Capsure® EPI 4965-35 (UDI 00681490116503)Recalls & reported problems

Summary

The FDA's MAUDE database contains 207 adverse event reports that list this exact device (DI 00681490116503), received between Feb 10, 2015 and Sep 18, 2026 — classified as 123 injuries, 84 malfunctions.

The most frequently reported specific device problem is “Fracture” (49 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 207 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Capturing Problem; Impedance Problem

  It was reported that the Right Atrial (RA) lead exhibited significant increase in bipolar impedance and capture thresholds along with decrease in P waves. 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 50815844 ↗
• InjuryAug 31, 2026Low impedance; Unstable Impedance

  It was reported that the epicardial Right Ventricular (RV) lead exhibited chronically low impedance measurements, and variable impedance. Programming changes were performed. 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 50516850 ↗
• MalfunctionAug 27, 2026Low impedance

  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 50473599 ↗
• MalfunctionAug 27, 2026High impedance

  It was reported that the Right Atrial (RA) lead exhibited loss of capture and the Right Ventricular (RV) lead exhibited high impedance. Low P waves were also noted The RA and RV 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 50472267 ↗
• InjuryAug 27, 2026Failure to Capture; Under-Sensing

  It was reported that the Right Atrial (RA) and Right Ventricular (RV) leads exhibited no capture and no sensing. The leads were capped without replacement. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50470894 ↗
• InjuryAug 10, 2026High impedance

  It was reported that the Right Atrial (RA) lead exhibited high impedance. 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 50191756 ↗
• MalfunctionJun 4, 2026Low impedance

  IT WAS REPORTED THAT THE DEVICE EXPERIENCED A PARTIAL ELECTRICAL RESET WHERE DIAGNOSTIC DATA SUCH AS PACING PERCENTAGES AND RATE HISTOGRAMS WERE CLEARED, HOWEVER PARAMETER VALUES REMAINED UNCHANGED. IT WAS ALSO NOTED THAT THE RIGHT ATRIAL (RA) LEAD HAD LOW IMPEDANCE. THE DEVICE AND 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 25393280 ↗
• MalfunctionMay 20, 2026Over-Sensing

  IT WAS REPORTED THAT THE EPICARDIAL RIGHT VENTRICULAR (RV) LEAD EXHIBITED SHORT V-V INTERVALS. THE LEAD REMAINS IN USE. IT WAS ALSO NOTED THAT THE PREVIOUS RV LEAD WAS CAPPED DUE TO NO CAPTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25228505 ↗
• MalfunctionFeb 13, 2026Fracture

  THE RIGHT ATRIAL (RA) LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24331173 ↗
• MalfunctionFeb 10, 2026High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED OUT OF RANGE (OOR) HIGH PACING IMPEDANCE AND A POLARITY SWITCH. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. 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 24307716 ↗
• 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 24277499 ↗
• MalfunctionSep 15, 2025Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD TRIGGERED AN ALERT FOR OUT OF RANGE (OOR) LOW IMPEDANCE. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING, INTERMITTENT FAR FIELD R-WAVE OVERSENSING AND UNDERSENSING ON STORED ELECTROGRAMS (EGM). 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 23049529 ↗
• MalfunctionSep 9, 2025High Capture Threshold; Unstable Capture Threshold; High Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED VARIABLE THRESHOLD AND HIGH THRESHOLD. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT OF RANGE LOW IMPEDANCE. BOTH 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 23002674 ↗
• MalfunctionAug 11, 2025High impedance; Low impedance; High impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED AN UNDEFINED HIGH BIPOLAR IMPEDANCE WARNING AND A LOW UNIPOLAR IMPEDANCE WARNING. 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 22768861 ↗
• MalfunctionJul 18, 2025Low impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW IMPEDANCE. IT WAS ALSO REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A FALSE RV LOW IMPEDANCE MEASUREMENT. THE IPG WAS ALSO NOTES TO FALSE HIGH IMPEDANCE ALERTS AND FALSE POLARITY SWITCHES DUE TO LEAD MONITOR IS ADAPTIVE WHILE THE LEADS WERE PROGRAMMED UNIPOLAR. THE RV LEAD AND IPG 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 22539896 ↗
• InjuryJul 10, 2025Over-Sensing; Low impedance; Over-Sensing; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A HIGH NUMBER OF SHORT V-V INTERVALS, OVERSENSING AND TRIGGERED AN ALERT FOR OUT OF RANGE (OOR) LOW IMPEDANCE. IN ADDITION, THE RIGHT ATRIAL (RA) LEAD WAS OVERSENSING AND TRIGGERED AN ALERT FOR OUT OF RANGE (OOR) LOW 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 22466320 ↗
• MalfunctionJun 5, 2025Low impedance; Low impedance

  IT WAS REPORTED THAT THE EPICARDIAL RIGHT VENTRICULAR (RV) LEAD EXHIBITED CHRONIC LOW IMPEDANCE WARNINGS. THE IMPLANTABLE PULSE GENE RATOR (IPG) ALSO EXHIBITED POSSIBLE FALSE LOW IMPEDANCE. THE LEAD AND IPG 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 22149023 ↗
• InjuryJun 4, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) EPICARDIAL PACING LEADS EXHIBITED NO CAPTURE. THE LEADS WERE INACTIVATED AND REMAIN IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22144065 ↗
• MalfunctionJun 4, 2025Low impedance; Low impedance

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD TRIGGERED A WARNING FOR A LOW PACING IMPEDANCE MEASUREMENT. IT WAS ALSO REPORTED THAT THE PATIENT WAS EXPERIENCING SHORTNESS OF BREATH. THE LV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea

  MAUDE report 22143407 ↗
• MalfunctionMay 30, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED BY THE CLINICIAN THAT THERE WAS A LARGE CURRENT DRAIN ON THE DEVICE AND THAT THE LONGEVITY WAS ESTIMATED AT THREE YEARS ON A RECENTLY IMPLANTED DEVICE. IT WAS FURTHER REPORTED THERE WAS FAR FIELD R WAVE OVERSENSING. ADDITIONAL INFORMATION OBTAINED INDICATED THE LONGEVITY ESTIMATED WAS DUE TO A NEED TO "RECALIBRATE" THE DEVICE AND THE ESTIMATE PROVIDED BY TECHNICAL SERVICES WAS WHAT WAS EXPECTED, APPROXIMATELY NINE YEARS. MULTIPLE ATTEMPTS TO PROGRAM AROUND THE OVERSENSING WERE UNSUCCESSFUL. IT WAS REPORTED APPROXIMATELY THIRTEEN YEARS LATER THAT THE FAR FIELD R-WAVE (FFRW) OVERSENSING CONTINUED RESULTING IN INAPPROPRIATE MODE SWITCHING AND ACCOUNTING OF ATRIAL FIBRILLATION (AF) BURDEN. DOUBLE COUNTING OF R-WAVES WAS ALSO NOTED AND ASSOCIATED WITH LATENT LEFT VENTRICULAR PACES BEING SENSED ON THE RIGHT VENTRICULAR CHANNEL. THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS AND THE DEVICE 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 22113962 ↗
• MalfunctionMay 13, 2025Failure to Capture; High impedance; High Capture Threshold; Failure to Capture; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW IMPEDANCE AND THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS ,NO CAPTURE AND HIGH IMPEDANCE. THE RV AND RA 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 22009521 ↗
• MalfunctionMay 13, 2025Low impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW IMPEDANCE AND THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS, NO CAPTURE AND HIGH IMPEDANCE. THE RV AND RA 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 22009519 ↗
• MalfunctionMay 5, 2025High impedance; High impedance

  IT WAS REPORTED THAT A LEFT VENTRICULAR (LV) LEAD ALERT TRIGGERED DUE TO HIGH UNDEFINED PACING IMPEDANCE. THE LV 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 21962986 ↗
• InjuryApr 2, 2025Fracture; High impedance; Capturing Problem; Fracture; High impedance; Capturing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS FRACTURED AND EXHIBITED RISING THRESHOLDS AND HIGH OUT OF RANGE LEAD IMPEDANCE. THE LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21750589 ↗
• MalfunctionFeb 24, 2025Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDER SENSING. IT WAS ALSO REPORTED THAT THE RV LEAD EXHIBITED SHORT V-V INTERVALS. 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 21446606 ↗