SelectSecure™ MRI SureScan™ 383069 (UDI 00643169857681)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,516 adverse event reports that list this exact device (DI 00643169857681), received between Aug 9, 2017 and Sep 30, 2026 — classified as 9 deaths, 998 injuries, 509 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (677 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,516 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Over-Sensing

  It was reported that the Right Ventricular (RV) HIS Bundle lead exhibited cross chamber 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 50945252 ↗
• MalfunctionSep 29, 2026Over-Sensing; Pacing Problem; Under-Sensing; High Capture Threshold

  It was reported that the Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing triggering AT/AF episode misclassification. It was also reported that the Right Ventricular (RV) lead exhibited undersensing leading to overpacing on Atrial Tachycardia/A trial Fibrillation (AT/AF) episodes, oversensing on the ventricular lead resulting in misclassification of episode type and high thresholds. The RA lead and RV 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 50929805 ↗
• MalfunctionSep 14, 2026Over-Sensing; High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited a large number of Sensing Integrity Counter (SIC), cross chamber oversensing, and chronic high thresholds post reprogramming. A possible setscrew issue was suspected. The IPG and RV 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 50752814 ↗
• MalfunctionSep 10, 2026Signal Artifact/Noise; Over-Sensing; High Capture Threshold

  It was reported that the Right Ventricular (RV) lead oversensing , high short V-V interval Sensing Integrity Counter (SIC) count , high thresholds and noise. 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 50710914 ↗
• InjurySep 9, 2026Capturing Problem

  It was reported that the His Bundle Right Ventricular (RV) lead exhibited rising thresholds. The His Bundle RV 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 50690681 ↗
• MalfunctionSep 8, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50675941 ↗
• InjurySep 4, 2026Device Dislodged or Dislocated

  It was reported that the patient experienced syncope. It was further reported that the Right Ventricular (RV) lead dislodged. The lead was capped and replaced. No patient complications have been reported as a result of this event.

  Patient problems: Syncope/Fainting

  MAUDE report 50606581 ↗
• InjuryAug 25, 2026Intermittent Capture; Capturing Problem; High Capture Threshold

  It was reported that the Right Ventricular (RV) HIS bundle lead exhibited rising and high thresholds and intermittent capture. 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 50427355 ↗
• MalfunctionAug 21, 2026Pacing Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50367396 ↗
• MalfunctionAug 12, 2026Pacing Problem; Decreased Sensitivity

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50222643 ↗
• InjuryAug 11, 2026Fracture; Over-Sensing; High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited high thresholds, increased short v-v intervals, noise and was fractured. The 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 50207970 ↗
• MalfunctionJul 9, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING RESULTING IN INAPPPROPRIATE PACING. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain

  MAUDE report 25759052 ↗
• MalfunctionJun 25, 2026Degraded

  IT WAS REPORTED THAT THE LOW VOLTAGE PORTION OF THE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WAS SUSPECTED TO HAVE FRACTURED. THE LEAD WAS EXPLANTED AND REPLACED. IT WAS FURTHER REPORTED THAT THE LEAD WAS RETURNED TO THE MANUFACTURER AFTER BEING PROPHYLACTICALLY REPLACED AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25620440 ↗
• MalfunctionJun 15, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW AMPLITUDE R WAVES AND UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS AND UNNECESSARY PACING IN THE VENTRICLE. 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 25503807 ↗
• InjuryJun 4, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) HIS BUNDLE LEAD EXHIBITED HIGH THRESHOLDS. THE RV HIS BUNDLE LEAD WAS CAPPED AND WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25391787 ↗
• MalfunctionJun 2, 2026Over-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) HIS LEAD EXHIBITED UNDERSENSING RESULTING IN OVER-PACING ALONG WITH SHORT V-V INTERVALS. 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 25367552 ↗
• MalfunctionMay 27, 2026Failure to Capture; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIZZINESS AND NEAR SYNCOPE. THE RIGHT VENTRICULAR (RV) HIS BUNDLE LEAD EXHIBITED LOSS OF CAPTURE AND UNDERSENSING RESULTING IN INAPPROPRIATE PACING. THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING. THE RV HIS BUNDLE LEAD AND THE RA LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; Presyncope

  MAUDE report 25298307 ↗
• MalfunctionMay 25, 2026Low impedance

  IT WAS REPORTED THAT THE HIS BUNDLE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A LOW IMPEDANCE WARNING. THE HIS BUNDLE 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 25270170 ↗
• MalfunctionMay 21, 2026Failure to Capture; Under-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS, LOSS OF CAPTURE AND UNDERSENISNG. THE RIGHT ATRIAL (RA) LEAD ALSO EXHIBITED AN LEAD POSITION CHECK FAIL. BOTH LEADS 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 25243354 ↗
• MalfunctionMay 14, 2026Low impedance; Impedance Problem

  IT WAS FURTHER REPORTED THAT THE LV LEAD EXHIBITED LOW IMPEDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25173483 ↗
• MalfunctionMay 14, 2026Low impedance; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) HIS BUNDLE LEAD EXHIBITED A LOW IMPEDANCE WARNING 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 25169563 ↗
• MalfunctionMay 14, 2026Failure to Capture; Under-Sensing

  IT WAS NOTED THAT THE RV LEAD UNDERSENSING WAS FUNCTIONAL AND DUE TO PREMATURE VENTRICULAR CONTRACTIONS (PVC).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25169526 ↗
• MalfunctionApr 24, 2026Over-Sensing; Pacing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED NOISE. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) HIS BUNDLE LEAD EXHIBITED HIGH THRESHOLDS, SHORT V-V INTERVALS AND OVERSENSING ON THE VENTRICULAR LEAD RESULTING IN INHIBITION OF PACING AND MISCLASSIFICATION OF EPISODE TYPE. THE IPG SYSTEM 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 24977965 ↗
• InjuryApr 21, 2026Failure to Capture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DISLODGED AND EXHIBITED NO 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; Presyncope

  MAUDE report 24936880 ↗
• InjuryApr 14, 2026High Capture Threshold

  IT WAS REPORTED THAT THE LEFT BUNDLE BRANCH (LBB) LEAD EXHIBITED SLIGHTLY ELEVATED THRESHOLDS. THE LBB 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 24870029 ↗