Visia AF MRI™ S VR SureScan™ DVFC3D4 (UDI 00643169988651)Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 00643169988651), received between Oct 5, 2018 and Jul 29, 2026 — classified as 1 death, 57 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (25 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 25 most recent of 70 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the patient received inappropriate Anti-Tachycardia Pacing therapy and a shocks for an episode detected in the Ventricular Tachycardia (VT) zone that was suspected to be Supra Ventricular Tachycardia (SVT). In addition, the Right Ventricular(RV) lead exhibited T-Wave Oversensing (TWOS) post ventricular pace. The Implantable Cardioverter Defibrillator (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 50070984 ↗
• MalfunctionApr 29, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT DURING USE OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THE DEVICE BATTERY WAS NOTED AS CRITICALLY LOW AFTER MULTIPLE SHOCKS ADMINISTERED BY THE ICD. THE ICD WAS SUBSEQUENTLY 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 25027730 ↗
• MalfunctionNov 14, 2025Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED POSSIBLE ANTI-TACHYCARDIA PACING (ATP) THERAPY FOR A DETECTED FAST VENTRICULAR TACHYCARDIA (FVT) EPISODE THAT WAS A SUSPECTED SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODE. 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 23555384 ↗
• InjuryApr 3, 2025Pacing 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) POSSIBLY DELIVERED INAPPROPRIATE SHOCKS AND ANTI-TACHYCARDIA PACING (ATP) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT). THE ICD DETECTED THE EPISODE 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 21769805 ↗
• InjuryFeb 5, 2025Defibrillation/Stimulation Problem; Device Sensing Problem; Defibrillation/Stimulation Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PALPITATIONS. IT WAS FURTHER REPORTED THAT THERAPY WAS INAPPROPRIATELY WITHHELD FOR AN EPISODE OF VENTRICULAR FIBRILLATION (VF) WHICH RESULTED IN A DELAY OF THERAPY. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED THE VF EPISODE AS SUPRA VENTRICULAR TACHYCARDIA (SVT). THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia; Ventricular Fibrillation

  MAUDE report 21312559 ↗
• InjuryNov 18, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) FOR SHORTNESS OF BREATH, DIZZINESS, AND COMPLAINED OF A LOW HEART RATE BELOW 40 BEATS PER MINUTE (BPM). REVIEW OF THE REMOTE TRANSMISSION SHOWED 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: Bradycardia; Dizziness; Dyspnea; Shock from Patient Lead(s)

  MAUDE report 20708707 ↗
• InjuryOct 30, 2024Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF BEING LIGHTHEADED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD POSSIBLY INAP PROPRIATELY WITHHELD THERAPY DURING A FAST VENTRICULAR TACHYCARDIA (FVT) EPISODE THAT WAS CLASSIFIED AS SUPRA VENTRICULAR TACHYCARDIA (SVT). THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; Tachycardia

  MAUDE report 20567647 ↗
• InjuryJun 7, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED DUE TO PALPITATIONS. UPON DEVICE INTERROGATION, IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POSSIBLY DELIVERED AN INAPPROPRIATE SHOCK AND ANTI-TACHYCARDIA PACING (ATP) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) WHEN THE DEVICE DETECTED THE EPISODE AS VENTRICULAR FIBRILLATION (VF). THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia; Shock from Patient Lead(s)

  MAUDE report 19484832 ↗
• InjuryApr 25, 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) DETECTED VENTRICULAR TACHYCARDIA (VT) DELIVERED ANTI-TACHYCARDIA PACING (ATP) AND SHOCKED THE PATIENT. IT WAS SUSPECTED THAT THE RHYTHM WAS SUPRA VENTRICULAR TACHYCARDIA (SVT) OR SINUS TACHYCARDIA, THEREFORE THE THERAPY WAS INAPPROPATE. ADDITIONALLY, IT WAS NOTED THAT THERE WAS NOISE ON THE RIGHT VENTRICULAR (RV) LEAD DURING ACTIVITY. 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 19182376 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED AFTER A TOOTH EXTRACTION WITH INFECTION AND SEPTIC BACTEREMIA WITH COLONIES GROWING ON THE RIGHT VENTRICULAR (RV) LEAD. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RV LEAD WERE REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 19168926 ↗
• InjuryApr 4, 2024Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED A SHOCK FOR A DETECTED VENTRICULAR FIBRILLATION (VF) EPISODE THAT WAS POSSIBLE SUPRA VENTRICULAR TACHYCARDIA (SVT) WITH A HIGH RATE. 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 19047839 ↗
• InjuryMar 12, 2024Adverse 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 AND REPLACED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia

  MAUDE report 18885456 ↗
• InjuryJan 25, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT RECEIVED MEDICATION CHANGES.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 18580834 ↗
• InjuryDec 20, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT WAS INAPPROPRIATELY SHOCKED BY THE RIGHT VENTRICULAR (RV) LEAD DUE TO T-WAVE OVERSENSING (TWOS). THE RV LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR HIGH RATE NON-SUSTAINED (HR-NS) AND SENSING INTEGRITY COUNTER (SIC) EPISODES. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE INAPPROPRIATE SHOCKS WERE DUE TO BOTH TWOS AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTING ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE AS VENTRICULAR FIBRILLATION (VF). REPROGRAMMING WAS COMPLETED. THE ICD REMAINS IN USE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 18365507 ↗
• InjuryDec 5, 2023Failure 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 THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD PROVIDED  INAPPROPRIATELY THERAPY FOR THE TREATED EPISODES OF THE VENTRICULAR TACHYCARDIA (VT) AFTER THERE WAS NO MORPHOLOGY CHANGE POST THE SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODE.  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 18267691 ↗
• InjuryOct 16, 2023Failure 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 THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EITHER DETECTED SUPRA VENTRICULAR TACHYCARDIA (SVT) AS VENTRICULAR TACHYCARDIA (VT) AND INAPPROPRIATELY SHOCKED THE PATIENT, OR THE ICD DETECTED VENTRICULAR TACHYCARDIA (VT) AS SUPRA VENTRICULAR TACHYCARDIA (SVT) AND INAPPROPRIATELY WITHHELD THERAPY. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Shock from Patient Lead(s)

  MAUDE report 17939216 ↗
• InjuryJul 19, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS DETECTED AS FASCICULAR VENTRICULAR TACHYCARDIA (FVT). 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 17356675 ↗
• InjuryJun 28, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED "INAPPROPRIATE" THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) IN THE FAST VENTRICULAR TACHYCARDIA (FVT) ZONE. THE WAVELET DISCRIMINATOR HAD BEEN WITHHOLDING THERAPY UNTIL HIGH RATE TIMEOUT WAS REACHED. 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 17216725 ↗
• InjuryJun 12, 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) SYSTEM WAS REMOVED AS THE PATIENT HAD A METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS INFECTION AND VEGETATION WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD DURING A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE PATIENT WAS TREATED WITH ANTIBIOTICS NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 17106326 ↗
• InjuryJun 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD BACTEREMIA FOUND IN A TISSUE CULTURE, AND STAPHYLOCOCCUS AUREUS IN THEIR BLOOD. ANTIBIOTICS WERE ADMINISTERED AND 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 17087188 ↗
• InjuryMay 23, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED SEVERAL SHOCKS FOR EPISODES OF VENTRICULAR FIBRILLATION (VF). AFTER REVIEW OF A REMOTE MONITORING TRANSMISSION, THE TREATED RHYTHM 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); Tachycardia

  MAUDE report 16985122 ↗
• InjuryApr 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) WITH SIGNS OF INFECTION. CULTURES WERE TAKEN AND TESTED POSITIVE FOR STAPHYLOCOCCUS AUREUS AND THE SOURCE OF THE INFECTION WAS UNKNOWN. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THE DEVICE SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 16825603 ↗
• InjuryMar 28, 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) SYSTEM WAS EXPLANTED DUE TO VEGETATION FOUND ON THE RIGHT VENTRICULAR (RV) LEAD DURING AN ECHOCARDIOGRAM. IT WAS ALSO NOTED THAT THE PATIENT HAD ENDOCARDITIS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis; Unspecified Infection

  MAUDE report 16628335 ↗
• InjuryFeb 28, 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) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. A NEW ICD SYSTEM WAS IMPLANTED ON THE RIGHT SIDE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 16451144 ↗
• InjuryOct 17, 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 15615125 ↗