Visia AF MRI™ VR SureScan™ DVFB1D1 (UDI 00643169717213)Recalls & reported problems

Summary

The FDA's MAUDE database contains 106 adverse event reports that list this exact device (DI 00643169717213), received between Apr 6, 2017 and Sep 28, 2026 — classified as 1 death, 79 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (44 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 25 most recent of 106 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient received several inappropriate shocks from the Implantable Cardioverter Defibrillator (ICD) during a spinal cord stimulator surgery prior to magnet application. It was also observed that a Lead Integrity Alert (LIA) was triggered during the surgery. 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 50918884 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) and Right Ventricular (RV) lead were explanted. The reason for explant was not reported. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 50058295 ↗
• MalfunctionMar 13, 2026Battery Problem

  AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED FOR A SYSTEM UPGRADE WITH A D UAL-CHAMBER DEVICE. DURING THE MANUFACTURER¿S PRELIMINARY ANALYSIS, THE DEVICE DID NOT MEET LONGEVITY EXPECTATIONS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24589841 ↗
• InjuryFeb 5, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED RAPID BATTERY DEPLETION. THE DEVICE WAS EXPLANTED WITH REPLACEMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24273282 ↗
• InjuryJan 15, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT THE THERAPY WAS CONFIRMED TO BE INAPPROPRIATE FOR SVT OR ATRIAL FLUTTER (AFL). THE ICD WAS REPROGRAMMED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24086595 ↗
• MalfunctionNov 20, 2025Battery Problem; Battery Problem

  THE DEVICE WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE TO REACHING ELECTIVE REPLACEMENT INDICATOR (ERI) AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23609416 ↗
• InjuryOct 17, 2025Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT DURING A CRANIOTOMY PROCEDURE THE PATIENT WAS SHOCKED DURING THE PROCEDURE DUE TO OVERSENSING. IT WAS NOTED THAT A MAGNET WAS APPLIED AND WAS MOVING INTO AND OUT OF THE FIELD OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). SUBSEQUENTLY, AS A RESULT, THE RV LEAD INTEGRITY ALERT (LIA) TRIGGERED DUE TO HIGH RATE NON-SUSTAINED VENTRICULAR TACHYCARDIA (VT) AND SENSING INTEGRITY COUNTER (SIC)/OVERSENSING. 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 23326853 ↗
• MalfunctionSep 5, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PREMATURE 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 22978821 ↗
• InjurySep 3, 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 22952275 ↗
• 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 FIBRILLATION (VF) 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 22939907 ↗
• InjurySep 2, 2025Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation; Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED VIA INTERNAL REVIEW OF HISTORICAL DEVICE DATA TRANSMITTED FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THAT INAPPROPRIATE HIGH-VOLTAGE THERAPY WAS DELIVERED DUE TO ELECTROMAGNETIC INTERFERENCE (EMI). 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 22939562 ↗
• 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 FIBRILLATION (VF) 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 22939250 ↗
• 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 FIBRILLATION (VF) 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 22938988 ↗
• 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 FIBRILLATION (VF) 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 22938869 ↗
• 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 22916126 ↗
• 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 FIBRILLATION (VF) 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 22916041 ↗
• 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 22913259 ↗
• 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 22913118 ↗
• InjuryAug 25, 2025Signal Artifact/Noise; Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED VIA INTERNAL REVIEW OF HISTORICAL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DATA TRANSMITTED FROM THE DEVICE THAT INAPPROPRIATE HIGH-VOLTAGE THERAPY WAS DELIVERED FOR AN EPISODE DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE DUE TO NOISE ON THE RIGHT VENTRICULAR (RV) LEAD CHANNEL. THE SOURCE OF THE NOISE WAS UNCLEAR, BUT DUE TO THE REGULARITY OF OCCURRENCE, IT MAY HAVE BEEN DUE TO ELECTROMAGNETIC INTERFERENCE (EMI). 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 22883729 ↗
• MalfunctionJun 9, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INAPPROPRIATELY DETECTED ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES DUE TO THE PATIENT'S CONSISTENTLY IRREGULAR R-R INTERVAL. 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 22171384 ↗
• MalfunctionMar 31, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI)/RECOMMENDED REPLACEMENT TIME (RRT) AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21731405 ↗
• InjuryMar 20, 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 ANTI-TACHYCARDIA PACING (ATP) AND A SHOCK FOR A RHYTHM DETECTED AS VENTRICULAR FIBRILLATION (VF) WHICH WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT). THERAPIES WERE INITIALLY WITHHELD BY MORPHOLOGY DISCRIMINATOR MATCHING SVT, BUT THERAPIES WERE DELIVERED DUE TO HIGH-RATE TIMEOUT. 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 21653701 ↗
• InjuryJan 17, 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) POSSIBLY DELIVERED INAPPROPRIATE SHOCKS AND ANTI-TACHYCARDIA PACING (ATP) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) OR INAPPROPRIATELY WITHHELD THERAPY FOR VENTRICULAR TACHYCARDIA (VT) BY CLASSIFYING THE EPISODE AS 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 21182204 ↗
• InjuryJan 2, 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 THAT WAS DETECTED AS VENTRICULAR FIBRILLATION (VF). FOLLOWING THE SHOCK, THE PATIENT'S RHYTHM MORPHOLOGY CHANGED. THE PATIENT WAS LATER TREATED AT THE EMERGENCY ROOM WITH AN EXTERNAL SYNCHRONIZED CARDIOVERSION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Heart Failure/Congestive Heart Failure; Shock from Patient Lead(s)

  MAUDE report 21057015 ↗
• InjuryDec 10, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED AN UNEXPLAINED RAPID BATTERY VOLTAGE DEPLETION AND TRIGGERED AN UNEXPECTED RECOMMENDED REPLACEMENT TIME (RRT). IT WAS NOTED THAT THE BATTERY VOLTAGE DID NOT RECOVER AFTER A CONDITIONING CHARGE. APPROXIMATELY 6 DAYS LATER, 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 20896042 ↗