Evera MRI™ XT DR SureScan™ DDMB1D1 (UDI 00643169837713)Recalls & reported problems

Summary

The FDA's MAUDE database contains 827 adverse event reports that list this exact device (DI 00643169837713), received between Apr 24, 2018 and Sep 25, 2026 — classified as 16 deaths, 527 injuries, 284 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (256 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 18, 2026.

Recalls naming this device

1. May 10, 2023Class IOpen, Classified

   There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.

   Z-1711-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 827 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Defibrillation/Stimulation Problem; Device Sensing Problem

  Patient problems: Tachycardia

  MAUDE report 50905136 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50887102 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Medical device site infection; Wound Dehiscence

  MAUDE report 50826961 ↗
• MalfunctionSep 17, 2026Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  It was reported that the Right Atrial (RA) lead exhibited oversensing resulting in misclassification of episode type and noise. The patient experienced an accident/trauma. The RA lead remains in use. Follow up with the clinic indicated that Electromagnetic Interference from the Implantable Cardioverter Defibrillator (ICD) was confirmed. No further actions were taken as a result of the event. The ICD remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50806197 ↗
• InjurySep 11, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) events resulting in unnecessary pacing at times and misclassification of episode type. The Implantable Cardioverter Defibrillator (ICD) de livered Anti-Tachycardia Pacing (ATP) and shocks for AT/AF with Rapid Ventricular Response (RVR) that was detected as Ventricular Tachycardia (VT). The ICD and lead remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50734012 ↗
• MalfunctionSep 9, 2026Electromagnetic Interference

  It was reported that there was Electromagnetic Interference on the atrial channel of the Implantable Cardioverter Defibrillator (ICD). The device 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 50693980 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) and Right Ventricular (RV) lead were explanted. The reason for explant was not reported. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50533373 ↗
• MalfunctionAug 26, 2026Signal Artifact/Noise; Electromagnetic Interference

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50454576 ↗
• InjuryAug 20, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the Right Ventricular (RV) lead exhibited undersensing. It was noted that there was no impact to overall device function or performance. It was further reported that the Implantable Cardioverter Defibrillator (ICD) delivered Anti-Tachycardia Pacing (ATP) and a shock for a detected Ventricular Fibrillation (VF) that was suspected to be Atrial Tachycardia/Atrial Fibrillation (AT/AF). It was noted that the device was in mode switch prior to detection. The RV lead and the ICD remain in use. No patient complications have been reported as a result of this event.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50336506 ↗
• MalfunctionAug 11, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50215264 ↗
• InjuryJul 31, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) events resulting in unnecessary pacing at times. Intermittent undersensing also resulted in misclassification of a detected Ventricular Tachycardia (VT) episode that was treated with Anti-Tachycardia Pacing (ATP) therapy. The RA lead remains in use. It was also reported that the patient received ATP and high voltage therapy from the Cardiac Resynchronization Therapy Defibrillator (CRT-D) for possible Atrial Tachycardia/Atrial Fibrillation (AT/AF) with fast ventricular response that the device detected as VT. There were also monitored episodes of possible AT/AF with fast ventricular response that were detected as Non-Sustained Ventricular Tachycardia. Functional undersensing in blanking/refractory on the ventricular channel also resulted in overpacing. The CRT-D remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50098384 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) system was explanted due to infection with bacteremia. There was vegetation observed on the tricuspid valve. No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia; Fever; Unspecified Infection

  MAUDE report 50086789 ↗
• MalfunctionJul 27, 2026Electromagnetic Interference; Pacing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50037335 ↗
• MalfunctionJul 13, 2026Electromagnetic Interference; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25797911 ↗
• InjuryJun 24, 2026Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT IS UNDER HOSPICE CARE AND THE ¿DEFIBRILLATOR KEEPS SHOCKING. THE MAGNET IS NOT WORKING, EVEN THOUGH IT IS TAPED. IT¿S BEEN GOING ON FOR PROBABLY A WEEK.¿ THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25610868 ↗
• DeathJun 24, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PATIENT PASSED OUT AND COLLAPSED AT DIALYSIS TREATMENT AND WENT INTO CARDIAC ARREST. THE PATIENT WAS RESUSCITATED BUT THEN WENT INTO PULSELESS ELECTRICAL ACTIVITY AND EXPIRED. IT WAS UNKNOWN IF THERE WAS A PRODUCT PERFORMANCE ISSUE. CAUSES OF DEATH PROVIDED WERE CONGESTIVE HEART FAILURE AND CHRONIC KIDNEY DISEASE. NO ADDITIONAL INFORMATION WAS REPORTED OR COULD BE OBTAINED.

  Patient problems: Cardiac Arrest; Heart Failure/Congestive Heart Failure; Renal Failure; Syncope/Fainting

  MAUDE report 25608518 ↗
• InjuryJun 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25549566 ↗
• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO INFECTION. THE RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS WERE PRESUMED TO BE TAKEN OUT OF SERVICE AS WELL; HOWEVER, THE STATUS OF THE LEADS IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25202968 ↗
• MalfunctionMay 11, 2026Electromagnetic Interference

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DIZZINESS AND NEAR SYNCOPE. THE RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING WITH ELECTROMAGNETIC INTERFERENCE OBSERVED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). ADDITIONALLY, THE RA LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) STORED EPISODES RESULTING IN TERMINATION OF DETECTED EVENTS IN PROGRESS. THE ICD, RA LEAD, AND RV LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; No Clinical Signs, Symptoms or Conditions; Presyncope

  MAUDE report 25136537 ↗
• InjuryMay 6, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING AND UNDERSENSING RESULTING IN POSSIBLE MISCLASSIFICATION OF EPISODE TYPE AND MAY HAVE LED TO ADDITIONAL THERAPIES DELIVERED. THE RV LEAD ALSO EXHIBITED T-WAVE OVERSENSING (TWOS),  THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCKED FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE WHICH THE DEVICE DETECTED AND TREATED AS VENTRICULAR FIBRILLATION (VF). THE LEAD  AND DEVICE REMAINS IN USED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25107404 ↗
• InjuryMay 5, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) MAY HAVE PROVIDED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FOR AN SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODE DETECTED AS VENTRICULAR FIBRILLATION (VF). THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25083477 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. A NEW ICD SYSTEM WAS IMPLANTED APPROXIMATELY A WEEK LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25019386 ↗
• InjuryMar 24, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT FOR CONGESTIVE HEART FAILURE, DIZZINESS, AND NEAR SYNCOPE. THE TRANSMISSION REPORT WAS REVIEWED AND IT WAS NOTED THAT THE PATIENT RECEIVED POSSIBLY INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND HIGH-VOLTAGE THERAPY FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CLASSIFIED AS VENTRICULAR FIBRILLATION (VF). THE DEVICE WAS NOTED TO BE AT END OF SERVICE (EOS); THEREFORE, THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; Heart Failure/Congestive Heart Failure; Presyncope; Shock from Patient Lead(s)

  MAUDE report 24681118 ↗
• InjuryMar 20, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCKS FOR VENTRICULAR TACHYCARDIA (VT) THAT WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT). IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING OF ATRIAL FIBRILLATION (AF) RESULTING IN INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP). REPROGRAMMING WAS DONE ON THE RA LEAD. THE ICD AND RA LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24654046 ↗
• InjuryMar 19, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POTENTIAL INAPPROPRIATE THERAPY DURING TREATED VENTRICULAR FIBRILLATION (VF), WHERE THERE WAS ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION IN PROGRESS AT THE TIME OF THE EPISODES. IN ADDITION, THERE WAS UNDERSENSING OBSERVED ONTHE RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24642952 ↗