Capsure® EPI 4968-35 (UDI 00681490116725)Recalls & reported problems

Summary

The FDA's MAUDE database contains 438 adverse event reports that list this exact device (DI 00681490116725), received between Nov 20, 2015 and Sep 8, 2026 — classified as 6 deaths, 265 injuries, 167 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (132 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 438 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026Appropriate Device Problem Term/Code Not Available

  It was reported by the patient's representative that the patient is "reacting badly" to the Implantable Pulse Generator (IPG) system with plans for a system revision. The IPG system remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Insufficient Information

  MAUDE report 50671247 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported by the patient's representative that the patient is "reacting badly" to the Implantable Pulse Generator (IPG) system with plans for a system revision. The IPG system remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Insufficient Information

  MAUDE report 50671237 ↗
• MalfunctionAug 27, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that post generator change the lead exhibited a "wiring issue." The Right Ventricular (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 50473619 ↗
• MalfunctionAug 27, 2026High Capture Threshold

  It was reported that the Right Atrial (RA) lead exhibited low impedance. It was also reported that the Right Ventricular (RV) lead exhibited high thresholds. Both 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 50473604 ↗
• InjuryAug 13, 2026Fracture; Labelling, Instructions for Use or Training Problem

  It was reported that the Right Ventricular (RV) lead was inactivated and replaced due to a fracture. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50235550 ↗
• InjuryAug 10, 2026Fracture; Impedance Problem

  It was reported that the Right Ventricular (RV) lead was fractured and exhibited an Out of Range (OOR) impedance spike. The RV 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 50189907 ↗
• InjuryJul 7, 2026Break

  IT WAS REPORTED THAT DURING AN OPEN-HEART SURGERY PROCEDURE, THE PHYSICIAN ACCIDENTALLY DAMAGING BOTH THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS. BOTH LEADS PARTIALLY REMAINS IN PATIENT AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25729114 ↗
• MalfunctionJul 3, 2026High Capture Threshold

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A PARTIAL ELECTRICAL RESET. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) EPICARDIAL LEAD EXHIBITED OVER-SENSING AND THAT THE RIGHT VENTRICULAR (RV) EPICARDIAL LEAD EXHIBITED HIGH THRESHOLDS. THE IPG SYSTEM 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 25701734 ↗
• InjuryJun 10, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE LEAD WAS REPROGRAMMED 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 25464512 ↗
• MalfunctionJun 5, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN. THE RIGHT ATRIAL (RA) LEAD HAS A FRACTURE BUT IS OKAY IN UNIPOLAR. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain

  MAUDE report 25407935 ↗
• InjuryJun 5, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION APPROXIMATELY ONE MONTH POST GENERATOR CHANGE IT WAS ALSO NOTED THEY PATIENT HAD A POCKET HEMATOMA. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hematoma; Unspecified Infection

  MAUDE report 25406817 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION APPROXIMATELY ONE MONTH POST GENERATOR CHANGE IT WAS ALSO NOTED THEY PATIENT HAD A POCKET HEMATOMA. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hematoma; Unspecified Infection

  MAUDE report 25406797 ↗
• MalfunctionMay 29, 2026Over-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS AND RESULTING IN UNNECESSARY PACING AT TIMES. 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 25329948 ↗
• MalfunctionMay 15, 2026Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE EPICARDIAL RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR HIGH RATE-NON-SUSTAINED E PISODES AND SENSING INTEGRITY COUNTER (SIC) IN ADDITION TO HIGH THRESHOLD AND T-WAVE OVERSENSING (TWOS) RESULTING IN INHIBITION OF PACING; POST DEVICE DEFIBRILLATION. IT WAS FURTHER REPORTED THAT THE EPICARDIAL RV DEFIBRILLATOR LEAD EXHIBITED OUT OF RANGE (OOR) HIGH IMPEDANCE. 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 25194135 ↗
• InjuryApr 14, 2026Failure to Capture; Fracture; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS FRACTURED. IT WAS NOTED THERE WAS OVERSENSING AND NO CAPTURE ON THE LEAD. THE LEAD WAS INACTIVATED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24870116 ↗
• MalfunctionApr 13, 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 24860915 ↗
• InjuryApr 9, 2026Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE EPICARDIAL RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING AND NOISE ON STORED EPISODE RESULTING IN INHIBITION OF PACING AND MISCLASSIFICATION OF EPISODE TYPE. LEAD FRACTURE WAS SUSPECTED. THE RA LEAD REMAINS IN USE. IT WAS ALSO REPORTED THAT THE EPICARDIAL RIGHT VENTRICULAR (RV) LEAD EXHIBITED POSSIBLE OVERSENSING AND RISING IMPEDANCE. LEAD FRACTURE WAS SUSPECTED. 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 24830352 ↗
• InjuryMar 12, 2026Appropriate Device Problem Term/Code Not Available; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS CAPPED AND REPLACED FOR AN UNKNOWN REASON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24579173 ↗
• InjuryFeb 25, 2026Signal Artifact/Noise; High impedance; Over-Sensing; Under-Sensing; Decreased Sensitivity

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHORTNESS OF BREATH. A LEAD ALERT TRIGGERED ON THE RIGHT ATRIAL (RA) LEAD DUE TO UNDEFINED HIGH PACING IMPEDANCE, FAR FIELD R-WAVE (FFRW) OVERSENSING, AND NOISE. IN ADDITION, THERE WAS ATRIAL UNDERSENSING WITH DECREASED AMPLITUDES. REPROGRAMMING WAS PERFORMED TO CHANGE THE DEVICE TO SINGLE CHAMBER FIXED RATE. THE RA LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea

  MAUDE report 24444870 ↗
• MalfunctionFeb 19, 2026Signal Artifact/Noise; High impedance; Over-Sensing

  IT WAS REPORTED THAT A PARTIAL ELECTRICAL RESET OCCURRED. IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH NUMBER OF SHORT V-V INTERVALS, NOISE AND LOW IMPEDANCES. FAR FIELD R-WAVE (FFRW) OVERSENSING, NOISE AND HIGH IMPEDANCES WAS NOTED ON THE RIGHT ATRIAL (RA) LEAD. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM 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 24386457 ↗
• MalfunctionFeb 10, 2026High impedance

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS PLUGGED INTO THE RIGHT ATRIAL (RA) LEAD PORT AND THE RA LEAD WAS PLUGGED INTO THE LV PORT ON THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P). IT WAS ALSO REPORTED THAT THE RA LEAD EXHIBITED A SUSPECTED FRACTURE AND FAR FIELD R-WAVE (FFRW) OVERSENSING AND FAILED AN ATRIAL LEAD POSITION CHECK. IT WAS ALSO REPORTED THAT THE RA LEAD TRIGGERED AN ALERT FOR OUT OF RANGE (OOR) HIGH IMPEDANCE.  THE PATIENT THEN UNDERWENT A STERNOTOMY PROCEDURE TO REVISE THE RA LEAD. IT WAS THEN REPORTED AFTER THE PROCEDURE, THAT THE RV LEAD HAD TRIGGERED AN ALERT FOR OOR HIGH IMPEDANCE. IT WAS FURTHER REPORTED THAT LEAD WAS NOT FULLY SEATED IN THE CRT-P HEADER. THE CRT-P AND 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 24302748 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE SOURCE OF INFECTION IS UNKNOWN. IT WAS FURTHER NOTED THAT NO INFLAMMATORY INFILTRATE OR OTHER DIAGNOSTIC ABNORMALITY WERE OBSERVED. NO ORGANISMS WERE IDENTIFIED.

  Patient problems: Medical device site infection

  MAUDE report 24277172 ↗
• InjuryJan 30, 2026Fracture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A FRACTURE AND HIGH IMPEDANCE. THE RV 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 24219702 ↗
• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A BLOODSTREAM INFECTION AND EXPERIENCED SWELLING. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 24092652 ↗
• InjuryDec 17, 2025Break; Break

  IT WAS REPORTED THAT THERE WAS A "MECHANICAL BREAKDOWN OF CARDIAC ELE". THE LEFT VENTRICULAR (LV) LEAD, RIGHT ATRIAL (RA) LEAD AND THE RIGHT VENTRICULAR (RV) LEAD WERE REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23825560 ↗