CAPSUREFIX® NOVUS 407645 (UDI 00885074200675)Recalls & reported problems
Medtronic, Inc. · LEAD 407645 CAPSUREFIX NOVUS PACE US · Class 3 · Implant
Quick summary
This Medtronic CapsureFix Novus pacing lead is a wire that carries pacemaker signals to the heart. Of its 1,699 reports, most describe the lead failing to detect the heart's own beats or reading noise as heartbeats, and some describe pulses failing to make the heart beat. The reports include 12 deaths and 558 injuries, and some mention infection, chest pain and shortness of breath. 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
- 1,708
- Deaths reported
- 12
- Injuries reported
- 561
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,708 adverse event reports that list this exact device (DI 00885074200675), received between Feb 9, 2016 and Sep 30, 2026 — classified as 12 deaths, 561 injuries, 1,135 malfunctions.
The most frequently reported specific device problem is “Under-Sensing” (863 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-Sensing863
- Over-Sensing283
- Adverse Event Without Identified Device or Use Problem214
- High Capture Threshold174
- Pacing Problem97
- Failure to Capture78
- High impedance73
- Device Dislodged or Dislocated66
Patient problems
- No Clinical Signs, Symptoms or Conditions840
- No Known Impact Or Consequence To Patient449
- Unspecified Infection161
- No Consequences Or Impact To Patient76
- Chest Pain22
- Dyspnea22
- Sepsis18
- Dizziness16
Recent adverse event reports
The 25 most recent of 1,708 reports, 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
MAUDE report 50954560 ↗InjurySep 30, 2026High Capture Threshold
It was reported that the Right Atrial (RA) lead exhibited high thresholds. The RA lead was capped and replaced. No patient complicat ions have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946359 ↗MalfunctionSep 30, 2026High impedance
It was reported that the Right Atrial (RA) lead exhibited high impedance. 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 50943032 ↗MalfunctionSep 30, 2026Electrical /Electronic Property Problem; Under-Sensing
It was reported that the Right Atrial (RA) lead exhibited undersensing triggering device classified false termination of Atrial Tachycardia/Atrial Fibrillation (AT/AF) event(s) at times and a Atrial Lead Position Check failure. 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 50942892 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Erythema; Medical device site infection; Swelling/ Edema
MAUDE report 50903306 ↗MalfunctionSep 25, 2026Electrical /Electronic Property 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 event(s) in progress. It was also reported position check failed. 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 50895169 ↗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 50882147 ↗MalfunctionSep 11, 2026Pacing Problem; Under-Sensing
It was reported that the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) events resulting in unnecessary pacing at times and misclassification of episode type. The Implantable Cardioverter Defibrillator (ICD) de livered Anti-Tachycardia Pacing (ATP) and shocks for AT/AF with Rapid Ventricular Response (RVR) that was detected as Ventricular Tachycardia (VT). The ICD and lead remains in use. No further patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50733926 ↗MalfunctionSep 9, 2026High impedance; Pacing Problem; Under-Sensing
It was reported that the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) episodes at time and resulted in inappropriate pacing. The RA lead also exhibited high impedance. 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 50685999 ↗MalfunctionSep 2, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50566862 ↗MalfunctionSep 1, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50546041 ↗MalfunctionAug 20, 2026Under-Sensing
Patient problems: Chest Pain
MAUDE report 50356593 ↗InjuryAug 19, 2026Over-Sensing
It was reported that the Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing. The lead remains in use. No patient c omplications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50323722 ↗MalfunctionAug 19, 2026Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50320850 ↗MalfunctionAug 18, 2026Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50294296 ↗MalfunctionAug 13, 2026Over-Sensing
It was reported that the Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing noted on stored episodes 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 50237230 ↗InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem
It was reported the patient's Implantable Cardioverter Defibrillator (ICD) system was explanted due to an infection. No further patient complications have been reported as a result of this event.
Patient problems: Unspecified Infection
MAUDE report 50234068 ↗MalfunctionJul 30, 2026Over-Sensing
It was reported that the Right Atrial (RA) lead exhibited oversensing on stored Atrial Tachycardia/Atrial Fibrillation (AT/AF) episodes triggering episode misclassification. 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 50086536 ↗MalfunctionJul 13, 2026Signal Artifact/Noise
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25793700 ↗MalfunctionJul 9, 2026Signal Artifact/Noise; Over-Sensing; Under-Sensing; High Capture Threshold
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS. NOISE, OVERSENSING AND UNDERSENSING. THE LEAD WILL BE MONITORED AND 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 25763441 ↗MalfunctionJul 9, 2026Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25762155 ↗InjuryJul 8, 2026High Capture Threshold
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS. THE RA LEAD WAS CAPPED AND WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25744642 ↗MalfunctionJul 7, 2026Under-Sensing
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) RESULTING IN TERMINATION OF DETECTED AT/AF EVENTS 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 25732818 ↗MalfunctionJul 6, 2026Under-Sensing
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING ON THE ATRIAL LEAD DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS AND UNNECESSARY PACING. 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 25723199 ↗MalfunctionJul 6, 2026Over-Sensing; Low impedance
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED LOW IMPEDANCE AND 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 25718934 ↗
Other Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes devices
- Tendril™ STSSt. Jude Medical, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes438 deaths19,632 reports
- Tendril™ STSSt. Jude Medical, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes200 deaths12,708 reports
- INGEVITY™ MRI 7741Boston Scientific Corporation · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes36 deaths7,874 reports
- INGEVITY™+ 7841Boston Scientific Corporation · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes15 deaths7,419 reports
- Tendril™ STSSt. Jude Medical, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes190 deaths6,776 reports
- INGEVITY™+ 7842Boston Scientific Corporation · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes21 deaths5,995 reports
- SelectSecure™ MRI SureScan™ 383069Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes50 deaths5,027 reports
- CapSureFix Novus MRI™ SureScan® 5076-45Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes40 deaths5,000 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.