Capsure® EPI 4968-25Recalls & reported problems
Medtronic, Inc. · LEAD 4968-25 US BIPOLAR EPICARDIAL 25CM · Class 3 · Implant
All models of Capsure EPI (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Medtronic Capsure EPI lead is a wire that carries signals between a pacemaker and the heart. Its 835 reports include 13 deaths and 600 injuries. Many describe the lead not reliably pacing or sensing the heartbeat, and some describe the lead breaking, often followed by replacement. 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
- 843
- Deaths reported
- 13
- Injuries reported
- 604
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 843 adverse event reports that list this exact device (DI 00613994492272), received between Dec 27, 2016 and Sep 29, 2026 — classified as 13 deaths, 604 injuries, 226 malfunctions.
The most frequently reported specific device problem is “High Capture Threshold” (224 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- High Capture Threshold224
- Fracture211
- High impedance186
- Over-Sensing173
- Failure to Capture128
- Adverse Event Without Identified Device or Use Problem82
- Signal Artifact/Noise76
- Impedance Problem72
Patient problems
- No Clinical Signs, Symptoms or Conditions506
- No Known Impact Or Consequence To Patient107
- Unspecified Infection54
- Bradycardia35
- No Consequences Or Impact To Patient35
- Syncope/Fainting20
- Dizziness16
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available12
Recent adverse event reports
The 25 most recent of 843 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Under-Sensing
It was reported that the Right Atrial (RA) lead and the Right Ventricular (RV) lead exhibited undersensing. The leads 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 50933336 ↗MalfunctionSep 29, 2026Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933308 ↗InjurySep 25, 2026Break; Fracture; Mechanical Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem
It was reported that during attempted removal of a lead pin from a pediatric Implantable Pulse Generator (IPG) header the lead remained trapped in the port. The setscrew and grommet were completely removed and lead was stuck. Lead was then held static and the generator was attempted to be "twisted" off the lead. The lead insulation breached and pulled away, exposing the conductors. The pin was removed from device port. The Lead was capped and replaced. The pediatric IPG was also removed and replaced. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895443 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced an infection. It was further noted that the patient experienced erosion. The leadless I mplantable Pulse Generator (IPG) and epicardial lead was explanted. No further patient complications have been reported as a result of this event.
Patient problems: Erosion; Medical device site infection; Unspecified Infection
MAUDE report 50752172 ↗MalfunctionSep 10, 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 50714314 ↗InjurySep 9, 2026Failure to Capture; Over-Sensing
It was reported that the patient experienced syncope. It was also reported that the Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing and possible loss of capture. The RA lead remains in use. No further patient complications have been reported as a result of this event.
Patient problems: Syncope/Fainting
MAUDE report 50688196 ↗InjurySep 8, 2026Signal Artifact/Noise; Over-Sensing; High Capture Threshold
It was reported that the Right Ventricular (RV) lead exhibited high thresholds, oversensing and noise, 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 50666765 ↗MalfunctionSep 7, 2026Break; Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50646881 ↗InjurySep 4, 2026High impedance
It was reported that the Right Atrial (RA) lead and the Right Ventricular (RV) lead exhibited high impedance. Both leads were explanted and replaced. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50606866 ↗InjurySep 4, 2026High impedance
It was reported that the Right Atrial (RA) lead and the Right Ventricular (RV) lead exhibited high impedance. Both leads were explan ted and replaced. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50606797 ↗MalfunctionSep 2, 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 50564758 ↗InjurySep 2, 2026Fracture
It was reported that both the Right Atrial (RA) lead and Right Ventricular (RV) lead were fractured. Both leads were capped and repl aced. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50561665 ↗InjurySep 2, 2026Fracture
It was reported that both the Right Atrial (RA) lead and Right Ventricular (RV) lead were fractured. Both leads were capped and repl aced. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50561614 ↗InjurySep 1, 2026Capturing Problem; High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50540677 ↗InjuryAug 31, 2026Failure to Capture
It was reported that the Right Ventricular (RV) epicardial lead exhibited loss of capture which couldn¿t seem to duplicate consistently. The RV epicardial lead was explanted and replaced. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50519095 ↗MalfunctionAug 27, 2026Under-Sensing
It was reported that the Right Atrial (RA) lead exhibited undersensing causing premature episode termination. 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 50471088 ↗InjuryAug 27, 2026Fracture
It was reported that the Right Atrial (RA) lead exhibited a low voltage fracture. The RA lead was explanted and replaced. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50471045 ↗MalfunctionAug 21, 2026Signal Artifact/Noise
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50368638 ↗InjuryAug 20, 2026Failure to Capture; Fracture; High impedance; Under-Sensing
It was reported that the patient experienced dizziness. It was further reported that the Right Ventricular (RV) lead exhibited no capture, no sensing, high impedance and was fractured. The lead was capped and replaced. No patient complications have been reported as a result of this event.
Patient problems: Dizziness
MAUDE report 50344773 ↗MalfunctionAug 17, 2026Fracture; High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50286748 ↗MalfunctionAug 17, 2026High impedance; High Capture Threshold
It was further reported that the Leadless IPG was reprogrammed off.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50272863 ↗MalfunctionAug 13, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50236405 ↗MalfunctionAug 13, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50236370 ↗InjuryAug 11, 2026Fracture; Impedance Problem
It was reported that the Left Ventricular (LV) lead exhibited a fracture and rising 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 50207089 ↗MalfunctionAug 7, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50176059 ↗
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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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