Evera MRI™ XT VR SureScan® DVMB1D4 (UDI 00643169314153)Recalls & reported problems

Summary

The FDA's MAUDE database contains 272 adverse event reports that list this exact device (DI 00643169314153), received between Dec 9, 2016 and Jun 19, 2026 — classified as 7 deaths, 212 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (80 reports).

2 FDA recall records 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. Feb 3, 2021Class IOpen, Classified

   A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation

   Z-1305-2021 · Root cause: Device Design · Recall details · FDA record ↗

2. Dec 19, 2017Class ITerminated

   Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).

   Z-0585-2018 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 272 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2026Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO HIGH RATE NON-SUSTAINED EPISODES AND ELEVATED SENSING INTEGRITY COUNTER (SIC). THE LIA WAS A RESULT OF ELECTROMAGNETIC INTERFERENCE DURING A PROCEDURE WHERE CAUTERYWAS USED TO REPAIR A FISTULA. THE RV LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) 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 25565776 ↗
• InjuryApr 6, 2026Device Alarm System; Failure to Interrogate

  IT WAS FURTHER REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24792754 ↗
• InjuryFeb 18, 2026Defibrillation/Stimulation Problem; Low impedance

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED 10 HIGH-VOLTAGE SHOCKS FOR AN EPISODE DETECTED IN THE VENTRICULAR TACHYCARDIA (VT) ZONE. REVIEW OF THE EPISODE DATA SHOWED THAT AT LEAST FOUR OF THE HIGH-VOLTAGE THERAPIES EXPERIENCED SHORT-CIRCUIT PROTECTION (SCP) DURING THE FIRST PHASE OF DELIVERY, RESULTING IN LESS THAN THE PROGRAMMED HIGH-VOLTAGE ENERGY BEING DELIVERED. NOT ALL HIGH-VOLTAGE THERAPIES WERE ABLE TO BE REVIEWED DUE TO EPISODE DURATION AND DEVICE STORAGE LIMITATIONS, BUT THERAPIES FOR THE EVENT WERE CLASSIFIED OVERALL AS UNSUCCESSFUL AT TERMINATING THE RHYTHM. REVIEW OF THE DEVICE DATA ALSO SHOWED THAT FOLLOWING HIGH-VOLTAGE THERAPIES AND SCP EVENTS, ALERTS WERE TRIGGERED FOR LOW OUT OF RANGE (OOR) VENTRICULAR PACING LEAD IMPEDANCE ACROSS ALL PATHWAYS. THE ICD WAS LATER EXPLANTED AND REPLACED WITH A DUAL-CHAMBER SYSTEM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 24381752 ↗
• InjuryFeb 2, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED A POSSIBLE INAPPROPRIATE SHOCK FOR AN ATRIAL ARRHYTHMIA DETECTED AS VENTRICULAR FIBRILLATION (VF). THE DEVICE 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 24233926 ↗
• InjuryJan 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 SUPRA VENTRICULAR TACHYCARDIA (SVT) WHICH THE DEVICE DETECTED AND TREATED AS VENTRICULAR TACHYCARDIA (FVT). THE DEVICE 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 24178503 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL EXPERIENCING CHEST PAIN, COMPLETE HEART BLOCK, AND BRADYCARDIA. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS REPROGRAMMED TO INCREASE THE PATIENT'S RATE. THE ICD WAS LATER REMOVED AND UPGRADED TO A BI-VENTRICULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Chest Pain; Heart Block

  MAUDE report 23966797 ↗
• MalfunctionDec 10, 2025Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) THERAPY FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR A DEVICE-CLASSIFIED EPISODE OF VENTRICULAR FIBRILLATION (VF) DUE TO THE DEVICE DISCRIMINATOR NOT WITHHOLDING THERAPY. THE 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 23770777 ↗
• MalfunctionDec 8, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED AN ACUTE ISSUE. THE 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 23743830 ↗
• MalfunctionNov 25, 2025Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED AS VENTRICULAR TACHYCARDIA (VT). 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 23649048 ↗
• InjuryOct 15, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND AN INAPPROPRIATE SHOCK FOR VENTRICULAR FIBRILLATION (VF) 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 23304508 ↗
• InjurySep 5, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED ANTI-TACHYCARDIA PACING (ATP) AND SHOCKS THAT WERE POSSIBLY INAPPROPRIATE. THE EPISODES WERE INITIALLY DETECTED AS SUPRA VENTRICULAR TACHYCARDIA (SVT) AND THERAPY WAS APPROPRIATELY WITHHELD; HOWEVER, DUE TO THE PROGRAMMED HIGH-RATE TIME OUT FUNCTION, THERAPY WAS DELIVERED FOR DETECTED 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 22978308 ↗
• InjuryAug 29, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PATIENT EXPERIENCED SYNCOPE. A REMOTE TRANSMISSION INDICATED THAT ICD DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCKED FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) WHICH THE DEVICE DETECTED AND TREATED AS VENTRICULAR FIBRILLATION (VF). THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s); Syncope/Fainting

  MAUDE report 22923275 ↗
• InjuryAug 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED SYMPTOMATIC HEART BLOCK WITH ASYNCHRONOUS PACING WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE ICD WAS EXPLANTED AND REPLACED. ADDITIONALLY, IT WAS NOTED THAT A VENOGRAM WAS PERFORMED ON THE LEFT WHICH REVEALED AN OCCLUDED LEFT SUBCLAVIAN. THE RIGHT VENTRICULAR (RV) LEAD REMAINS IN USE BUT THE NEW SYSTEM HAD TO BE PLACED ON THE OTHER SIDE. DURING THE IMPLANT PROCEDURE, THE LEFT VENTRICULAR (LV) LEAD DISLODGED AND THE PHYSICIAN WAS NOT ABLE TO GET IT BACK INTO PLACE SO THE LEAD WAS ABANDONED. THE LEFT BUNDLE LEAD WAS PLACED BUT THEN DISLODGED UPON SPLITTING THE SHEATH AND WAS REPLACED WITH A RIGHT VENTRICULAR (RV) LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Heart Block

  MAUDE report 22820849 ↗
• InjuryAug 13, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE SHOCKS FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE EPISODE THAT WAS DETECTED AS VENTRICULAR FIBRILLATION (VF). THE DEVICE 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 22792843 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VENTRICULAR PACING FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INITIATED A RUN OF VENTRICULAR TACHYCA RDIA (VT) ON TELEMETRY. PACING PARAMETERS WERE REPROGRAMMED AND THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 22574117 ↗
• InjuryJul 14, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY EXPERIENCED APPROXIMATELY THREE EPISODES OF SYNCOPE, DURING WHICH THEY FELL TO THE GROUND. THE PATIENT STATED THAT EMERGENCY MEDICAL TECHNICIAN (EMT) PERSONNEL NOTED AN ABNORMAL RHYTHM AND TRANSPORTED THEM TO THE EMERGENCY ROOM (ER). THE PATIENT RECALLED AN ADDITIONAL EPISODE THREE MONTHS AND SIX MONTHS PRIOR. THE PATIENT EXPRESSED CONCERN THAT ¿SOMETHING IS NOT CONNECTING¿ IN THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PATIENT FURTHER REPORTED FEELING A SHOCK-LIKE SENSATION WHEN TOUCHING DOORKNOBS BUT WAS UNSURE IF THE ICD DELIVERED ANY THERAPY. THE PATIENT WAS UNABLE TO CONFIRM WHETHER THE THERAPY WAS DELIVERED APPROPRIATELY. 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); Syncope/Fainting; Tachycardia

  MAUDE report 22500412 ↗
• MalfunctionJul 3, 2025Battery Problem; Battery Problem

  IT WAS FURTHER REPORTED THAT THE ICD WAS EXPLANTED AND REPLACED WITH A GENERATOR REPLACEMENT DUE TO THE DEVICE AT END OF BATTERY LIFE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395990 ↗
• InjuryJun 21, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) DETECTED AS VENTRICULAR FIBRILLATION (VF) DUE TO A FEATURE THAT ALLOWS THE DEVICE TO OVERRIDE SVT DISCRIMINATION AND DELIVER THERAPY FOR A TACHYARRHYTHMIA THAT CONTINUES BEYOND A PROGRAMMED LENGTH OF TIME. THE PATIENT WAS HOSPITALIZED AND 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 22303818 ↗
• InjuryJun 10, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT POTENTIALLY RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCK THERAPY FOR AN EPISODE DETECTED IN THE FAST VENTRICULAR TACHYCARDIA (FVT) ZONE THAT WAS SUSPECTED TO BE ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. 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 22179530 ↗
• InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO INFECTION. IT WAS NOTED THAT THE SOURCE OF THE INFECTION WAS RECENT COLON SURGERY AND THE INFECTION WAS CAUSED BY GRAM-POSITIVE COCCI. THE PATIENT ALSO EXPERIENCED FEVER, SEPSIS, SEPTIC SHOCK, BACTEREMIA, AND VEGETATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Fever; Sepsis; Septic Shock; Unspecified Infection

  MAUDE report 22090865 ↗
• InjuryMay 23, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) 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 22079166 ↗
• InjuryMay 19, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS DETECTED AS FAST VENTRICULAR TACHYCARDIA (FVT). IN ADDITION, THERE WAS POSSIBLE T-WAVE OVERSENSING (TWOS) OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RV 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 22045113 ↗
• InjuryMay 16, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POSSIBLY DELIVERED AN INAPPROPRIATE SHOCK FOR SUPRA VENTRICULAR TACHYCARDIA (SVT). THE ICD DETECTED THE EPISODE AS VENTRICULAR FIBRILLATION (VF). THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPL ICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22040078 ↗
• MalfunctionApr 3, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) MISCLASSIFIED A VENTRICULAR TACHYCARDIA (VT) EPISODE AS SUPRA VENTRICULAR TACHYCARDIA (SVT). THE 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 21766799 ↗
• InjuryMar 18, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing 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 AN ARRHYTHMIA DETECTED IN THE VENTRICULAR TACHYCARDIA (VT) ZONE. THE DEVICE 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 21635021 ↗