Capsure® EPI 4965-15 (UDI 00613994501721)Recalls & reported problems

Summary

The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 00613994501721), received between Mar 16, 2017 and Jul 30, 2026 — classified as 1 death, 91 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Fracture” (50 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 129 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Fracture

  It was noted that the RA lead did not exhibit a fracture.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50083254 ↗
• MalfunctionJan 21, 2026Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A FALSE HIGH THRESHOLD MEASUREMENT AND RVCM NOT RUNNING. IT WAS FURTHER NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OCCASIONAL FAR FIELD R-WAVE (FFRW) OVERSENSING. THE IPG 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 24131907 ↗
• MalfunctionNov 11, 2025Low impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED LOW IMPEDANCE. 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 23520432 ↗
• InjuryNov 10, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  THE 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 23510579 ↗
• InjuryAug 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A LEAD FRACTURE. 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 22858387 ↗
• MalfunctionAug 13, 2025Low impedance; Impedance Problem; Low impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT OF RANGE UNIPOLAR 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 22791686 ↗
• MalfunctionAug 13, 2025Low impedance; Impedance Problem; Low impedance; Impedance Problem

  IT WAS FURTHER REPORTED THAT THE RA AND THE RV LEAD IMPEDANCES WERE LOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22791673 ↗
• InjuryAug 5, 2025Failure to Capture; Fracture; High impedance; Pacing Problem; Under-Sensing; High Capture Threshold; Failure to Capture; Fracture; High impedance; Pacing Problem; Under-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED SUSPECTED FRACTURE, HIGH UNDEFINED IMPEDANCE, HIGH THRESHOLD, NO CAPTURE AT HIGH OUTPUT, INAPPROPRIATE PACING AND NOT SENSING. 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 22714345 ↗
• InjuryJul 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS NOTED TO BE FRACTURED. THE 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 22662654 ↗
• InjuryJul 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A LOW VOLTAGE FRACTURE. IT WAS NOTED THE RV LEAD EXHIBITED A UNIPOLAR LEAD IMPEDANCE WARNING ALSO. THE RV LEAD WAS PARTIALLY EXTRACTED, 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 22565061 ↗
• InjuryJul 15, 2025Failure to Capture; Fracture; High impedance; Failure to Capture; Fracture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDEFINED HIGH IMPEDANCE, NO CAPTURE AND THE LEAD WAS NOTED TO BE FRACTURED. THE 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 22507468 ↗
• MalfunctionJul 10, 2025Low impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT OF RANGE LOW 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 22466743 ↗
• InjuryJun 12, 2025Fracture; High impedance; Capturing Problem; Fracture; High impedance; Capturing Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED A CAPTURE ISSUE, UNDEFINED HIGH IMPEDANCE AND A LOW VOLTAGE LEAD FRACTURE. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A CAPTURE ISSUE, OVERSENSING, UNDEFINED HIGH IMPEDANCE AND A LOW VOLTAGE LEAD FRACTURE. THE 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 22192512 ↗
• InjuryJun 12, 2025Fracture; High impedance; Over-Sensing; Capturing Problem; Fracture; High impedance; Over-Sensing; Capturing Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED A CAPTURE ISSUE, UNDEFINED HIGH IMPEDANCE AND A LOW VOLTAGE LEAD FRACTURE. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A CAPTURE ISSUE, OVERSENSING, UNDEFINED HIGH IMPEDANCE AND A LOW VOLTAGE LEAD FRACTURE. THE 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 22192510 ↗
• InjuryJun 4, 2025Failure to Capture; Fracture; High impedance; High Capture Threshold; Failure to Capture; Fracture; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS FRACTURED AND EXHIBITED SPIKED AND HIGH IMPEDANCE AND NO CAPTURE. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS FRACTURED AN EXHIBITED HIGH IMPEDANCE, HIGH THRESHOLDS AND NO CAPTURE. IT WAS FURTHER REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE BATTERY DEPLETION. THE IPG SYSTEM 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 22141158 ↗
• InjuryJun 4, 2025Failure to Capture; Fracture; High impedance; Impedance Problem; Failure to Capture; Fracture; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS FRACTURED AND EXHIBITED SPIKED AND HIGH IMPEDANCE AND NO CAPTURE. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS FRACTURED AN EXHIBITED HIGH IMPEDANCE, HIGH THRESHOLDS AND NO CAPTURE. IT WAS FURTHER REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE BATTERY DEPLETION. THE IPG SYSTEM 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 22141126 ↗
• InjuryMay 30, 2025Intermittent Capture; High impedance; Over-Sensing; Intermittent Capture; High impedance; Over-Sensing

  IT WAS FURTHER REPORTED THAT THE IPG WAS EXPLANTED.

  Patient problems: Heart Block; Unspecified Infection; Wound Dehiscence

  MAUDE report 22113423 ↗
• InjuryMay 28, 2025Intermittent Capture; Failure to Capture; Device Dislodged or Dislocated; High Capture Threshold; Intermittent Capture; Failure to Capture; Device Dislodged or Dislocated; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE. IT WAS ALSO REPORTED THAT THE RV LEAD EXHIBITED INTERMITTENT RV CAPTURE, LOSS OF RV CAPTURE AND ELEVATED CAPTURE THRESHOLDS. THE RV LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Asystole; Syncope/Fainting

  MAUDE report 22096463 ↗
• InjuryMay 22, 2025Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN INSULATION BREACH. THE RV LEAD WAS PARTIALLY 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 22068365 ↗
• MalfunctionApr 3, 2025Break; Break

  THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) 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 21762785 ↗
• MalfunctionApr 3, 2025Break; Break

  THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) 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 21762758 ↗
• InjuryMar 31, 2025Intermittent Capture; Failure to Capture; Under-Sensing; Low impedance; Intermittent Capture; Failure to Capture; Under-Sensing; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDEFINED LOW IMPEDANCE, UNDERSENSING, INTERMITTENT AND LOSS OF CAPTURE. 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 21730933 ↗
• InjuryMar 25, 2025Failure to Capture; Low impedance; Failure to Capture; Low impedance

  IT WAS REPORTED POST IMPLANT THAT THERE WAS A RIGHT VENTRICULAR (RV) LEAD IMPEDANCE ISSUE WITH A READING OF 3401. IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED A LOW IMPEDANCE WARING. IT WAS ALSO REPORTED THAT THERE WAS A POCKET REVISION ON THE DAY OF IMPLANT DUE TO LOSS OF CAPTURE. THE RV LEAD AND THE 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 21687480 ↗
• InjuryMar 25, 2025Failure to Capture; High impedance; Failure to Capture; High impedance

  IT WAS REPORTED POST IMPLANT THAT THERE WAS A RIGHT VENTRICULAR (RV) LEAD IMPEDANCE ISSUE WITH A READING OF 3401. IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED A LOW IMPEDANCE WARING. IT WAS ALSO REPORTED THAT THERE WAS A POCKET REVISION ON THE DAY OF IMPLANT DUE TO LOSS OF CAPTURE. THE RV LEAD AND THE 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 21687469 ↗
• MalfunctionFeb 26, 2025Low impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A POSSIBLE CAPTURE ISSUE. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED LOW IMPEDANCE. BOTH 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 21468707 ↗