Visia AF MRI S VR SureScanRecalls & reported problems across all models

We found 7 models of Visia AF MRI S VR SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 116 adverse event reports in the FDA's MAUDE database, received between Jun 5, 2017 and Jul 29, 2026 — classified as 2 deaths, 90 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (39 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

Visia AF MRI S 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, 2023Class IOpen, 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-1808-2023 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

2. May 10, 2023Class IOpen, 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-1807-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. 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 · names 2 of these models · Recall details · FDA record ↗

4. 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-0588-2018 · Root cause: Process design · names 2 of these models · Recall details · FDA record ↗

Most reported Visia AF MRI S VR SureScan problems

Visia AF MRI S VR SureScan models

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

• Visia AF MRI™ S VR SureScan™ DVFC3D4

  Pulse generator, permanent, implantable
  1 recall1 death70 reports
• Visia AF MRI™ S VR SureScan™ DVFC3D4

  Pulse generator, permanent, implantable
  2 recalls8 reports
• Visia AF MRI™ S VR SureScan™ DVFC3D1

  Implantable cardioverter defibrillator (non-CRT)
  2 recalls3 reports
• Visia AF MRI™ S VR SureScan™ DVFC3D4

  Implantable cardioverter defibrillator (non-CRT)
  1 recall1 death23 reports
• Visia AF MRI™ S VR SureScan™ DVFC3D1

  Pulse generator, permanent, implantable
  1 recall6 reports
• Visia AF MRI™ S VR SureScan™ DVFC3D1

  Pulse generator, permanent, implantable
  3 reports
• Visia AF MRI™ S VR SureScan™ DVFC3D4

  Implantable cardioverter defibrillator (non-CRT)
  3 reports

Recent Visia AF MRI S VR SureScan adverse event reports

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

• InjuryJul 29, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the patient received inappropriate Anti-Tachycardia Pacing therapy and a shocks for an episode detected in the Ventricular Tachycardia (VT) zone that was suspected to be Supra Ventricular Tachycardia (SVT). In addition, the Right Ventricular(RV) lead exhibited T-Wave Oversensing (TWOS) post ventricular pace. 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 50070984 ↗
• InjuryMay 7, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEY EXPERIENCED BEING UNCONSCIOUS AND ENDED UP IN THE HOSPITAL. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 25113225 ↗
• MalfunctionApr 29, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT DURING USE OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THE DEVICE BATTERY WAS NOTED AS CRITICALLY LOW AFTER MULTIPLE SHOCKS ADMINISTERED BY THE ICD. THE ICD WAS SUBSEQUENTLY EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25027730 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN UNSPECIFIED INFECTION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS SUBSEQUENTLY EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 24240070 ↗
• InjuryJan 26, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY FELT "A BIG SHOCK". THE PATIENT STATED THEY WERE MOVING A DOORWAY GATE IN THEIR HOUSE WHEN THEY FELT A LARGE SHOCK AND SAID THEY "SAW BLUE". THE PATIENT DID NOT KNOW IF THEY HIT SOMETHING WHEN MOVING THE GATE THAT SHOCKED THEM OR IF THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SHOCKED THEM. THE ICD REMAINS IN USE. THE MONITOR IS EXPECTED TO BE REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY FROM THE ICD FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT WAS DETECTED AS VENTRICULAR TACHYCARDIA (VT). THE PATIENT UNDERWENT AN ABLATION PROCEDURE AND THE ICD WAS EXPLANTED DURING AN UPGRADE PROCEDURE TO A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D).

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24184776 ↗
• InjuryJan 22, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED ANTI-TACHYCARDIA PACING (ATP) AND SHOCKS FOR POSSIBLE SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS DETECTED AS VENTRICULAR TACHYCARDIA (VT). IT WAS NOTED THAT THERAPY WAS INITIALLY WITHHELD FOR THE TREATED VT EPISODES DUE TO THE DEVICE DISCRIMINATOR. THE DEVICE 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 24145372 ↗
• MalfunctionNov 14, 2025Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED POSSIBLE ANTI-TACHYCARDIA PACING (ATP) THERAPY FOR A DETECTED FAST VENTRICULAR TACHYCARDIA (FVT) EPISODE THAT WAS A SUSPECTED SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODE. 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 23555384 ↗
• InjurySep 2, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED VIA INTERNAL REVIEW OF HISTORICAL DEVICE DATA TRANSMITTED FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THAT INAPPROPRIATE HIGH-VOLTAGE THERAPY WAS DELIVERED FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) DETECTED IN THE VENTRICULAR TACHYCARDIA (VT) 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 22946177 ↗
• InjuryJul 1, 2025Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT DURING USE OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THE PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY. IT WAS NOTED THAT NOISE AND OVERSENSING WERE OBSERVED ON THE SHOCK EPISODES THAT CORRELATED WITH THE TIME THAT THE PATIENT WAS UNDERGOING A LEFT LOWER EXTREMITY AMPUTATION. THE EPISODES WERE NOT CONSISTENT WITH A LEAD ISSUE. ADDITIONALLY, THE ICD INAPPROPRIATELY DETECTED A VENTRICULAR FIBRILLATION (VF) EPISODE. NO ACTION WAS TAKEN. 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 22377393 ↗
• InjuryApr 3, 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) POSSIBLY DELIVERED INAPPROPRIATE SHOCKS AND ANTI-TACHYCARDIA PACING (ATP) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT). 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 21769805 ↗
• InjuryFeb 5, 2025Defibrillation/Stimulation Problem; Device Sensing Problem; Defibrillation/Stimulation Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PALPITATIONS. IT WAS FURTHER REPORTED THAT THERAPY WAS INAPPROPRIATELY WITHHELD FOR AN EPISODE OF VENTRICULAR FIBRILLATION (VF) WHICH RESULTED IN A DELAY OF THERAPY. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED THE VF EPISODE AS SUPRA VENTRICULAR TACHYCARDIA (SVT). THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia; Ventricular Fibrillation

  MAUDE report 21312559 ↗
• InjuryJan 23, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PREMATURE BATTERY DEPLETION. THE ICD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21223637 ↗
• MalfunctionJan 15, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED ECTOPY WHICH WAS MISCLASSIFIED AS ATRIAL FIBRILLATION (AF). 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 21159569 ↗
• MalfunctionJan 6, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PRIOR TO IMPLANT, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS INTERROGATED AND THE BATTERY STATUS INDICATOR BAR WAS GREY. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21080012 ↗
• InjuryNov 18, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) FOR SHORTNESS OF BREATH, DIZZINESS, AND COMPLAINED OF A LOW HEART RATE BELOW 40 BEATS PER MINUTE (BPM). REVIEW OF THE REMOTE TRANSMISSION SHOWED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED ANTI-TACHYCARDIA PACING (ATP) AND SHOCK FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS 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: Bradycardia; Dizziness; Dyspnea; Shock from Patient Lead(s)

  MAUDE report 20708707 ↗

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