SelectSecure™ MRI SureScan™ 383059 (UDI 00643169857674)Recalls & reported problems

Summary

The FDA's MAUDE database contains 133 adverse event reports that list this exact device (DI 00643169857674), received between Aug 15, 2017 and Sep 17, 2026 — classified as 74 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (45 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 133 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Under-Sensing

  It was reported that the Right Atrial (RA) lead exhibited undersensing resulting in termination of AT/AF detected event(s) in progress. 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 50802271 ↗
• InjurySep 3, 2026High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited 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 50584868 ↗
• MalfunctionSep 2, 2026Pacing Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50559963 ↗
• InjuryJun 24, 2026Intermittent Capture; Unstable Capture Threshold

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIZZINESS AND LOW HEART RATE. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT LOSS OF CAPTURE WITH UNSTABLE THRESHOLDS. THE RV LEAD WAS PARTIALLY EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Dizziness

  MAUDE report 25605398 ↗
• InjuryJun 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO A POCKET INFECTION. EROSION, PURULENT DISCHARGE/PUS, REDNESS, AND SWELLING WERE ALSO NOTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Erythema; Medical device site infection; Purulent Discharge; Swelling/ Edema

  MAUDE report 25525828 ↗
• MalfunctionMay 26, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT UNDERSENSING. 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 25275610 ↗
• InjuryMay 19, 2026Electrical /Electronic Property Problem; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE. THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING RESULTING IN UNNECESSARY PACING AT TIMES AND RESULTING IN TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) DETECTED EVENTS IN PROGRESS. LOW P WAVES WERE NOTED. THE RA LEAD WAS ALSO NOTED TO HAVE FAILED A LEAD POSITION CHECK. THE RA LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 25217842 ↗
• MalfunctionMay 12, 2026Electromagnetic Interference; Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT ATRIAL OVERSENSING ELECTROMAGNETIC INTERFERENCE (EMI) WERE OBSERVED ON STORED ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES WHICH RESULTED IN MISCLASSIFIED AT/AF. THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS AND FAR FIELD R-WAVE (FFRW) OVERSENSING. 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 25150054 ↗
• MalfunctionMay 7, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS AND UNNECESSARY ATRIAL 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 25109497 ↗
• MalfunctionApr 13, 2026Pacing Problem; Under-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WHICH RESULTED IN UNNECESSARY PACING AT TIMES. 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 24867212 ↗
• InjuryApr 8, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS "BROKEN" AND THAT IS WHY A NEW ICD SYSTEM WAS IMPLANTED AND THE OLD ICD SYSTEM REMAINS IN THE PATIENT'S BODY BUT INACTIVATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24817342 ↗
• MalfunctionMar 10, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING AT/AF STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS. 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 24558501 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS REMOVED DUE TO INFECTION THE MONTH FOLLOWING A GENERATOR REPLACEMENT PROCEDURE. A NEW PACEMAKER SYSTEM WAS IMPLANTED A FEW WEEKS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 23697727 ↗
• MalfunctionNov 27, 2025Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) 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 23665951 ↗
• MalfunctionNov 10, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES AT TIMES AND THE PATIENT HAD CHRONIC LOW P WAVES. THE RA LEAD REMAINS IN USE. THE ICD WAS LATER EXPLANTED AND REPLACED AFTER REACHING NORMAL RECOMMENDED REPLACEMENT TIME (RRT). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513993 ↗
• MalfunctionOct 28, 2025Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS AND POSSIBLE LOSS OF CAPTURE. 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 23403102 ↗
• MalfunctionSep 18, 2025Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACH YCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS AT TIMES AND INAPPROPRIATE PACING. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED TELEMETRY ISSUE AND THERE WERE MISSING SOME ELECTROGRAMS (EGM) DATA AND MARKER DATA. THE DEVICE AND LEAD REMAINS IN USE. NO PA TIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23087817 ↗
• MalfunctionMay 14, 2025Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THERE WAS INTERMITTENT RIGHT ATRIAL (RA) LEAD UNDERSENSING AND OVERSENSING NOTED ON PRESENTING 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 22019517 ↗
• MalfunctionJan 23, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACH YCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS 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 21222390 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) AND RIGHT VENTRICULAR (RV) HIS BUNDLE LEAD WERE EXPLANTED AND REPLACED. THE RIGHT ATRIAL (RA) LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 20427039 ↗
• MalfunctionAug 22, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT DURING THE IMPLANTABLE PULSE GENERATOR (IPG) CHANGE OUT PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS WHEN THE NEW DEVICE WAS CONNECTED. 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 20038995 ↗
• MalfunctionAug 8, 2024Failure to Capture; Under-Sensing; Failure to Capture; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD APPEARS TO BE UNDERSENSING WITH NO CAPTURE. THE LEAD REMAINS IN USE. NO PATIENT CO MPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19935869 ↗
• MalfunctionJul 2, 2024Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) HIS BUNDLE LEAD EXHIBITED OVERSENSING OF NON-PHYSIOLOGICAL NOISE AND MULTIPLE SHORT V-V INTERVAL COUNTS. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING RESULTING IN INAPPROPRIATE ATRIAL PACING AND FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) DETECTION. 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 19653098 ↗
• MalfunctionJun 7, 2024Break; Break

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD WERE 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 19491842 ↗
• MalfunctionJun 7, 2024Break; Break

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD WERE 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 19490166 ↗