CapSureFix Novus MRI™ SureScan® 5076-65 (UDI 00643169633773)Recalls & reported problems

Summary

The FDA's MAUDE database contains 148 adverse event reports that list this exact device (DI 00643169633773), received between Apr 10, 2018 and Sep 30, 2026 — classified as 3 deaths, 86 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (30 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 148 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Pacing Problem; Under-Sensing

  It was reported that there was undersensing exhibited on the atrial lead during Atrial Tachycardia/Atrial Fibrillation (AT/AF) stored episodes resulting in termination of AT/AF detected event(s) in progress and unnecessary pacing. 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 50942999 ↗
• MalfunctionSep 8, 2026Failure to Capture; Pacing Problem

  It was reported that post implant the patient experienced rates in fifties beats per minute. The Right Ventricular (RV) lead capture could not be confirmed. No pacing was also noted. The RV lead remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Bradycardia

  MAUDE report 50669725 ↗
• InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 50364486 ↗
• InjuryAug 13, 2026Over-Sensing

  It was reported that the Right Atrial (RA) lead exhibited oversensing. It was also reported that the Right Ventricular (RV) lead exhibited oversensing. The leads were 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 50233444 ↗
• InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Right Atrial (RA) lead exhibited placement difficulty due to patient anatomy. 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 50233354 ↗
• InjuryJul 29, 2026Over-Sensing; Pacing Problem

  It was reported that the patient experienced bradycardia. It was reported that the Right Ventricular (RV) Left Bundle Branch (LBB) lead exhibited T-Wave Oversensing (TWOS) resulting in inhibition of pacing. The RV LBB lead was reprogrammed and remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Bradycardia

  MAUDE report 50068271 ↗
• InjuryJun 17, 2026Device Dislodged or Dislocated

  IT WAS REPORTED EIGHT DAYS POST IMPLANT THAT THE PATIENT EXPERIENCED BRADYCARDIA, DIZZINESS, AND COMPLETE HEART BLOCK WITH ESCAPE RATE OF APPROXIMATELY THIRTY BEATS PER MINUTE. IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED. THE RV LEAD WAS REPOSITIONED AND THEN REPLACED. THREE DAYS LATER, THE NEW RV LEAD DISLODGED. THE NEW RV LEAD WAS REPOSITIONED AND THEN THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS IPG. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Dizziness; Heart Block

  MAUDE report 25530563 ↗
• InjuryJun 12, 2026Fracture; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE. IT WAS SUSPECTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS FRACTURED. IT WAS ALSO REPORTED THAT THE RV LEAD EXHIBITED SHORT V-V INTERVALS AND WAS REPROGRAMMED. THE RV LEAD WAS CAPPED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 25484811 ↗
• MalfunctionJun 11, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING ON STORED ELECTROGRAMS (EGM) RESULTING IN OVER-PACING. THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25467473 ↗
• MalfunctionJun 10, 2026Electrical /Electronic Property Problem; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED SEVERAL LOW PACING IMPEDANCE MEASUREMENTS AND A POLARITY SWITCH HAD OCCURRED. 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 25455508 ↗
• MalfunctionMay 12, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED SINGULAR VENTRICULAR UNDER SENSED EVENT RESULTING IN OVER 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 25146355 ↗
• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED APPROXIMATELY SEVEN WEEKS POST IMPLANT THAT THE PATIENT EXPERIENCED A POCKET INFECTION, PURULENT DISCHARGE, REDNESS AND WOUND DEHISCENCE. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTEDAS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Medical device site infection; Purulent Discharge; Wound Dehiscence

  MAUDE report 25091909 ↗
• MalfunctionApr 20, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) STORED 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 24932213 ↗
• DeathMar 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST IMPLANT OF AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM, THE PATIENT EXPERIENCED PRE-SYNCOPE AND WAS NOT FEELING WELL. THE PATIENT WAS THEN FOUND DECEASED AT THEIR HOME FROM AN UNKNOWN CAUSE.

  Patient problems: Presyncope

  MAUDE report 24659792 ↗
• InjuryMar 12, 2026Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ONE DAY POST IMPLANT THAT THE RIGHT VENTRICULAR (RV) LEAD MALFUNCTIONED. 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 24577958 ↗
• InjuryFeb 19, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, DISCOMFORT AND PARESTHESIA. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPL ANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Pain; Paresthesia

  MAUDE report 24386414 ↗
• InjuryDec 30, 2025Appropriate Device Problem Term/Code Not Available; High Capture Threshold; Appropriate Device Problem Term/Code Not Available; High Capture Threshold

  IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED FEVER, SHAKING AND CHILLS. IT WAS ALSO FURTHER REPORTED THAT VEGETATION WAS NOTED ON THE RV LEAD.

  Patient problems: Chills; Fever; No Clinical Signs, Symptoms or Conditions; Purulent Discharge; Shaking/Tremors; Unspecified Infection

  MAUDE report 23919872 ↗
• MalfunctionDec 2, 2025Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING RESULTING IN UNNECESSARY 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 23697099 ↗
• InjuryNov 11, 2025Signal Artifact/Noise; High impedance; Over-Sensing; Signal Artifact/Noise; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCE, NOISE AND OVERSENSING. THE LEAD WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23521172 ↗
• MalfunctionNov 5, 2025Unstable Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED VARIABLE 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 23477165 ↗
• InjuryOct 29, 2025Signal Artifact/Noise; Electrical /Electronic Property Problem; High impedance; Over-Sensing; Pacing Problem; Impedance Problem; Signal Artifact/Noise; Electrical /Electronic Property Problem; High impedance; Over-Sensing; Pacing Problem; Impedance Problem

  IT WAS FURTHER REPORTED THAT THE RV LEAD EXHIBITED A SPIKE IN IMPEDANCE. THE LEAD WAS REPROGRAMMED TO DECREASE THE SENSITIVITY, THEN CAPPED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23412112 ↗
• MalfunctionOct 22, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DISLODGED THREE DAYS POST IMPLANT. THE RV LEAD WAS REMOVED AND REPLACED. THE SECOND RV LEAD WAS NOTED TO EXHIBIT HIGH IMPEDANCES DURING POSITIONING. THE SECOND 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 23359702 ↗
• MalfunctionAug 6, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED DURING AN IMPLANT PROCEDURE OF THE LEAD, THAT THE LEAD EXHIBITED HELIX EXTENSION/RETRACTION ISSUE. THE HELIX EXHIBITED TOO MANY TURNS TO EXTEND/RETRACT (NOT BLOCKED). THE LEAD WAS ATTEMPTED, NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22726866 ↗
• MalfunctionJul 29, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN. IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R WAVE OVERSENSING ON SEVERAL ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES. THE LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain

  MAUDE report 22644386 ↗
• MalfunctionJul 17, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING. THE LEAD REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22529336 ↗