Visia AF MRI VR SureScanRecalls & reported problems across all models

We found 7 models of Visia AF MRI VR SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 2,123 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2016 and Sep 30, 2026 — classified as 38 deaths, 1,662 injuries, 423 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (704 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 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-1804-2023 · 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-1803-2023 · 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 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-0588-2018 · Root cause: Process design · names 3 of these models · Recall details · FDA record ↗

Most reported Visia AF MRI VR SureScan problems

Visia AF MRI VR SureScan models

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

• Visia AF MRI™ VR SureScan™ DVFB1D4

  Pulse generator, permanent, implantable
  1 recall10 deaths645 reports
• Visia AF MRI™ VR SureScan™ DVFB1D4

  Pulse generator, permanent, implantable
  1 recall12 deaths554 reports
• Visia AF MRI™ VR SureScan™ DVFB1D4

  Pulse generator, permanent, implantable
  2 recalls10 deaths453 reports
• Visia AF MRI™ VR SureScan™ DVFB1D4

  Pulse generator, permanent, implantable
  1 recall2 deaths173 reports
• Visia AF MRI™ VR SureScan™ DVFB1D1

  Pulse generator, permanent, implantable
  2 recalls1 death106 reports
• Visia AF MRI™ VR SureScan™ DVFB1D1

  Implantable cardioverter defibrillator (non-CRT)
  1 recall1 death135 reports
• Visia AF MRI™ VR SureScan™ DVFB1D1

  Implantable cardioverter defibrillator (non-CRT)
  2 deaths57 reports

Recent Visia AF MRI VR 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, 2026Failure to Deliver Shock/Stimulation; Device Sensing Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) possibly inappropriately withheld high-voltage therapy for Ventricular Fibrillation (VF) to the patient by wavelet discriminator noted on some Supra Ventricular Tachycardia (SVT) episodes. The ICD remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Ventricular Fibrillation

  MAUDE report 50949546 ↗
• InjurySep 28, 2026Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient received several inappropriate shocks from the Implantable Cardioverter Defibrillator (ICD) during a spinal cord stimulator surgery prior to magnet application. It was also observed that a Lead Integrity Alert (LIA) was triggered during the surgery. 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 50918884 ↗
• InjurySep 25, 2026Premature Discharge of Battery

  It was reported that the Implantable Cardioverter Defibrillator (ICD) unexpectedly reached Recommended Replacement Time (RRT). The patient reportedly experienced "odd symptoms" which the physician noted may or may not be related to the device. The device was explanted and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Insufficient Information

  MAUDE report 50898433 ↗
• InjurySep 18, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50829435 ↗
• InjurySep 17, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50809156 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) patient experienced an unspecified infection with discomfort, fever, and pain. The patient was hospitalized and the device system was explanted. No further patient complications have been reported as a result of this event.

  Patient problems: Discomfort; Fever; Pain; Unspecified Infection

  MAUDE report 50805302 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Bacterial Infection; Medical device site infection

  MAUDE report 50739423 ↗
• InjurySep 9, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50699665 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) system was explanted due to an infection in the blood. The patient experienced a fever. No further patient complications have been reported as a result of this event.

  Patient problems: Fever; Sepsis; Unspecified Infection

  MAUDE report 50696080 ↗
• InjurySep 5, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50625499 ↗
• InjurySep 3, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50596617 ↗
• InjurySep 2, 2026Failure to Deliver Shock/Stimulation; Device Sensing Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) device may have inappropriately withheld therapy for detected Supra Ventricular Tachycardia (SVT) that was suspected Ventricular Tachycardia (VT). The device remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Tachycardia

  MAUDE report 50566243 ↗
• InjurySep 1, 2026Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  It was reported that during use of the Implantable Cardioverter Defibrillator (ICD) it was discovered that oversensing on the ventri cular lead in non-physiologic intervals/Electromagnetic Interference (EMI) occurred that resulted in inappropriate shock. The allied healthcare professional reported that patient received the inappropriate shock while having cauterization on the arm. The ICD rema ins in use. No further patient complications have been reported as a result of this event.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50547379 ↗
• InjuryAug 19, 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 episodes 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 50333167 ↗
• MalfunctionAug 12, 2026Pacing Problem; Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50226935 ↗

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