Evera XT DRRecalls & reported problems across all models

We found 10 models of Evera XT DR by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 1,900 adverse event reports in the FDA's MAUDE database, received between Jun 10, 2014 and Sep 28, 2026 — classified as 58 deaths, 1,321 injuries, 521 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (530 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 DR 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-1705-2023 · Root cause: Under Investigation by firm · names 2 of these models · 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-1704-2023 · Root cause: Under Investigation by firm · names 2 of these models · 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 4 of these models · Recall details · FDA record ↗

Most reported Evera XT DR problems

Evera XT DR models

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

• Evera™ XT DR DDBB1D1

  Implantable cardioverter defibrillator (non-CRT)
  2 recalls22 deaths740 reports
• Evera™ XT DR DDBB1D4

  Implantable cardioverter defibrillator (non-CRT)
  2 recalls21 deaths640 reports
• Evera™ XT DR DDBB1D1

  Implantable cardioverter defibrillator (non-CRT)
  2 recalls7 deaths268 reports
• Evera™ XT DR DDBB1D1

  Implantable cardioverter defibrillator (non-CRT)
  1 recall2 deaths97 reports
• Evera™ XT DR DDBB1D1

  Implantable cardioverter defibrillator (non-CRT)
  1 recall5 deaths72 reports
• Evera™ XT DR DDBB1D4

  Implantable cardioverter defibrillator (non-CRT)
  1 recall1 death28 reports
• Evera™ XT DR DDBB1D4

  Pulse generator, permanent, implantable
  1 recall20 reports
• Evera™ XT DR DDBB1D1

  Pulse generator, permanent, implantable
  1 recall11 reports
• Evera™ XT DR DDBB1D4

  Implantable cardioverter defibrillator (non-CRT)
  1 recall7 reports
• Evera™ XT DR DDBB1D4

  Implantable cardioverter defibrillator (non-CRT)
  17 reports

Recent Evera XT DR adverse event reports

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

• MalfunctionSep 28, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915136 ↗
• MalfunctionSep 16, 2026Electromagnetic Interference

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50796577 ↗
• MalfunctionSep 16, 2026Battery Problem

  It was reported that there was an inquiry made on advisory for potential shortened Recommended Replacement Time (RRT) to End of Service (EOS). 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 50793081 ↗
• InjurySep 11, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50740763 ↗
• InjurySep 10, 2026Defibrillation/Stimulation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50718260 ↗
• MalfunctionAug 10, 2026Electromagnetic Interference

  It was reported that the patient stated that they had heard some beeping from their Implantable Cardioverter Defibrillator (ICD) believed to be Electromagnetic Interference. The patient had been working near some power tools and had noted that they may have had their phone in their breast pocket of their shirt. The patient did not note any symptoms. The ICD remains in use. The patient is a participant in a clinical study. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50198173 ↗
• InjuryAug 6, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) detected an episode of Ventricular Fibrillation (VF) that may have been Atrial arrhythmia with Rapid Ventricular Response (RVR) versus true VF and was treated with Antitachycardia Pacing (ATP) and shocks. 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 50161462 ↗
• MalfunctionAug 6, 2026Electromagnetic Interference; Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50158269 ↗
• InjuryJul 29, 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 shock for Supra Ventricular Tachycardia (SVT) that was detected in the Ventricular Tachycardia (VT) zone. Eleven days later, the ICD del ivered inappropriate ATP and shock for sinus tachycardia detected in the Ventricular Fibrillation (VF) zone. 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 50074874 ↗
• InjuryJul 27, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that one day post implant of the Implantable Cardioverter Defibrillator (ICD) the patient had a stroke which damaged the patient's fontal lobe. The device was explanted and replaced approximately eleven years later. The Right Atrial (RA) lead and Right Ventricular (RV) lead remain in use. No further patient complications have been reported as a result of this event.

  Patient problems: Stroke/CVA

  MAUDE report 50012459 ↗
• InjuryJun 30, 2026Pacing 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 SUPRA VENTRICULAR TACHYCARDIA (SVT). 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 25673734 ↗
• MalfunctionJun 22, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POSSIBLY DETECTED AN EPISODE OF ANOTHER 1:1 SUPRA VENTRICULAR TACHYCARDIA (SVT) AS NON-SUSTAINED VENTRICULAR TACHYCARDIA. 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 25580882 ↗
• InjuryJun 9, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POTENTIAL INAPPROPRIATE THERAPY FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE (RVR) THAT THE DEVICE DETECTED AS VENTRICULAR FIBRILLATION (VF). IN ADDITION, THERE WAS ATRIAL UNDERSENSING OBSERVED ON STORED EPISODES. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT ATRIAL (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 25446150 ↗
• InjuryMay 27, 2026Pacing 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 TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE (RVR). THE ICD DETECTED THE EPISODE 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 25311085 ↗
• InjuryMay 21, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POSSIBLY DELIVERED INAPPROPRIATE SHOCKS FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE (RVR). THE ICD DETECTED THE ARRHYTHMIA AS VENTRICULAR FIBRILLATION (VF). THE ICD WAS 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 25249610 ↗

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