CAPSUREFIX® NOVUS 407652 (UDI 00885074200682)Recalls & reported problems
Medtronic, Inc. · LEAD 407652 CAPSUREFIX NOVUS PACE US · Class 3 · Implant
Quick summary
This Medtronic CapSureFix Novus pacing lead is an electrode that carries signals between a pacemaker and the heart. Its 2,859 reports mostly describe the lead misreading heart signals, either missing real beats or picking up noise, and some describe the lead needing more energy to pace the heart. The reports also mention 40 deaths and 1,206 injuries, and 1,613 malfunctions are recorded. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 2,876
- Deaths reported
- 40
- Injuries reported
- 1,215
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,876 adverse event reports that list this exact device (DI 00885074200682), received between Oct 10, 2013 and Sep 30, 2026 — classified as 40 deaths, 1,215 injuries, 1,621 malfunctions.
The most frequently reported specific device problem is “Under-Sensing” (1,078 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Under-Sensing1,078
- Over-Sensing473
- Adverse Event Without Identified Device or Use Problem471
- High Capture Threshold419
- High impedance265
- Failure to Capture189
- Pacing Problem149
- Impedance Problem134
Patient problems
- No Clinical Signs, Symptoms or Conditions1,295
- No Known Impact Or Consequence To Patient695
- Unspecified Infection365
- No Consequences Or Impact To Patient115
- Dyspnea56
- Chest Pain47
- Erosion44
- Bradycardia38
Recent adverse event reports
The 25 most recent of 2,876 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Capture
It was reported that the Right Ventricular (RV) lead exhibited loss of capture. 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 50943371 ↗MalfunctionSep 30, 2026Pacing Problem; Under-Sensing
It was reported that the Right Ventricular (RV) lead exhibited undersensing resulting in inappropriate pacing. The lead remains in u se. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943079 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted due to an infection resulting in discomfort, erosion, redness, swelling and wound dehiscence. No further patient complications have been reported as a result of this event.
Patient problems: Discomfort; Erosion; Erythema; Swelling/ Edema; Unspecified Infection; Wound Dehiscence
MAUDE report 50934445 ↗MalfunctionSep 28, 2026Pacing Problem; Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923756 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Medical device site infection
MAUDE report 50916057 ↗MalfunctionSep 28, 2026Over-Sensing
It was reported that the Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing on stored episodes. 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 50915459 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Implantable Cardioverter Defibrillator (ICD) patient experienced an infection. The device system was explanted and replaced. No further patient complications have been reported as a result of this event.
Patient problems: Unspecified Infection
MAUDE report 50897438 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced an infection. The organism was identified as Enterococcus faecalis. It was further noted that the patient experienced bacteremia and discomfort. The patient was administered antibiotics. The IPG system was explanted. No further patient complications have been reported as a result of this event.
Patient problems: Bacteremia; Discomfort
MAUDE report 50882074 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
It was reported that shortly after the Cardiac Resynchronization Therapy Defibrillator (CRT-D) implant, the patient experienced a large hematoma on the left side for which incision and drainage was performed on the left side. It was suspected that subsequently the patient developed infection with weakness, bacteremia, erosion and organism identified as Methicillin sensitive staphylococcus aureus (MSSA). The CRT-D system was explanted. No further patient complications have been reported as a result of this event.
Patient problems: Bacteremia; Bacterial Infection; Erosion; Muscle Weakness/Atrophy
MAUDE report 50869926 ↗MalfunctionSep 15, 2026Signal Artifact/Noise; Failure to Capture; Over-Sensing; Pacing Problem; Decreased Sensitivity; High Capture Threshold
It was reported that the Right Atrial (RA) lead exhibited high thresholds, a decline in P waves, possible non capture with P-waves p resent and unnecessary mode switching resulting in ventricular pacing not tracking P-waves, Far Field R-Wave (FFRW) oversensing triggering Atrial Tachycardia/Atrial Fibrillation (AT/AF) episode misclassification and noise. The Right Ventricular (RV) lead was also noted to exhibit noise. The RA lead and RV lead remain in use. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50774280 ↗MalfunctionSep 15, 2026Under-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. An abrupt drop of P wave was noted during this session. It was further reported that there was an RV tip to RV coil impedance warning. The RA lead and the RV lead remain in use. No patient complications have been reported as a result of this event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50766629 ↗MalfunctionSep 14, 2026High Capture Threshold
It was reported that the Right Ventricular (RV) lead exhibited high thresholds. 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 50753528 ↗MalfunctionSep 9, 2026Over-Sensing
It was reported that the Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing triggering false Atrial Tachycardia/Atrial Fibrillation (AT/AF) detections. 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 50691383 ↗MalfunctionSep 8, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50670120 ↗MalfunctionSep 4, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50612516 ↗InjurySep 4, 2026High Capture Threshold
It was reported that the Right Atrial (RA) lead exhibited high thresholds. The lead was capped and replaced. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50611446 ↗MalfunctionSep 4, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50607013 ↗MalfunctionAug 31, 2026Pacing Problem; Under-Sensing
It was reported that the patient experienced shortness of breath. It was also reported that the Right Ventricular (RV) lead exhibited under-sensing resulting in inappropriate pacing. The RV lead remains in use. No further patient complications have been reported as a result of this event..
Patient problems: Dyspnea
MAUDE report 50517561 ↗MalfunctionAug 27, 2026Signal Artifact/Noise; Over-Sensing; Under-Sensing
It was reported that the Right Atrial (RA) lead exhibited noise, Far Field R-Wave (FFRW) oversensing, and oversensing resulting in m isclassification of episode type. The RA lead displayed undersensing on during Atrial Tachycardia/Atrial Fibrillation (AT/AF) stored episodes resulting in termination of AT/AF detected event(s) in progress. 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 50485144 ↗MalfunctionAug 27, 2026Over-Sensing
It was reported that the Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing. 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 50484017 ↗MalfunctionAug 26, 2026Signal Artifact/Noise; Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50457641 ↗MalfunctionAug 26, 2026Low impedance
It was reported that the Implantable Pulse Generator (IPG) exhibited a false low impedance warning and the Right Atrial (RA) lead exhibited a warning for low impedance. The IPG and RA lead remain in use. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50447807 ↗MalfunctionAug 20, 2026Decreased Sensitivity; Impedance Problem
It was reported that the Right Ventricular (RV) lead exhibited rising impedance and diminished sensing. 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 50344046 ↗MalfunctionAug 19, 2026Over-Sensing; Pacing Problem; Under-Sensing
It was reported that the Right Ventricular (RV) lead exhibited undersensing and oversensing resulting in underpacing and overpacing. 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 50325404 ↗MalfunctionAug 19, 2026Pacing Problem; Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50320387 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.