CapSure Sense MRI™ SureScan™ 407452 (UDI 00643169448858)Recalls & reported problems

Summary

The FDA's MAUDE database contains 699 adverse event reports that list this exact device (DI 00643169448858), received between Jun 8, 2017 and Sep 30, 2026 — classified as 8 deaths, 440 injuries, 251 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (192 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 699 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited high thresholds. The lead was explanted and replaced. No patient comp lications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947427 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed a pocket infection. The Implantable Pulse Generator (IPG) system was explanted and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50945978 ↗
• InjurySep 30, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that post Implantable Pulse Generator (IPG) system implant the patient was not feeling well and was having hypotension that increasingly worsened and they developed shock lock symptoms. A pericardial effusion was discovered and patient was treated for pericardial tamponade. The patient was in Intensive Care Unit (ICU) and intubated. The Right Atrial (RA) lead was noted to have decreased since implant. The IPG system remains in use.  No further patient complications have been reported as a result of this event.

  Patient problems: Cardiac Tamponade; Cardiogenic Shock; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 50944868 ↗
• InjurySep 30, 2026Failure to Capture; Electrical /Electronic Property Problem; High impedance; Impedance Problem; High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited no capture, high thresholds, a polarity switch and, spikes in impedance,  high undefined impedances. The RV 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 50944786 ↗
• MalfunctionSep 29, 2026Signal Artifact/Noise; Electrical /Electronic Property Problem; High impedance; Over-Sensing; Impedance Problem; High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited oversensing, noise, high impedance, rising impedance, polarity switch and high thresholds. 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 50930548 ↗
• MalfunctionSep 28, 2026Under-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited under sensing. 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 50913632 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported by the patient that they experienced an infection. The Implantable Pulse Generator (IPG) system was removed and replaced with a Leadless IPG. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50911594 ↗
• InjurySep 23, 2026Capturing Problem; High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited rising and high thresholds. 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 50868967 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced a pocket infection and erosion. A skin ulcer was noted at the pocket site. The Implantable Pulse Generator (IPG) system was removed. No further patient complications have been reported as a result of this event.

  Patient problems: Medical device site infection; Pocket Erosion; Ulcer

  MAUDE report 50866863 ↗
• MalfunctionSep 18, 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 50816282 ↗
• MalfunctionSep 15, 2026Pacing Problem; Under-Sensing; Decreased Sensitivity

  It was reported that the patient experienced altered mental status. It was also reported that Right Ventricular (RV) lead exhibited under sensing during ventricular arrhythmias resulting in inappropriate pacing. Additionally, RV lead displayed abrupt drop in R-wave amplitude. The RV lead remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Confusion/ Disorientation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50770203 ↗
• MalfunctionSep 14, 2026Under-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited undersensing resulting in misclassification of arrhythmia episode type. 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 50751928 ↗
• InjurySep 14, 2026Failure to Capture

  Patient problems: Bradycardia; Syncope/Fainting

  MAUDE report 50751125 ↗
• InjurySep 11, 2026Signal Artifact/Noise; Over-Sensing; Capturing Problem; Device Dislodged or Dislocated; High Capture Threshold

  It was reported that post implant the Right Ventricular (RV) lead dislodged and exhibited noise on stored episodes and high and rising thresholds. Oversensing and short v-v intervals were also noted. The lead was reprogrammed off with the device set to AAI. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50732455 ↗
• MalfunctionSep 11, 2026Capturing Problem

  It was reported that the Right Atrial (RA) lead exhibited loss of capture and undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) events resulting in uneccessary pacing at times. The Right Ventricular (RV) lead exhibited rising 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 50731115 ↗
• InjurySep 10, 2026Fracture; High impedance; Impedance Problem; High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited rising impedance, high impedance, high thresholds. The RV lead was su spected to be fractured. The RV lead was reprogrammed and later explanted. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 50710958 ↗
• MalfunctionSep 9, 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 50688373 ↗
• MalfunctionSep 3, 2026Pacing Problem; Under-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited undersensing resulting in inappropriate 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 50585087 ↗
• InjurySep 2, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the patient's transvenous Implantable Pulse Generator (IPG) system was explanted as it was causing them discomfort. A leadless IPG was implanted instead. No further patient complications have been reported as a result of this event.

  Patient problems: Discomfort

  MAUDE report 50562136 ↗
• MalfunctionSep 1, 2026Capturing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50543438 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Cardiac Perforation

  MAUDE report 50540510 ↗
• MalfunctionAug 21, 2026Pacing Problem; Under-Sensing

  It was reported that  the Right Ventricular (RV) lead  exhibited undersensing resulting in inappropriate pacing. 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 50370533 ↗
• InjuryAug 21, 2026Device Dislodged or Dislocated; High Capture Threshold

  It was reported that approximately two months post implant the Right Ventricular (RV) lead had dislodged. It was further reported that the RV lead exhibited high thresholds. The RV 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 50365995 ↗
• MalfunctionAug 18, 2026Failure to Capture; Pacing Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50296157 ↗
• InjuryAug 13, 2026Capturing Problem; Impedance Problem; High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited rising impedance, rising thresholds, and high thresholds. The lead was reprogrammed and later 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 50234712 ↗