SelectSecure™ MRI SureScan™ 383074 (UDI 00643169857698)Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00643169857698), received between Apr 10, 2018 and Apr 9, 2026 — classified as 2 deaths, 19 injuries, 10 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (11 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 31 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2026Capturing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) HIS BUNDLE LEAD EXHIBITED RISING 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 24825991 ↗
• InjuryJul 23, 2025Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE. IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING ON A SINGLE BEAT WHICH RESULTED IN INAPPROPRIATE PACING. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 22573779 ↗
• MalfunctionMay 15, 2025Capturing Problem; High Capture Threshold; Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED POSSIBLE CAPTURE ISSUE WITH HIGH THRESHOLD. 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 22027775 ↗
• InjuryJan 30, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) HIS BUNDLE LEAD EXHIBITED HIGH THRESHOLDS. THE RV HIS BUNDLE 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 21272116 ↗
• MalfunctionFeb 23, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE HIS BUNDLE LEAD EXHIBITED HIGH HIS BUNDLE THRESHOLDS. THE HIS BUNDLE 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 18766219 ↗
• InjuryDec 7, 2023High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HIS BUNDLE 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 18280934 ↗
• MalfunctionAug 11, 2023High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) HIS BUNDLE LEAD EXHIBITED HIGH THRESHOLDS. THE LEAD REMAINS IN USE. NO PATIENT COMPL ICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17508263 ↗
• InjuryMay 30, 2023Capturing Problem; High Capture Threshold; Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR HIS BUNDLE (RV) LEAD EXHIBITED A SPIKE IN THRESHOLDS AND ELEVATED THRESHOLDS. THE RV HIS BUNDLE 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 17018110 ↗
• InjuryDec 14, 2022High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH 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 15975404 ↗
• InjuryJul 6, 2022Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT WAS FEELING LIGHTHEADED AND THE PHYSICIAN NOTICED IRREGULARITIES IN THE ELECTROCARDIOGRAM (EKG) AND THOUGHT THERE MAY NOT HAVE BEEN CAPTURE. FOLLOW-UP WITH THE CLINIC INDICATED THE HIS BUNDLE LEAD WAS REPROGRAMMED TO INCREASE THE PROGRAMMED OUTPUT AND THERE WAS NO LOSS OF CAPTURE NOTED AS THE PATIENT HAD BACK-UP RIGHT VENTRICULAR (RV) LEAD PACING. THE HIS BUNDLE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 14932425 ↗
• MalfunctionJan 24, 2022High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT, THE RIGHT VENTRICULAR (RV) HIS BUNDLE LEAD, POST REPROGRAMMING, EXHIBITED HIGH THRESHOLDS/OUTPUT. IT WAS ALSO REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PRE-MATURE BATTERY DEPLETION, WHERE THE BATTERY LONGEVITY DECREASED BY APPROXIMATELY THREE YEARS, IN AN APPROXIMATE FOUR MONTH PERIOD. BOTH THE RV HIS BUNDLE LEAD AND IPG 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 13332677 ↗
• InjurySep 24, 2021Failure to Capture; Under-Sensing; Failure to Capture; Under-Sensing

  IT WAS FURTHER REPORTED THAT THE LEADS WERE REPROGRAMMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12524808 ↗
• InjurySep 13, 2021Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) HIS-BUNDLE LEAD EXHIBITED NO CAPTURE. THE RV HIS-BUNDLE 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 12459564 ↗
• InjuryMay 26, 2021Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT LOSS OF CAPTURE WAS NOTED ON THE HIS BUNDLE LEAD. 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 11883415 ↗
• InjuryAug 21, 2020Capturing Problem; High Capture Threshold; Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) HIS BUNDLE LEAD EXHIBITED RISING AND HIGH THRESHOLDS. THE PHYSICIAN DECIDED DUE TO THE HIGH THRESHOLD TO REMOVE AND REPLACE THE LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10435812 ↗
• InjuryJun 22, 2020Break; Failure to Capture; Low impedance; Break; Failure to Capture; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NON-CAPTURE, LOW IMPEDANCE AND A POSSIBLE INSULATION BREACH. REPROGRAMMING OCCURRED. THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10178417 ↗
• MalfunctionApr 9, 2020High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) HIS BUNDLE LEAD EXHIBITED OCCASIONAL ELEVATED THRESHOLDS. THE RV 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 9942591 ↗
• InjuryMar 31, 2020Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE HIS BUNDLE LEAD WAS NOT CAPTURING. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9902400 ↗
• InjuryApr 18, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY HAD "FLUID BUILD UP AROUND THEIR HEART", WHICH WAS CAUSING THEM PAIN AND THEY ARE FEELING ANXIOUS. THE PATIENT BELIEVES THEIR RIGHT VENTRICULAR (RV) LEAD IS NOT CONNECTED PROPERLY AND THAT THE LEAD HAS DISCONNECTED FROM THE IMPLANTABLE PULSE GENERATOR (IPG). THE LEAD AND DEVICE REMAINS IN USE. THE PATIENT REPORTED THAT THIS HAD HAPPENED ALSO WITH PREVIOUSLY IMPLANTED RIGHT VENTRICULAR (RV) LEAD WHICH WAS THEN EXPLANTED AND REPLACED WITH THE CURRENT RV LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Anxiety; Pericardial Effusion

  MAUDE report 8527591 ↗
• InjuryMar 5, 2019Over-Sensing; Decreased Sensitivity; Over-Sensing; Decreased Sensitivity

  IT WAS REPORTED THAT THERE WAS AN ALERT FOR HIGH SHORT VENTRICULAR INTERVALS ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS ALSO NOTED THERE WERE SMALL R WAVES AND OVERSENSING DURING VENTRICULAR TACHYCARDIA (VT) EPISODES. FOLLOW UP CONCLUDED THAT THE RV LEAD WAS REPROGRAMMED AND 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 8390123 ↗
• MalfunctionFeb 19, 2019Capturing Problem; Adverse Event Without Identified Device or Use Problem; Capturing Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHORTNESS OF BREATH AND DIZZINESS A FEW DAYS AFTER SNOWBLOWING. AN INTERROGATIONS REVEALED THE RIGHT VENTRICULAR (RV) LEAD THRESHOLDS INCREASED TO HIGH LEVELS. THE PHYSICIAN ATTEMPTED TO IMPLANT AN ALTERNATE RV LEAD BUT WAS UNABLE TO GET STABLE LEAD PLACEMENT WITH ACCEPTABLE THRESHOLDS. AN ALTERNATE RV LEAD WAS PLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8351065 ↗
• InjuryFeb 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PUS IN THE POCKET AND AN INFECTION. THE DEVICE AND LEADS WERE EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8327368 ↗
• MalfunctionFeb 5, 2019Failure to Capture; High Capture Threshold; Unstable Capture Threshold; Failure to Capture; High Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT DURING ATTEMPTS TO IMPLANT THE RIGHT VENTRICULAR (RV) LEAD HIGH THRESHOLDS, UNSTABLE THRESHOLDS AND NO CAPTURE WERE OBSERVED. THE RV LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8308592 ↗
• MalfunctionFeb 5, 2019High impedance; Failure to Sense; High impedance; Failure to Sense

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DURING IMPLANT WAS NOT SENSING AND HAD HIGH IMPEDANCE. THE RV LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8308480 ↗
• InjuryJan 31, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8291927 ↗