SelectSecure™ MRI SureScan™ 383074 (UDI 00763000740276)Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00763000740276), received between Jul 17, 2023 and Sep 29, 2026 — classified as 34 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (12 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 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Over-Sensing

  It was reported that the patient expeirenced dyspnea and arm pain. It was further 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: Dyspnea; Pain

  MAUDE report 50931052 ↗
• MalfunctionSep 28, 2026Impedance Problem; Positioning Problem

  It was reported that during an upgrade procedure, the Left Ventricular (LV) lead was unable to be inserted and the impedances started at a thousand "and didn't get very far". The patient had sarcoids so it was known that they would have a difficult septum to drill into. The procedure was abandoned. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914886 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Right Ventricular (RV) left bundle branch lead was explanted and replaced due to decreased ejection fraction. No patient complications have been reported as a result of this event.

  Patient problems: Low Cardiac Output

  MAUDE report 50820526 ↗
• InjuryAug 31, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that following a device changeout and Left Bundle Branch (LBB) lead implant procedure the Right Ventricular (RV) lead exhibited Out of Range (OOR) low pacing impedance. After going back into the pocket, it was discovered that that there was a loose lead connection with the Cardiac Resynchronization Therapy Defibrillator (CRT-D). The RV lead was reconnected to the CRT-D and remains in use with stable impedances observed. It was also noted that the LBB lead had ¿issues¿ and repositioning of the lead was also attempted. The LBB 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 50531372 ↗
• InjuryAug 20, 2026Device Dislodged or Dislocated

  It was reported that four days post implant, the Right Ventricular (RV) Left Bundle Branch (LBB) lead became dislodged. The RVLBB lead was explanted 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 50343937 ↗
• MalfunctionAug 13, 2026Capturing Problem; Impedance Problem

  It was reported that  acute increase in R-wave amplitude., an acute decrease in Right Ventricular (RV) lead thresholds and acute increase and decrease in RV impedances. The Left Bundle Branch (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 50232811 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that that approximately two weeks post-implant the patient's pocket wound separated. The patient experienced a pocket infection, pocket erosion, discomfort, pain, redness, swelling, and wound dehiscence. 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: Discomfort; Erythema; Medical device site infection; Pain; Pocket Erosion; Swelling/ Edema; Wound Dehiscence

  MAUDE report 50155896 ↗
• MalfunctionJul 1, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PACING BELOW PROGRAMMED LOWER RATE LIMIT. IT WAS FURTHER NOTED THAT THE RIGHT VENTRICULAR (RV) LEFT BUNDLE BRANCH (LBB) LEAD EXHIBITED T-WAVE OVERSENSING. THE IPG AND LBB LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 25678007 ↗
• InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POCKET INFECTION WITH REDNESS. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Medical device site infection

  MAUDE report 25482423 ↗
• MalfunctionMay 6, 2026Positioning Problem

  IT WAS REPORTED THAT DURING IMPLANT THE PACING LEAD WOULD NOT ADVANCE INTO SEPTAL TISSUE, DESPITE MULTIPLE ROTATIONS OF THE LEAD. THE 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 25093637 ↗
• InjuryApr 15, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT LEFT BUNDLE BRANCH (LBB) RIGHT VENTRICULAR (RV) LEAD DISLODGED POST POCKET CLOSURE. THE LBB 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 24886031 ↗
• MalfunctionMar 26, 2026Failure to Capture; Pacing Problem; Under-Sensing; Decreased Sensitivity; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT BUNDLE BRANCH RIGHT VENTRICULAR (RV) LEAD EXHIBITED RIGHT DIMINISHED SENSING, UNDER SENSING, INAPPROPRIATE PACING, HIGH THRESHOLDS AND LOSS OF CAPTURE. THE RV LEAD REMAINS I USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24696854 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT REPRESENTATIVE THAT THE PATIENT EXPERIENCED AN INFECTION OF THE IMPLANTABLE PULSE GENERATOR (IPG) SYS TEM. IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE EMERGENCY VISITS UNTIL THE CLINIC FOUND THE BLOOD INFECTION ON THE IPG SYSTEM AND THE VALVE, AND THAT THE PATIENT WAS GETTING WEAKER AND WEAKER, AND EXPERIENCED "CRITICAL MINISTROKES". THE IPG SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Muscle Weakness/Atrophy; Transient Ischemic Attack; Unspecified Infection

  MAUDE report 24580664 ↗
• InjuryMar 6, 2026High impedance; Connection Problem

  IT WAS REPORTED THAT THE LOW POWERED RIGHT VENTRICULAR (RV) LEAD PLACED IN THE LEFT BUNDLE BRANCH (LBB) EXHIBITED UNDEFINED HIGH PACING IMPEDANCE AND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS REPROGRAMMED. THE FOLLOWING DAY, THE PHYSICIAN OPENED THE DEVICE POCKET TO FIND THAT THE RV LEAD WAS NOT SEATED IN THE DEVICE HEADER AND ¿COMPLETELY CAME OUT OF THE HEADER¿ WHEN THE DEVICE WAS REMOVED FROM THE POCKET. THE RV LEAD WAS TESTED WITH AN ANALYZER, HAD NORMAL VALUES, AND WAS RE-CONNECTED TO THE DEVICE. IT WAS THEN NOTICED THAT SINCE THE PHYSICIAN HAD REMOVED THE DEVICE FROM THE POCKET, THE RIGHT ATRIAL (RA) LEAD SLACK HAD BEEN PULLED. THE RA LEAD WAS THEN DISCONNECTED FROM THE DEVICE, SLACK WAS ADDED BACK TO THE LEAD, AND PARAMETERS TESTED ON THE ANALYZER WERE NORMAL. HOWEVER, WHEN ATTEMPTING TO RE-CONNECT THE RA LEAD BACK INTO THE HEADER, THE PHYSICIAN WAS UNABLE TO ENGAGE THE SETSCREW. THE PHYSICIAN ATTEMPTED A NEW SETSCREW WHICH WAS ABLE TO CONNECT THE RA LEAD, BUT BEFORE PUTTING THE NEW SETSCREW INTO THE RA LEAD PORT, THE PHYSICIAN HAD PULLED THE GROMMET OUT OF THE DEVICE HEADER. DUE TO THE GROMMET BEING PULLED OFF, THE RA LEAD EXHIBITED NOISE. A NEW DEVICE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24537248 ↗
• InjuryMar 2, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD, RIGHT ATRIAL (RA) LEAD, AND LEFT BUNDLE BRANCH BLOCK (LBBB) LEAD BECAME DISLODGED DUE TO TWIDDLER'S SYNDROME. IN ADDITION, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BECAME ROTATED. THE RV LEAD WAS EXPLANTED AND REPLACED. THE LBBB LEAD WAS EXPLANTED AND A PIN PLUG PLACED IN THE LV PORT. THE RA LEAD AND CRT-D REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Twiddlers Syndrome

  MAUDE report 24489378 ↗
• InjuryFeb 23, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THE RIGHT VENTRICULAR (RV) LEAD "WASN'T WORKING, SO THEY HAD TO REMOVE THAT". 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 24416206 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO THE PATIENT EXPERIENCING SEPTIC SHOCK AND A HEART FAILURE EXACERBATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Heart Failure/Congestive Heart Failure; Sepsis; Septic Shock; Unspecified Infection

  MAUDE report 24309453 ↗
• MalfunctionFeb 6, 2026Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT BUNDLE BRANCH LEAD HAD HIGH THRESHOLD, OVERSENSING, AND ELEVATED SHORT VENTRICULAR INTERVALS. IT WAS ALSO NOTED THERE WAS RIGHT ATRIAL (RA) LEAD UNDERSENSING DURING STORED ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES THAT RESULTED IN UNNECESSARY PACING. THE PATIENT LATER DIED IN A MANNER UNRELATED TO THE DEVICE SYSTEM PERFORMANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24278321 ↗
• InjuryFeb 3, 2026Material Integrity Problem

  IT WAS REPORTED THAT APPROXIMATELY SIX WEEKS POST-IMPLANT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS AND UNDERSENSING. DURING THE EXPLANT PROCEDURE THE RIGHT VENTRICULAR (RV) LEFT BUNDLE BRANCH (LBB) LEAD WAS DAMAGED. BOTH LEADS WERE 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 24245876 ↗
• InjuryJan 30, 2026High Capture Threshold

  IT WAS REPORTED THAT 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 24220199 ↗
• InjuryJan 26, 2026Device Dislodged or Dislocated

  IT WAS REPORTED POST-OPERATIVELY THAT THE RIGHT ATRIAL (RA) LEAD AND THE LEFT BUNDLE BRANCH (LBB) RIGHT VENTRICULAR (RV) LEAD EXHIBITED A DISLODGEMENT. THE RA AND RV LEADS WERE 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 24178208 ↗
• InjuryJan 5, 2026Intermittent Capture; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ASYSTOLE AND SYNCOPE. IT WAS NOTED THERE WAS INTERMITTENT LOSS OF CAPTURE AND HIGH THRESHOLDS ON THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Asystole; Syncope/Fainting

  MAUDE report 23959504 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE WEEKS POST IMPLANT THAT THE PATIENT DEVELOPED AN INFECTION. THERE WAS ALSO REDNESS, SWELLING AND EROSION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED AND REPLACED A FEW DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Erythema; Swelling/ Edema; Unspecified Infection

  MAUDE report 23847924 ↗
• InjuryDec 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEFT BUNDLE BRANCH LEAD MICRO DISLODGED. 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 23801178 ↗
• InjuryNov 18, 2025Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS NOTED THAT THE RV LBB LEAD WAS REPROGRAMMED.

  Patient problems: Cardiac Arrest

  MAUDE report 23581684 ↗