Visia AF MRI™ VR SureScan™ DVFB1D1 (UDI 00763000059576)Recalls & reported problems

Summary

The FDA's MAUDE database contains 135 adverse event reports that list this exact device (DI 00763000059576), received between Jan 3, 2019 and Sep 5, 2026 — classified as 1 death, 92 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (45 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-1803-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 135 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50625499 ↗
• InjurySep 1, 2026Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  It was reported that during use of the Implantable Cardioverter Defibrillator (ICD) it was discovered that oversensing on the ventri cular lead in non-physiologic intervals/Electromagnetic Interference (EMI) occurred that resulted in inappropriate shock. The allied healthcare professional reported that patient received the inappropriate shock while having cauterization on the arm. The ICD rema ins in use. No further patient complications have been reported as a result of this event.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50547379 ↗
• InjuryAug 19, 2026Pacing 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 episodes 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 50333167 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE R LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) AND EXHIBITED IMPEDANCE REFLECTING A POSSIBLE FRACTURE; THEREFORE, THE RV LEAD WAS CAPPED. THE ICD WAS EXPLANTED AS THE PATIENT NO LONGER WANTED IT IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24676624 ↗
• InjuryFeb 25, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCKS FOR AN EPISODE OF ATRIAL T ACHYCARDIA/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 24444177 ↗
• InjuryJan 21, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE HIGH VOLTAGE THERAPY FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR ATRIAL FIBRILLATION (AF) WITH VARIABLE V-V INTERVALS 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 24136381 ↗
• InjuryJan 21, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED HIGH VOLTAGE THERAPY FROM THE SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR POSSIBLE ATRIAL ARRHYTHMIA THAT WAS DETECTED AS VENTRICULAR FIBRILLATION (VF). 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 24132979 ↗
• InjuryJan 8, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) EPICARDIAL PACING LEAD EXHIBITED AN ABRUPT INCREASE IN IMPEDANCE. THE RV DEFIBRILLATION COIL LEAD EXHIBITED VARIABLE IMPEDANCE WITH A HIGH UNDEFINED MEASUREMENT NOTED. IT WAS FURTHER REPORTED THAT BOTH LEADS WERE CAPPED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO A POTENTIAL PRODUCT PERFORMANCE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24005316 ↗
• MalfunctionNov 12, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS NOT WORKING CORRECTLY AS THE PATIENT HEART RATE WAS GOING DOWN TO THE RANGE OF 20 TO 30 BEATS PER MINUTE WHICH WAS BELOW THE PROGRAMMED RATE LIMIT. THE PATIENT EXPERIENCE BRADYCARDIA, WEAKNESS, DIZZINESS AND ALTERED MENTAL STATUS. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Altered State of Consciousness; Bradycardia; Dizziness; Muscle Weakness/Atrophy

  MAUDE report 23537416 ↗
• InjurySep 18, 2025Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SUPRA VENTRICULAR TACHYCARDIA (SVT) DISCRIMINATOR POSSIBLY DELAYED DETECTION AND ANTI-TACHYCARDIA PACING (ATP) THERAPY FOR VENTRICULAR FIBRILLATION (VF). IT WAS ALSO NOTED THERE WAS UNDERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. THE DEVICE AND LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Ventricular Fibrillation

  MAUDE report 23083464 ↗
• InjurySep 10, 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 23018164 ↗
• InjuryAug 28, 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 22913107 ↗
• MalfunctionJul 18, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEY WERE "OUT AND ABOUT" AND IT WAS HOT WHEN THEIR HEART RATE STARTED TO CLIMB. THE PATIENT NOTED THE DEVICE "NEVER KICKED IN TO BRING IT BACK DOWN." THE PATIENT NOTED BEING ANXIOUS AND DID NOT SLEEP WELL LAST NIGHT BECAUSE THEY WANTED THEIR DEVICE CHECKED TO SEE IF IT WAS WORKING PROPERLY. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Anxiety; Sleep Dysfunction

  MAUDE report 22543102 ↗
• InjuryJul 3, 2025Adverse 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 AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Drug Resistant Bacterial Infection; Endocarditis; Medical device site infection; Unspecified Infection

  MAUDE report 22396866 ↗
• InjuryJun 13, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS DETECTED AS VENTRICULAR FIBRILLATION (VF). IN ADDITION, THERE WAS VENTRICULAR UNDERSENSING. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (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 22202688 ↗
• MalfunctionMay 9, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED BY THE PATIENT'S HOME HEALTH PROVIDER THAT THE PATIENT'S HEART RATE WAS IN THE 30S AND 40S. IT WAS NOTED THAT THE PATIENT HAD BEEN REPORTING NUMEROUS SYMPTOMS OVER TIME AND HAS MANY MEDICAL ISSUES. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Insufficient Information

  MAUDE report 21995882 ↗
• InjuryApr 24, 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) DELIVERED ANTI-TACHYCARDIA PACING (ATP) AND A SHOCK FOR A DETECTED VENTRICULAR FIBRILLATION (VF) EPISODE THAT WAS POSSIBLE 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 21901910 ↗
• MalfunctionApr 21, 2025Electromagnetic Interference; Over-Sensing; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED EXTERNAL ELECTROMAGNETIC INTERFERENCE AND TRIGGERED LEAD INTEGRITY ALERT (LIA) FOR HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). THE DEVICE 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 21876505 ↗
• InjuryApr 3, 2025Failure to Deliver Shock/Stimulation; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD INAPPROPRIATELY DELIVERED THERAPY DURING EPISODES OF VENTRICULAR FIBRILLATION (VF) THAT WERE DETECTED AS A SUPRA VENTRICULAR TACHYCARDIA (SVT). IN ADDITION, THERE WAS POSSIBLE RIGHT VENTRICULAR OVER-SENSING FOLLOWING THE SHOCK, THAT DID NOT APPEAR TO AFFECT DEVICE FUNCTION. THE ICD AND RIGHT VENTRICULAR (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); Ventricular Fibrillation

  MAUDE report 21761746 ↗
• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 21753365 ↗
• InjuryMar 27, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE PATIENT THAT THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) "HAS A DEFECTIVE COMPONENT" AND THAT THE DEVICE WAS REPROGRAMMED. 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 21707124 ↗
• InjuryMar 18, 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 A SHOCK AND ANTI-TACHYCARDIA PACING (ATP) FOR RAPID VENTRICULAR RESPONSE (RVR). THE ICD DETECTED THE EPISODE AS VENTRICULAR TACHYCARDIA (VT). IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. 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 21638593 ↗
• InjuryJan 27, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED AN INAPPROPRIATE SHOCK FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE DETECTED AS VENTRICULAR FIBRILLATION (VF) DUE TO A FEATURE THAT ALLOWS THE DEVICE TO OVERRIDE SUPRA VENTRICULAR TACHYCARDIA (SVT) DISCRIMINATION AND DELIVER THERAPY FOR A TACHYARRHYTHMIA THAT CONTINUES BEYOND A PROGRAMMED LENGTH OF TIME. IN ADDITION, IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING OF NON-PHYSIOLOGIC NOISE AND SENSING INTEGRITY COUNTER (SIC). 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 21248372 ↗
• InjuryJan 15, 2025Adverse 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 A POCKET INFECTION. NO FUR THER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21158694 ↗
• InjuryNov 26, 2024Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DURING A PROCEDURE WHERE CAUTERY WAS USED. A LEAD INTEGRITY ALERT (LIA) TRIGGERED DUE TO HIGH RATE NON-SUSTAINED (HRNS) EPISODES AND SENSING INTEGRITY COUNTER (SIC). REVIEW OF THE EPISODE SHOWS NON-PHYSIOLOGIC MORPHOLOGIES, WHICH WERE RELATED TO THE CAUTERY. 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 20786487 ↗