Visia AF MRI™ VR SureScan™ DVFB1D4 (UDI 00643169566422)Recalls & reported problems

Summary

The FDA's MAUDE database contains 453 adverse event reports that list this exact device (DI 00643169566422), received between Dec 9, 2016 and Sep 25, 2026 — classified as 10 deaths, 355 injuries, 88 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (133 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 453 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Premature Discharge of Battery

  It was reported that the Implantable Cardioverter Defibrillator (ICD) unexpectedly reached Recommended Replacement Time (RRT). The patient reportedly experienced "odd symptoms" which the physician noted may or may not be related to the device. The device was explanted and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Insufficient Information

  MAUDE report 50898433 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) system was explanted due to an infection in the blood. The patient experienced a fever. No further patient complications have been reported as a result of this event.

  Patient problems: Fever; Sepsis; Unspecified Infection

  MAUDE report 50696080 ↗
• InjurySep 3, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50596617 ↗
• InjuryJul 29, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the patient presented to a local rural Emergency Room (ER) due to alert tones. It was further reported that the Right Ventricular (RV) lead had a suspected fracture in the low voltage portion and Out of Range (OOR) high pacing impedance, oversensing, and Non-Physiologic/Sensing Integrity Counter (SIC). It was further reported that the patient had been admitted into the hospital, a Wearable Cardioverter Defibrillator (WCD) was placed, and reprogramming was done. Several days later, the lead extraction was abandoned due to laser lead extraction equipment issues. It was further reported that the device had an unknown product issue. The lead was cut, capped and remains in the patient, while the device was explanted. The patient was referred to a different location for lead extraction.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50073180 ↗
• InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Bacteremia

  MAUDE report 25429903 ↗
• MalfunctionJun 2, 2026Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) 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 25365151 ↗
• InjuryMay 8, 2026Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THERE WAS OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD IN NON-PHYSIOLOGIC INTERVALS AND ELECTROMAGNETIC INTERFERENCE (EMI). A LEAD INTEGRITY ALERT (LIA) TRIGGERED DUE TO HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). IT WAS NOTED THAT THE PATIENT HAD BREAST SURGERY DURING WHICH HIGH VOLTAGE THERAPY WAS DELIVERED. A MAGNET WAS PLACED ON TOP OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DURING SURGERY, BUT IT SLIPPED AWAY FROM THE SITE. IT WAS NOTED THAT THE LIA COULD NOT BE RULED OUT. THE RV LEAD AND ICD 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 25131489 ↗
• InjuryMar 19, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLY INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND HIGH-VOLTAGE THERAPY FOR ATRIAL F IBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE/SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CLASSIFIED 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 24640724 ↗
• MalfunctionMar 13, 2026Battery Problem

  AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE TO REACHING THE RECOMMENDED REPLACEMENT TIME (RRT) WITH NO COMPLAINT INFORMATION. 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 24594160 ↗
• InjuryMar 11, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POTENTIAL INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND A SHOCK FOR AN EPISODE OF SUPRA VENTRICULAR TACHYCARDIA (SVT) DETECTED AS VENTRICULAR FIBRILLATION (VF). 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 24573133 ↗
• MalfunctionMar 6, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT TELEMETRY COULD NOT BE ESTABLISHED WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). 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 24537168 ↗
• InjuryMar 3, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE ICD WAS EXPLANTED.

  Patient problems: Burning Sensation; Skin Burning Sensation

  MAUDE report 24497442 ↗
• InjuryJan 30, 2026Premature Discharge of Battery; Failure to Interrogate; Reset Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL EXPERIENCING CARDIAC ARREST, PNEUMONIA, LACTIC ACIDOSIS AND CARDIOGENIC SHOCK. IN ADDITION, THE PATIENT WAS IN VENTRICULAR FIBRILLATION (VF) FOR APPROXIMATELY 40 MINUTES AND WAS UNRESPONSIVE. CARDIOPULMONARY RESUSCITATION (CPR) WAS ADMINISTERED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD POTENTIALLY REACHED RECOMMENDED REPLACEMENT TIME (RRT) STATUS UNEXPECTEDLY. THERE WAS SUSPECTED PREMATURE BATTERY DEPLETION, AND TWO ELECTRICAL RESETS OCCURRED. TELEMETRY WAS NO LONGER ABLE TO BE ESTABLISHED. A LEAD IMPEDANCE WARNING TRIGGERED DUE TO UNDEFINED HIGH RV DEFIBRILLATOR COIL IMPEDANCE. THE DEVICE AND LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Arrest; Cardiogenic Shock; Pneumonia; Syncope/Fainting; Ventricular Fibrillation

  MAUDE report 24225430 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION IDENTIFIED AS METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) SYSTEMIC 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: Drug Resistant Bacterial Infection; Unspecified Infection

  MAUDE report 24203152 ↗
• MalfunctionJan 20, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE HEALTHCARE PROFESSIONAL DIDN'T KNOW THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS WORKING AT ALL THOUGH NO SPECIFIC CONCERN WAS STATED. IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A DECLINE IN PACING AND DEFIBRILLATION COIL IMPEDANCE AS WELL AS R-WAVE AMPLITUDE. THE ICD AND RV LEAD 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 24114322 ↗
• InjuryJan 8, 2026Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FEATURE DESIGNED TO WITHHOLD INAPPROPRIATE VENTRICULAR DETECTION IF THE RHYTHM DISPLAYS CHARACTERISTICS OF A SUPRA VENTRICULAR TACHYCARDIA (SVT) ORIGIN INAPPROPRIATELY WITHHELD THERAPY. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24002216 ↗
• InjuryJan 6, 2026Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THERE WAS OVERSENSING AND A LEAD INTEGRITY ALERT (LIA) DUE TO HIGH RATE NON-SUSTAINED EPISODES AND SHORT VENTRICULAR INTERVALS CAUSED BY ELECTROMAGNETIC INTERFERENCE. THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). IT WAS NOTED THE PATIENT WAS IN A PROCEDURE AT THE TIME WHERE A MAGNET WAS NOT USED. 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 23976746 ↗
• InjuryJan 6, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THERE WAS PREMATURE BATTERY DEPLETION ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). 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 23974789 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DEVICE POCKET INFECTION WITH VEGETATION NOTED ON THE DISTAL PORTION OF THE RIGHT VENTRICULAR (RV) LEAD. THE ORGANISM RESPONSIBLE FOR THE INFECTION WAS NOTED TO BE METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS. 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; Medical device site infection

  MAUDE report 23853733 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT ICD SYSTEM WAS EXPLANTED DUE TO A SUSPECTED INFECTION.

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

  MAUDE report 23817457 ↗
• MalfunctionNov 26, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A DROP BATTERY LONGEVITY FROM 2.4 YEARS TO 1.8 YEARS IN THE TIME SPAN OF FOUR MONTHS. 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 23660527 ↗
• InjuryNov 21, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED BY THE PATIENT THAT THEY HAD BEEN IN THE INTENSIVE CARE UNIT (ICU) FOR TWO WEEKS BECAUSE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD SHOCKED THEM OVER FIFTY TIMES. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23615582 ↗
• MalfunctionNov 13, 2025Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED VENTRICULAR OVERSENSING AND NOISE RELATED TO ELECTROMAGNETIC INTERFERENCE. THE EPISODES CORRESPOND TO THE SAME DATE AS SURGICAL PROCEDURES FOR THE PATIENT. 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 23547521 ↗
• InjuryOct 24, 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 SUSPECTED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS DETECTED AS VENTRICULAR TACHYCARDIA (VT). 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 23380845 ↗
• MalfunctionOct 16, 2025Battery Problem: High Impedance; Battery Problem: High Impedance

  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 23316110 ↗