Evera MRI XT VR SureScanRecalls & reported problems across all models

We found 2 models of Evera MRI XT VR SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 274 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2016 and Jun 19, 2026 — classified as 7 deaths, 213 injuries, 54 malfunctions.

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

3 FDA recall records name at least one of these models by its device identifier, 2 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 VR 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-1809-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. 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 · Recall details · FDA record ↗

3. 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 · Recall details · FDA record ↗

Most reported Evera MRI XT VR SureScan problems

Evera MRI XT VR SureScan models

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

• Evera MRI™ XT VR SureScan® DVMB1D4

  Implantable cardioverter defibrillator (non-CRT)
  2 recalls7 deaths272 reports
• Evera MRI™ XT VR SureScan® DVMB1D4

  Pulse generator, permanent, implantable
  1 recall2 reports

Recent Evera MRI XT VR SureScan adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO A METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS (MSSA) BACTEREMIA INFECTION. THE PATIENT ALSO EXPERIENCED ENDOCARDITIS. IN ADDITION, LEAD VEGETATION WAS CONFIRMED VIA T RANSESOPHAGEAL ECHOCARDIOGRAM (TEE). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Bacterial Infection; Endocarditis; Unspecified Infection

  MAUDE report 24753512 ↗
• 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 ↗

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