Pacing Problem; Under-Sensing
It was reported that the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) stored episodes resulting in termination of AT/AF detected events in progress, unnecessary atrial pacing during AT/AF events, and misclassification of Atrial Fibrillation (AF)-Supra Ventricular Tachycardia (SVT) episode. 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 50948666 ↗MalfunctionSep 30, 2026Electrical /Electronic Property Problem; Under-Sensing
It was reported that during use of the Cardiac Resynchronization Therapy Defibrillator (CRT-D), the Ventricular Tachycardia (VT) rhythm appears to fall in and out of detection possibly delaying therapy. At device classified termination of events, arrhythmia appears to continue beneath detection rate. The CRT-D remains in use. The Right Atrial (RA) lead, atrial lead position check failed due to an unknown/unspecified reason. It was further reported that another RA lead Atrial Lead Position Check failed and it was due to intermittent and sudden undersensing. The lead remains in use with the physician closely monitoring lead trends. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948182 ↗
Other Medtronic, Inc. products
- Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
- Intellis AdaptiveStim3 models · 35,469 reports
- SYNCHROMED II11 models · 32,260 reports · 4 recalls
- CAPSUREFIX NOVUS17 models · 27,547 reports
- INTERSTIM30 models · 24,415 reports · 1 recall
- Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
- Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls
- Medtronic Azure Pacemaker12 models · 16,566 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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