Visia AF MRI™ S VR SureScan™ DVFC3D4 (UDI 00643169566446)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169566446), received between Jul 7, 2017 and Oct 23, 2023 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (4 reports).

2 FDA recall records 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. 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 · Recall details · FDA record ↗

2. 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2023Premature Discharge of Battery; Premature Discharge of Battery

  A FOLLOW UP WITH THE PATIENT'S HEALTHCARE PROVIDER YIELDED THAT THE DEVICE WAS REMOVED DUE TO SHORTENED RECOMMENDED REPLACEMENT TIME (RRT) TO END OF SERVICE (EOS) PER ADVISORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17986232 ↗
• InjuryJul 26, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED ABNORMAL BATTERY DEPLETION. 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 15102295 ↗
• InjuryJan 28, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) BATTERY HAD BEEN SIGNIFICANTLY DECREASING SINCE HITTING RECOMMENDED REPLACEMENT TIME (RRT) AND REACHED END OF SERVICE (EOS) IN LESS THAN ONE MONTH. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13385740 ↗
• InjuryMar 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS REMOVED DUE TO BACTEREMIA/INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 11581429 ↗
• InjurySep 17, 2019Premature Discharge of Battery; Premature Discharge of Battery

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9078030 ↗
• MalfunctionOct 11, 2018Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT AN INTERROGATION REPORT FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INDICATED THAT THERE WERE POSSIBLE INAPPROPRIATE PACING SPIKES. THE ICD WAS REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7957314 ↗
• InjuryOct 6, 2017Inappropriate/Inadequate Shock/Stimulation; Invalid Sensing; Inappropriate/Inadequate Shock/Stimulation; Invalid Sensing

  IT WAS REPORTED THAT THE PATIENT WAS INAPPROPRIATELY SHOCKED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WHILE IN ATRIAL FIB RILLATION (AF) DUE TO THE RIGHT VENTRICULAR (RV) LEAD DISLODGING AFTER THE PATIENT HAD TWIDDLED THE LEAD INTO THE RIGHT ATRIUM. A LEAD REVISION WAS ATTEMPTED; HOWEVER, THE HELIX WOULD NOT EXTEND DUE TO TISSUE ON THE TIP OF THE LEAD. THE LEAD WAS EXPLANTED AND REPLACED. 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 6923569 ↗
• MalfunctionJul 7, 2017Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)¿S IMPLANTED AND USED AS A SIZED FOR THE POCKET BEFORE IT WAS INTERROGATED. WHEN THE ICD WAS INTERROGATED IT EXHIBITED A GRAY BAR, INDICATING LOW TELEMETRY BATTERY VOLTAGE. THE DEVICE WAS NOT USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6692377 ↗