Evera XT VRRecalls & reported problems across all models

We found 6 models of Evera XT VR by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 867 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2015 and Sep 29, 2026 — classified as 29 deaths, 641 injuries, 197 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (212 reports).

4 FDA recall records name at least one of these models by its device identifier, 3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Evera XT VR recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 10, 2023Open, 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-1796-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. May 10, 2023Open, 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-1795-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Feb 3, 2021Open, 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 · names 4 of these models · Recall details · FDA record ↗

4. Dec 19, 2017Terminated

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

   Z-0587-2018 · Root cause: Process design · names 2 of these models · Recall details · FDA record ↗

Most reported Evera XT VR problems

Evera XT VR models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Evera™ XT VR DVBB1D4

  Implantable cardioverter defibrillator (non-CRT)
  2 recalls20 deaths489 reports
• Evera™ XT VR DVBB1D1

  Implantable cardioverter defibrillator (non-CRT)
  2 recalls9 deaths359 reports
• Evera™ XT VR DVBB1D1

  Implantable cardioverter defibrillator (non-CRT)
  1 recall18 reports
• Evera™ XT VR DVBB1D4

  Implantable cardioverter defibrillator (non-CRT)
  1 recall1 report
• Evera™ XT VR DVBB1D4

  Implantable cardioverter defibrillator (non-CRT)
  1 recall0 reports
• Evera™ XT VR DVBB1D1

  Implantable cardioverter defibrillator (non-CRT)
  1 recall0 reports

Recent Evera XT VR adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Failure to Deliver Shock/Stimulation; Device Sensing Problem

  Patient problems: Syncope/Fainting; Ventricular Fibrillation

  MAUDE report 50931672 ↗
• InjurySep 17, 2026Electrical /Electronic Property Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) possibly delivered inappropriate shocks and Anti-Tachycardia Pacing (ATP) for Atrial Fibrillation (AF) with Rapid Ventricular Response (RVR). The ICD detected the episodes as Fast Ventricular Tachycardia (FVT). The ICD also alerted due to the charge circuit being inactive. 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 50803436 ↗
• InjurySep 11, 2026Delayed Charge Time

  It was reported that the Implantable Cardioverter Defibrillator (ICD) exhibited long charge times and a charge circuit timeout, resulting in a delay of therapy for the patient's Ventricular Fibrillation (VF) episode. The patient remained in Ventricular Fibrillation (VF). The device was explanted and replaced.

  Patient problems: Ventricular Fibrillation

  MAUDE report 50732678 ↗
• InjurySep 9, 2026Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50697992 ↗
• MalfunctionJul 8, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25750634 ↗
• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO SENSING INTEGRITY COUNTER (SIC) AND PACING IMPEDANCE VARIATION. OVERSENSING OF NOISE WAS OBSERVED. TACHYCARDIA THERAPY WAS PROGRAMMED OFF AND THE RV LEAD REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE PATIENT WAS REFERRED TO A DIFFERENT FACILITY FOR RV LEAD EXTRACTION/IMPLANT. THE PHYSICIAN DECLINED TO PERFORM THE PROCEDURE DUE TO INFECTION ON THE 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: Unspecified Infection

  MAUDE report 25642144 ↗
• InjuryJun 9, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE SHOCKS FOR A DETECTED VENTRICULAR FIBRILLATION (VF) THAT WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT). IN ADDITION, IT WAS NOTED THAT THE ICD DETECTED RUNS OF VENTRICULAR TACHYCARDIA (VT) THAT WAS SUSPECTED TO BE ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25447007 ↗
• MalfunctionJun 5, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT NOTED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IS "NOT FIRING CORRECTLY" AND IS EXPERIENCING A "BURNING" SENSATION AT DEVICE SITE. 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 25409425 ↗
• InjuryMay 29, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT HAD A "MAJOR" STROKE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Stroke/CVA

  MAUDE report 25336687 ↗
• MalfunctionMay 22, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) MISDETECTED AS VENTRICULAR T ACHYCARDIA (VT). THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Shock from Patient Lead(s)

  MAUDE report 25257375 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Medical device site infection; Unspecified Infection

  MAUDE report 25247272 ↗
• InjuryMay 19, 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 SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR POSSIBLE SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT THE DEVICE CLASSIFIED 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 25218443 ↗
• MalfunctionMay 18, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) FOR DETECTED VENTRICULAR TACHYCARDIA (VT) EPISODES THAT WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT). THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25207561 ↗
• InjuryMay 5, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEY WERE HOSPITALIZED FOR A SMALL STROKE FOR TWO DAYS. THE PATIENT NOTED THAT AT NIGHT, THEIR HEART MONITOR WOULD "ALARM" THAT THEIR HEART RATE WAS LOW AND IN THE THIRTIES. THE PATIENT NOTED THAT TWO WEEKS PRIOR TO THEIR HOSPITAL STAY, THEY NOTICED THAT THEIR HEART RATE WAS LOW AS WELL.  ADDITIONALLY, THE PATIENT MENTIONED THAT APPROXIMATELY TWO MONTHS PRIOR TO THE CALL, THEY HAD BRADYCARDIA AGAIN AFTER ABOUT TEN YEARS WITHOUT IT. THE PATIENT WAS CONCERNED WITH THEIR HEART RATE DROPPING LOW AT NIGHT AND WHEN THEY REST, STATING "IT COULD BE PROBLEMATIC". THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Transient Ischemic Attack

  MAUDE report 25086435 ↗
• DeathMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY EXPERIENCED A SUSPECTED INFECTION AND RECEIVED EXTENSIVE ANTIBIOTIC TREATMENT. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25084528 ↗

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