SelectSecure™ MRI SureScan™ 383069 (UDI 00763000740269)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5,027 adverse event reports that list this exact device (DI 00763000740269), received between Apr 25, 2023 and Sep 30, 2026 — classified as 50 deaths, 3,167 injuries, 1,810 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1,112 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 5,027 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Pacing Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948411 ↗
• InjurySep 30, 2026High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947987 ↗
• InjurySep 30, 2026Capturing Problem; High Capture Threshold

  It was reported that the Right Ventricular Left Bundle Branch (RV-LBB) lead exhibited high thresholds and rising thresholds. The lead was reprogrammed and later 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 50947358 ↗
• MalfunctionSep 30, 2026Positioning Problem

  It was reported that intra-operatively two pacing leads had tissue built up in the helix. Both leads were not used and were replaced. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947221 ↗
• MalfunctionSep 30, 2026Positioning Problem

  It was reported that intra-operatively two pacing leads had tissue built up in the helix. Both leads were not used and were replaced. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947203 ↗
• InjurySep 30, 2026Failure to Capture; Device Dislodged or Dislocated; High Capture Threshold

  It was reported that seven weeks post implant the Right Atrial (RA) lead and Right Ventricular (RV) Left Bundle Branch (LBB) lead dislodged. The RV LBB lead exhibited high thresholds and intermittent capture. The RA lead exhibited no capture and no sensing. The physician was suspicious of Twiddler's Syndrome due to the lack of slack and possible twists in the leads seen on x-ray. Upon opening the pocket, knots were seen in the lead coils, indicating the dislodgement was due to Twiddlers' Syndrome. The RV LBB lead was reprogrammed. The RA lead and RV LBB leads were explanted and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Twiddlers Syndrome

  MAUDE report 50946253 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 50945982 ↗
• MalfunctionSep 30, 2026Pacing Problem; Under-Sensing

  It was reported that the Right Atrial (RA) lead and Right Ventricular (RV) left bundle branch lead exhibited undersensing and unnecessary pacing. 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 50945392 ↗
• MalfunctionSep 30, 2026Over-Sensing

  It was reported that the patient experienced a low heart rate. It was also reported that the Right Ventricular (RV) lead exhibited T-Wave Oversensing (TWOS). The lead remains in use. No patient complications have been reported as a result of this event.

  Patient problems: Bradycardia

  MAUDE report 50945068 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced a medical device site infection, discomfort, purulent discharge and bacteremia. The Imp lantable Pulse Generator (IPG) system was explanted. No further patient complications have been reported as a result of this event.

  Patient problems: Discomfort; Drug Resistant Bacterial Infection; Medical device site infection; Purulent Discharge

  MAUDE report 50944306 ↗
• MalfunctionSep 30, 2026Signal Artifact/Noise; Over-Sensing

  It was reported that the patient was hospitalized. It was further reported that the Right Ventricular (RV) lead exhibited oversensing 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 50944296 ↗
• MalfunctionSep 29, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934395 ↗
• InjurySep 29, 2026High Capture Threshold

  It was reported that the Right Ventricular (RV) ¿ Left Bundle Branch (LBB) lead exhibited high thresholds. The RV-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 50933418 ↗
• MalfunctionSep 29, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932034 ↗
• MalfunctionSep 29, 2026Over-Sensing

  It was reported that the Right Ventricular (RV) Left Bundle Branch lead exhibited T-Wave Oversensing (TWOS). 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 50930977 ↗
• MalfunctionSep 29, 2026Break; Material Split, Cut or Torn

  It was reported during implant that the Right Ventricular (RV) lead exhibited insulation damage and cut insulation on the lead. The RV lead was attempted not used and replaced. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930899 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported approximately two month post implant that the patient experienced endocarditis and a Streptococcus gallolyticus infection. The Implantable Pulse Generator (IPG) system was explanted. No further patient complications have been reported as a result of this event.

  Patient problems: Bacterial Infection; Endocarditis

  MAUDE report 50930629 ↗
• MalfunctionSep 29, 2026Stretched; Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930465 ↗
• MalfunctionSep 29, 2026High impedance; Positioning Problem; High Capture Threshold

  It was reported during implant that the Right Ventricular (RV) lead exhibited tissue on the helix after five attempts at implantation, one further attempt was carried out but impedance and thresholds remained high. The RV lead was attempted not used and replaced. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930251 ↗
• MalfunctionSep 29, 2026Pacing Problem; Under-Sensing

  It was reported that the Left Bundle Branch Right Ventricular (RV) lead exhibited under sensing, resulting in over pacing. The LBB 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 50928537 ↗
• MalfunctionSep 28, 2026Over-Sensing

  It was reported that the patient experienced their heart rate being in the forties and fifties. It was also reported that the Right Ventricular (RV) lead exhibited T-wave oversensing (TWOS). The lead remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Bradycardia

  MAUDE report 50916929 ↗
• InjurySep 28, 2026Failure to Capture; High impedance; Over-Sensing; Under-Sensing; Capturing Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; High Capture Threshold; Unstable Capture Threshold

  It was reported that approximately three weeks post implant of an Implantable Pulse Generator (IPG) system, the patient experienced asystole, which seen from the ambulance electrocardiogram (ECG) recording when they were hooked up to an external pacer. The patient also experienced bradycardia, dizziness and pre-syncope. The Right Ventricular (RV) lead exhibited unstable thresholds, no capture, oversensing, short v-v intervals, cross talk oversensing, undersensing, high and rising thresholds and high impedance. A possible micro perforation was suspected and the lead had pulled back resulting in poor tissue interface. The RV lead was explanted and replaced. It was also noted that the Right Atrial (RA) lead exhibited cross talk oversensing. The lead remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Asystole; Bradycardia; Cardiac Perforation; Dizziness

  MAUDE report 50914834 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 50913024 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Fever; Unspecified Infection

  MAUDE report 50912979 ↗
• InjurySep 28, 2026Device Dislodged or Dislocated

  It was reported that the Right Ventricular (RV) lead dislodged post pocket closure. 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 50912674 ↗