Visia AF MRI™ S VR SureScan™ DVFC3D1 (UDI 00763000060107)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000060107), received between Apr 19, 2022 and Jan 22, 2026 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Sensing Problem” (3 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-1807-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• InjuryMar 22, 2024Pacing 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) INAPPROPRIATELY DELIVERED A SHOCK AND ANTI-TACHYCARDIA PACING FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) WHEN THE DEVICE MISCLASSIFIED THE EPISODE AS VENTRICULAR FIBRILLATION (VF). IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED VARIABLE IMPEDANCE MEASUREMENTS. THE 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 18960436 ↗
• InjuryFeb 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DAY AFTER IMPLANT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THE PATIENT DEVELOPED A HEMATOMA. THE POCKET WAS EVACUATED, AND THE ANTIBACTERIAL ABSORBABLE ENVELOPE WAS REMOVED AND REPLACED. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hematoma

  MAUDE report 16385603 ↗
• MalfunctionApr 19, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A GENERATOR CHANGE, THE SETSCREW FOR THE RIGHT VENTRICULAR (RV) COIL PORT WOULD NOT ENGAGE. THE PHYSICIAN DESCRIBED THE SETSCREW AS BEING STRIPPED, AND AFTER MULTIPLE ATTEMPTS ASKED FOR A NEW DEVICE. THE DEVICE WAS NEVER IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14141488 ↗