Evera MRI XT DR SureScanRecalls & reported problems across all models

We found 8 models of Evera MRI XT DR SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 5,363 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2016 and Sep 30, 2026 — classified as 120 deaths, 3,749 injuries, 1,494 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (1,808 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 MRI XT DR SureScan 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-1712-2023 · 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-1711-2023 · 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 2 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-0585-2018 · Root cause: Process design · names 4 of these models · Recall details · FDA record ↗

Most reported Evera MRI XT DR SureScan problems

Evera MRI XT DR SureScan models

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

• Evera MRI™ XT DR SureScan® DDMB1D4

  Implantable cardioverter defibrillator (non-CRT)
  1 recall35 deaths1,426 reports
• Evera MRI™ XT DR SureScan® DDMB1D4

  Implantable cardioverter defibrillator (non-CRT)
  1 recall24 deaths1,241 reports
• Evera MRI™ XT DR SureScan® DDMB1D4

  Implantable cardioverter defibrillator (non-CRT)
  2 recalls24 deaths945 reports
• Evera MRI™ XT DR SureScan™ DDMB1D1

  Implantable cardioverter defibrillator (non-CRT)
  1 recall16 deaths827 reports
• Evera MRI™ XT DR SureScan™ DDMB1D1

  Pulse generator, permanent, implantable
  2 recalls9 deaths253 reports
• Evera MRI™ XT DR SureScan® DDMB1D1

  Implantable cardioverter defibrillator (non-CRT)
  1 recall6 deaths287 reports
• Evera MRI™ XT DR SureScan® DDMB1D4

  Implantable cardioverter defibrillator (non-CRT)
  1 recall3 deaths260 reports
• Evera MRI™ XT DR SureScan™ DDMB1D1

  Pulse generator, permanent, implantable
  1 recall3 deaths124 reports

Recent Evera MRI XT DR SureScan adverse event reports

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

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 50951356 ↗
• InjurySep 30, 2026Unable to Obtain Readings; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that electrograms (EGM) data associated with the Anti-Tachycardia Pacing (ATP) was recorded for review, but there was no EGM data associated with the shock therapy. The shock treatments fell into suspended EGM. Information received on the remote transmission was reviewed by qualified personnel. It was determined that the device was functioning within normal parameters as it had reached a set of predetermined conditions that stops collecting this data. However, the patient did received an inappropriate shock for Supra Ventricular Tachycardia (SVT) misdetected 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 50946804 ↗
• InjurySep 29, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the patient received possible inappropriate Anti-Tachycardia Pacing (ATP) and shocks for Supra Ventricular Tach ycardia (SVT) detected as Ventricular Fibrillation (VF). Additionally, the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) events. 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 50938082 ↗
• InjurySep 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 shocked for Atrial Fibrillation (AF) with Rapid Ventricular Response (RVR) 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)

  MAUDE report 50934262 ↗
• InjurySep 28, 2026Pacing Problem

  It was reported that the patient indicated that today several blood pressure reading were performed that showed heart rate was "45 or 46" and indicated that the device is set to 60.  The patient was referred to the physician.  The Implantable Cardioverter Defibrillator (ICD) remains in use.

  Patient problems: Bradycardia

  MAUDE report 50916593 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50916113 ↗
• 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 23, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50871078 ↗
• MalfunctionSep 23, 2026Pacing Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) exhibited atrial events falling in blanking period resulting in the device classified termination of AT/AF detected events with some unnecessary atrial pacing. 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 50870245 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Wound Dehiscence

  MAUDE report 50829272 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Medical device site infection; Wound Dehiscence

  MAUDE report 50826961 ↗
• InjurySep 18, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) device may have provided inappropriate therapy for detected Ventricular Fibrillation (VF) that was suspected Atrial Tachycardia/Atrial Fibrillation (AT/AF) with Fast Ventricular Response. 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 50820082 ↗
• 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 16, 2026Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50796442 ↗

Other Medtronic, Inc. products

• CapSureFix Novus MRI SureScan29 models · 87,337 reports
• Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
• Intellis AdaptiveStim3 models · 35,469 reports
• SYNCHROMED II11 models · 32,260 reports · 4 recalls
• CAPSUREFIX NOVUS17 models · 27,547 reports
• INTERSTIM30 models · 24,415 reports · 1 recall
• Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
• Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls