CapSure Sense MRI™ SureScan™ 457453 (UDI 00643169410961)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00643169410961), received between Apr 25, 2018 and Mar 6, 2026 — classified as 6 injuries, 8 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO INFECTION NOTED AS ENDOCADITIS.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis

  MAUDE report 24531490 ↗
• InjuryFeb 24, 2025Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED RISING THRESHOLDS. 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 21443557 ↗
• MalfunctionNov 10, 2023Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS ON STORED ELECTROGRAMS (EGM). 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 18108572 ↗
• InjuryFeb 18, 2022High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS. THE RA LEAD WAS 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 13557616 ↗
• MalfunctionJul 15, 2020High Capture Threshold; High Capture Threshold

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10275088 ↗
• InjuryJan 22, 2020High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED CHRONICALLY HIGH THRESHOLDS SINCE IMPLANT. REPROGRAMMING OCCURRED. THE LEAD WAS SUBSEQUENTLY EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9614914 ↗
• InjuryDec 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AND REQUIRED ANTIBIOTIC TREATMENT. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9529652 ↗
• MalfunctionDec 11, 2019Under-Sensing; Under-Sensing

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9450128 ↗
• MalfunctionAug 6, 2019High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS. THE RA LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8864037 ↗
• MalfunctionNov 6, 2018Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT INTERMITTENT ATRIAL OVERSENSING WAS NOTED ON PRESENTING ELECTROGRAM. THE RA LEAD REMAINS IN USE. NO PATIENT COM PLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8044462 ↗
• MalfunctionOct 17, 2018High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCES POST OPERATIVELY. FOLLOW UP FROM THE REP CONFIRMED THAT THE IMPEDANCES WERE ALL WITHIN LIMITS UPON A MANUAL INTERROGATION AND NO INTERVENTION WAS NEEDED ON THIS PATIENT. BOTH RA AND RV LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7974130 ↗
• InjuryJul 19, 2018Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD DISLODGED ONE DAY AFTER THE IMPLANT PROCEDURE. THE LEAD WAS REPOSITIONED BACK TO ITS ORIGINAL POSITION. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7704700 ↗
• MalfunctionMay 14, 2018Under-Sensing; Under-Sensing

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7510222 ↗
• MalfunctionApr 25, 2018Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OCCASIONAL UNDERSENSING DURING AN EPISODE OF ATRIAL ARRHYTHMIA. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7461431 ↗