Evera MRI™ XT DR SureScan® DDMB1D4 (UDI 00643169720497)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,426 adverse event reports that list this exact device (DI 00643169720497), received between Apr 10, 2018 and Sep 28, 2026 — classified as 35 deaths, 1,058 injuries, 333 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (525 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-1712-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,426 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50916113 ↗
• InjurySep 16, 2026Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50796442 ↗
• InjurySep 16, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the patient received Anti-Tachycardia Pacing (ATP) and high voltage therapy from the Implantable Cardioverter Defibrillator (ICD) for possible Supra Ventricular Tachycardia (SVT) or Atrial Tachycardia/Atrial Fibrillation (AT/AF) with fast ventricular response that the device 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 50788170 ↗
• DeathSep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported by the patient's spouse that the patient passed away. The spouse indicated that the patient passed due to the patient going into kidney failure after an unknown procedure.

  Patient problems: Renal Failure

  MAUDE report 50786685 ↗
• InjurySep 4, 2026Inappropriate/Inadequate Shock/Stimulation; Protective Measures Problem; Unauthorized Access to Computer System

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50619317 ↗
• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Discomfort; Fever; Unspecified Infection

  MAUDE report 50594028 ↗
• MalfunctionSep 2, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569853 ↗
• InjuryAug 25, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the patient received a possible inappropriate shock for an episode of Atrial Tachycardia/Atrial Fibrillation (AT/AF) with Rapid Ventricular Response that the Implantable Cardioverter Defibrillator (ICD) detected as Ventricular Fibrillation (VF). Additionally the ICD detected an episode of Supra Ventricular Tachycardia (SVT) as Ventricular Tachycardia (VT). 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 50436649 ↗
• MalfunctionAug 20, 2026Signal Artifact/Noise; Electromagnetic Interference; Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50355039 ↗
• MalfunctionAug 11, 2026Electromagnetic Interference; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50211480 ↗
• InjuryAug 10, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the Right Atrial (RA) lead exhibited intermittent undersensing resulting in misclassification of Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) episode. In addition, the patient received inappropriate Anti-Tachycardia Pacing therapy and a shock for an episode detected in the Fast Ventricular Tachycardia (FVT) zone that was suspected to be Atrial Tachycardia/Atrial Fibrillation (AT/AF) with fast ventricular response. The Implantable Cardioverter Defibrillator (ICD) and RA lead 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 50195821 ↗
• MalfunctionAug 7, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50176979 ↗
• InjuryAug 4, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the Implantable Cardioverter Defibrillator (ICD) was explanted and replaced due to an unspecified performance issue. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50135746 ↗
• InjuryJul 7, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POSSIBLY DELIVERED AN INAPPROPRIATE SHOCK FOR SINUS TACHYCARDIA. THE ICD DETECTED THE EPISODE AS VENTRICULAR TACHYCARDIA (VT). 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 25732052 ↗
• InjuryJun 26, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE (RVR) DETECTED AS VENTRICULAR FIBRILLATION (VF). IT WAS FURTHER REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) FOR AT/AF WITH RVR DETECTED AS FAST VENTRICULAR TACHYCARDIA (FVT). ADDITIONALLY, AT/AF WITH RVR WAS DETECTED AS NON-SUSTAINED VENTRICULAR TACHYCARDIA. 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 25640279 ↗
• InjuryJun 26, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCKED FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE WHICH THE DEVICE DETECTED AND TREATED AS VENTRICULAR TACHYCARDIA (VT). IN ADDITION THE DEVICE MIS-DETECTED SUPRA VENTRICULAR TACHYCARDIA (SVT) FOR VT.  THE DEVICE HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT) AND HAS BEEN EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25640110 ↗
• InjuryJun 23, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS FOR AN EPISODE DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE THAT WAS SUSPECTED TO BE ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE OR SUPRA VENTRICULAR TACHYCARDIA (SVT). IN ADDITION, THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING AT/AF STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS. ADDITIONALLY, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. 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 25598798 ↗
• InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 25487287 ↗
• MalfunctionJun 9, 2026Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. ADDITIONALLY, THE PATIENT RECEIVED ANTI-TACHYCARDIA PACING (ATP) THERAPY FOR AN EPISODE OF VENTRICULAR TACHYCARDIA (VT) DETECTED AS VENTRICULAR FIBRILLATION (VF). THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) 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 25449516 ↗
• MalfunctionJun 8, 2026Over-Sensing

  IT WAS REPORTED THAT THE A LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED DUE TO HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC) DURING SURGERY. IT WAS NOTED THAT THE EPISODES SUGGEST A MAGNET WAS NOT USED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) 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 25438058 ↗
• InjuryJun 8, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING THERAPY AND A SHOCK FOR AN EPISODE DETECTED IN THE VENTRICULAR TACHYCARDIA (VT) ZONE THAT WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT). 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 25436318 ↗
• MalfunctionJun 3, 2026Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR A DETECTED VENTRICULAR TACHYCARDIA (VT) EPISODE. 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 25377440 ↗
• InjuryMay 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. VEGETATION WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection

  MAUDE report 25322831 ↗
• MalfunctionMay 27, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED AN EPISODE OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE AS VENTRICULAR TACHYCARDIA (VT). THE ICD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEENREPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25306674 ↗
• InjuryMay 19, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEY WERE EXPERIENCING "ISSUES" WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SINCE "A SENSOR WAS TURNED ON". THE PATIENT HAS EXPERIENCED CHEST PAIN EVERYDAY. THE PATIENT CROSSES CARGO TRAIN TRACKS TO GET TO WORK AND EXPERIENCES CHEST PAIN. THE PATIENT REPORTED "PRIOR TO TURNING ON THE SENSOR NO ISSUES". "THEY HAVE CHANGED IT FROM HIGH TO MEDIUM NOW LOW BUT IT HURTS SO BAD". ADDITIONALLY, THE PATIENT REPORTED PAIN WHEN DRIVING THROUGH A TUNNEL. THE DEVICE WAS REPROGRAMMED TO HELP WITH INTERFERENCE AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain; Pain

  MAUDE report 25221632 ↗