Visia AF MRI™ S VR SureScan™ DVFC3D4 (UDI 00763000060060)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00763000060060), received between Oct 29, 2021 and May 7, 2026 — classified as 1 death, 16 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (5 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-1808-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJun 26, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED BY THE PATIENT'S DAUGHTER THAT THEY DID NOT SET THE DEVICE BACK AFTER A MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED TWO WEEKS AGO. THE PATIENT EXPERIENCED HEART RATES OF 40 BEATS PER MINUTE (BPM) WHICH WAS BELOW THE THRESHOLD OF 60 BPM. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 19616625 ↗
• InjuryMar 21, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE YEAR POST-IMPLANT, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS REMOVED AND REPLACED WITH A BIVENTRICULAR DEFIBRILLATOR SYSTEM AFTER THE PATIENT DEVELOPED LEFT BUNDLE BRANCH BLOCK FROM FREQUENT VENTRICULAR PACING. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 18950967 ↗
• MalfunctionMar 18, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT AND SPOUSE STATED THAT THEY WERE HEARING SOUNDS FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ALL DAY YESTERDAY AND ALL DAY TODAY.  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 18922050 ↗
• InjuryJan 5, 2024Failure to Deliver Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THERE WAS POSSIBLE INAPPROPRIATE THERAPY DELIVERED, AS THE VENTRICULAR FIBRILLATION (VF) ARRHYTHMIA APPEARED TO HAVE TERMINATED BEFORE THE SECOND SHOCK WAS DELIVERED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD POTENTIALLY WITHHELD THERAPY INAPPROPRIATELY FOR A SUPRA VENTRICULAR TACHYCARDIA (SVT) DURING A SEPARATE EPISODE. THE RIGHT VENTRICULAR (RV) LEAD APPEARED TO BE UNDERSENSING DURING MONITORED AND TREATED EPISODES, WHICH RESULTED IN A POSSIBLE DELAY TO DETECTION/THERAPIES. A DECREASE IN R-WAVE AMPLITUDE WAS NOTED ON THE LEAD TRENDS. THE DEVICE AND 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 18454585 ↗
• InjuryNov 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALMOST TWO MONTHS POST IMPLANT, THE PATIENT EXPERIENCED AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POCKET INFECTION WITH PURULENT DISCHARGE AND REDNESS. THE ICD SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Purulent Discharge; Unspecified Infection

  MAUDE report 18210429 ↗
• InjuryOct 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS ERODING THE POCKET, WHICH WAS RED AND SWELLING. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Swelling/ Edema

  MAUDE report 17876376 ↗
• MalfunctionJan 5, 2023Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE REMOTE MONITOR HAD NO TELEMETRY WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL AND THE PATIENT WAS REFERRED TO CLINIC. THE ICD AND REMOTE MONITOR 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 16109488 ↗
• DeathNov 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Drug Resistant Bacterial Infection; Unspecified Infection

  MAUDE report 15826101 ↗
• InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS HAD CHRONIC BACTEREMIA SINCE THE IMPLANT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. THE SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 15789651 ↗
• InjuryOct 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 15528220 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A NECK SURGERY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POCKET DEVELOPED SIGNS OF INFECTION AND THE ICD SYSTEM WAS EXPLANTED DUE TO THE INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 14850799 ↗
• InjuryJun 9, 2022Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POSSIBLY DELIVERED THERAPY FOR AN ATRIAL ARRHYTHMIA. IT WAS NOTED THAT INITIALLY THE THERAPIES WERE WITHHELD FOR WAVELET BUT THEN WERE DELIVERED DUE TO HIGH RATE TIMEOUT. 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 14645416 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD'S R-WAVE AMPLITUDE HAD DECLINED SINCE IMPLANT. IT WAS FURTHER REPORTED THAT THE PATIENT WAS BROUGHT IN-CLINIC FOR A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) PROCEDURE WHICH SHOWED A LARGE VEGETATION ON THE RV LEAD. THE BLOOD CULTURES WERE POSITIVE HOWEVER THE ORGANISM IS UNKNOWN AT THIS TIME. IT WAS FURTHER NOTED THAT THE PATIENT HAS A HISTORY OF IV DRUG USE. THE PHYSICIAN MADE THE DECISION TO INTERVENE SURGICALLY BUT NOT TO EXTRACT THE LEAD OR THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AT THIS TIME. THE PATIENT IS BEING TREATED WITH ANTIBIOTICS AND IS BEING MONITORED. THE LEAD AND THE ICD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 14087027 ↗
• InjuryMar 31, 2022Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT WAS RECEIVING INAPPROPRIATE SHOCKS FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WHILE IN NORMAL SINUS RHYTHM. 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 13966709 ↗
• MalfunctionMar 8, 2022Electrical /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 13694057 ↗
• InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 13258822 ↗
• InjuryDec 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SEPSIS AND THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED AS A RESULT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Sepsis

  MAUDE report 13113759 ↗
• MalfunctionOct 29, 2021Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS INTERROGATED PRIOR TO IMPLANTED AND IT WAS NOTED THAT SEVERAL MOTHS PRIOR THE DEVICE HAD DETECTIONS/THERAPIES HAD BEEN TURNED ON AND THEN TURNED BACK OFF. THE DEVICE WILL NOT BE USED. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12722524 ↗