Visia AF MRI™ VR SureScan™ DVFB1D4 (UDI 00763000059507)Recalls & reported problems

Summary

The FDA's MAUDE database contains 554 adverse event reports that list this exact device (DI 00763000059507), received between Feb 8, 2018 and Sep 17, 2026 — classified as 12 deaths, 446 injuries, 96 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (208 reports).

1 FDA recall record name this device's identifier, 1 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

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-1804-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 554 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50809156 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Bacterial Infection; Medical device site infection

  MAUDE report 50739423 ↗
• 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 ↗
• MalfunctionJul 30, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50089039 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the  Implantable Cardioverter Defibrillator (ICD) patient experienced a infection with erosion. The device system was explanted. No further patient complications have been reported as a result of this event.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 50037350 ↗
• MalfunctionJul 27, 2026Electromagnetic Interference; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50037311 ↗
• InjuryJul 13, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT PATIENT GOT INAPPROPRIATELY SHOCKED DUE OVERSENSING DURING A SURGICAL PROCEDURE. IT WAS REPORTED THAT A MAGNET WAS USED BUT WASN'T PLACED APPROPRIATELY AND PATIENT THEREFORE GOT SHOCKED. 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 25807785 ↗
• InjuryJun 30, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE MAY HAVE DELIVERED INAPPROPRIATE SHOCKS AND ANTI-TACHYCARDIA PACING (ATP) FOR DETECTED VENTRICULAR FIBRILLATION (VF) THAT WAS SUSPECTED SUPRA VENTRICULAR TACHYCARDIA (SVT). 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 25666649 ↗
• MalfunctionMay 29, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED ECTOPIC BEATS AS ATRIAL FIBRILLATION (AF). ADDITIONALLY, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS) AND A DECREASE IN R-WAVE AMPLITUDE. THE ICD AND RV LEAD 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 25334725 ↗
• InjuryMay 26, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY AND ANTI-TACHYCARDIA PACING (ATP) FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AF) WITH FAST VENTRICULAR RESPONSE THAT WAS DETECTED AS VENTRICULAR FIBRILLATION (VF). THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR TWO OR MORE HIGH RATE NON SUSTAINED EPISODES, SENSING INTEGRITY COUNTER (SIC) AND A WARNING TRIGGERED FOR LOW RV PACING IMPEDANCE. THE RV LEAD 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 25291175 ↗
• InjuryMay 20, 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 AN EPISODE DETECTED AS VENTRICULAR FIBRILLATION (VF) THAT WAS POSSIBLE SUPRA VENTRICULAR TACHYCARDIA (SVT). 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 25232662 ↗
• InjuryMay 18, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED 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: Shock from Patient Lead(s)

  MAUDE report 25210592 ↗
• InjuryMay 15, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) MAY HAVE DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FOR AN SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODES DETECTED 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 25191702 ↗
• DeathMay 6, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FROM THE SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR POSSIBLE SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT THE DEVICE CLASSIFIED AS VENTRICULAR TACHYCARDIA (VT). THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Arrest; Shock from Patient Lead(s)

  MAUDE report 25091763 ↗
• InjuryMay 4, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) THERAPIES AND SHOCKED FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE WHICH THE DEVICE DETECTED AND TREATED AS VENTRICULAR FIBRILLATION (VF). THE PATIENT STATED THAT THEY WERE SYMPTOMATIC OF THE ARRHYTHMIA AND FELT MUCH BETTER AFTER THE SHOCK. 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 25075928 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A DEVICE POCKET INFECTION, EROSION, PURULENT DISCHARGE, REDNESS, AND SWELLING. THE P ATIENT WAS ADMINISTERED ANTIBIOTIC MEDICATION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Erythema; Medical device site infection; Purulent Discharge; Swelling/ Edema

  MAUDE report 25033761 ↗
• InjuryApr 14, 2026Signal Artifact/Noise; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED A SHOCK FOR AN EPISODE DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE THAT WAS SUSPECTED TO BE NOISE. IT WAS NOTED THAT THE PATIENT WAS BELIEVED TO HAVE BEEN IN BED AND ON A VENTILATOR AT THE TIME OF THE EPISODE. 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 24876776 ↗
• InjuryApr 10, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCKS FOR VENTRICULAR TACHYCARDIA (VT) THAT WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT). 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 24840878 ↗
• MalfunctionApr 8, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED EPISODES THAT WERE INTERPRETED AS POSSIBLE INAPPROPRIATE DETECTION, IN WHICH A SUPRAVENTRICULAR TACHYCARDIA (SVT) WAS DETECTED AS NON SUSTAINED VENTRICULAR TACHYCARDIA (VT), RAISING CONCERN FOR A POTENTIAL RISK OF INAPPROPRIATE THERAPY. OF NOTE, NO THERAPIES WERE DELIVERED. 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 24821116 ↗
• InjuryMar 30, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) THERAPY AND SHOCKS FOR EPISODES OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE DETECTED AS VENTRICULAR TACHYCARDIA (VT). 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 24736585 ↗
• InjuryMar 26, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS FOR EPISODES DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE 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 24698982 ↗
• MalfunctionMar 24, 2026Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR HIGH-RATE, NON-SUSTAINED EPISODES AND SHORT VENTRICULAR INTERVALS. THE LEAD REMAINS IN USE. ABOUT THREE YEARS LATER, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD ANOTHER LIA TRIGGER FOR HIGH-RATE, NON-SUSTAINED EPISODES AND SHORT VENTRICULAR INTERVALS; HOWEVER, ALL THE EPISODES FROM THIS DAY WERE RECORDED IN A SHORT PERIOD OF TIME ON THE SAME DAY. ANY NOISE WAS UNABLE TO BE REPRODUCED WITH IN-CLINIC TESTING. RECORDED EPISODES SHOW SIMULTANEOUS COHERENT NEARLY IDENTICAL MORPHOLOGY NOISE ON BOTH CHANNELS, REASONABLY EXPLAINING SOME TYPE OF ELECTROMAGNETIC INTERFERENCE, LIKELY CAUTERY. 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 24675316 ↗
• InjuryMar 23, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND INAPPROPRIATE HIGH VOLTAGE THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED 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 24662171 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO INFECTION. VEGETATION ON THE RIGHT VENTRICULAR (RV) LEAD COIL AND TRICUSPID VALVE WAS OBSERVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection

  MAUDE report 24637221 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A BACTEREMIA INFECTION. THE ORGANISM WAS IDENTIFIED AS STAPHYLOCOCCUS AUREUS. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Bacterial Infection

  MAUDE report 24620341 ↗