Visia AF™ VR DVAB1D1 (UDI 00643169566347)Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 00643169566347), received between Dec 9, 2016 and Aug 26, 2026 — classified as 2 deaths, 64 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (17 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 16, 2026.

Recalls naming this device

1. Feb 3, 2021Open, 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, 2017Terminated

   Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).

   Z-0589-2018 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 87 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2026Premature Discharge of Battery

  It was reported that the Implantable Cardioverter Defibrillator (ICD) exhibited premature battery depletion. The device 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 50457474 ↗
• MalfunctionSep 4, 2025Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS DETECTED AS VENTRICULAR TACHYCARDIA (VT). 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 22969544 ↗
• 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 22946749 ↗
• 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 22946298 ↗
• 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 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 22939024 ↗
• 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 22937509 ↗
• 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 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 22937409 ↗
• 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 ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR) DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE. THE DATA ALSO SHOWED RIGHT VENTRICULAR (RV) LEAD NOISE HAD IMPACTED EPISODE DISCRIMINATION. 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 22913128 ↗
• InjuryAug 26, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE DEVICE EXHIBITED PREMATURE BATTERY DEPLETION. THE DEVICE 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 22895128 ↗
• MalfunctionAug 12, 2025Battery Problem; Communication or Transmission Problem; Battery Problem; Communication or Transmission Problem

  THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22784855 ↗
• InjuryJul 17, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE REACHED RECOMMENDED REPLACEMENT TIME (RRT) DUE TO SUSPECTED PREMATURE BATTERY DEPLETION. THE DEVICE 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 22532819 ↗
• InjuryApr 28, 2025Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DIZZINESS AND CHEST PAIN. THE PHYSICIAN REPORTED THAT THE PATIENT WAS EXTERNALLY SHOCKED FOR SUSTAINED VENTRICULAR TACHYCARDIA (VT). IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DID NOT DETECT SUSTAINED VT/VENTRICULAR FIBRILLATION (VF) AND CLASSIFIED THE 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: Chest Pain; Dizziness; Tachycardia

  MAUDE report 21921216 ↗
• InjuryNov 20, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED, THAT THE PATIENT WAS EXPERIENCING BRADYCARDIA. SO, AN RIGHT ATRIAL (RA) LEAD WAS ADDED TO PROVIDE ADDITIONAL PACING SUPPORT. AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED, AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 20736824 ↗
• InjuryJul 26, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED DUE TO PREMATURE BATTERY DEPLETION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19843382 ↗
• MalfunctionJul 12, 2024Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS DETECTED AS FAST VE NTRICULAR TACHYCARDIA (FVT). THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (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 19733909 ↗
• InjuryJun 7, 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 DUE TO ENDOCARDITIS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis

  MAUDE report 19486943 ↗
• InjuryMay 3, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE  IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) BATTERY EXHIBITED PREMATURE BATTERY DEPLETION . 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 19241734 ↗
• MalfunctionApr 24, 2024Failure to Interrogate; Pacing Problem; Failure to Interrogate; Pacing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS UNABLE TO BE INTERROGATED WITH DIFFERENT TYPES OF PROGRAMMERS, AND NO TONE WAS EMITTED FROM THE DEVICE WHEN A MAGNET WAS PLACED OVER IT. IT WAS NOTED THAT THE MOST RECENT TRANSMISSION FROM TWO YEARS PRIOR HAD SHOWED NORMAL DEVICE FUNCTION WITH AN ESTIMATED EIGHT YEARS OF DEVICE LONGEVITY REMAINING. 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 19173077 ↗
• InjuryApr 5, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD PREMATURE BATTERY DEPLETION. SHORTENED RECOMMENDED REPLACEMENT TIME (RRT) TO END OF SERVICE (EOS) IS SUSPECTED. 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 19052955 ↗
• InjuryMar 27, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT REVIEW OF A REMOTE TRANSMISSION SHOWED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED THE RECOMMENDED REPLACEMENT TIME (RRT) INDICATOR AND END OF SERVICE (EOS) INDICATORS WHEN THE ESTIMATED REMAINING LONGEVITY WAS THREE YEARS APPROXIMATELY FOUR MONTHS PRIOR. REVIEW OF HISTORICAL DATA FROM THE DEVICE SHOWED AN UNEXPLAINED RAPID DECLINE IN THE REMAINING EXPECTED LONGEVITY WITH NO ASSOCIATED CHANGES IN DEVICE ACTIVITY THAT WOULD CONTRIBUTE TO THE DROP, AND PREMATURE BATTERY DEPLETION IS SUSPECTED. 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 18988666 ↗
• InjuryJan 17, 2024Defibrillation/Stimulation Problem; Low impedance; Impedance Problem; Defibrillation/Stimulation Problem; Low impedance; Impedance Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED SHORT CIRCUIT PROTECTION DURING HIGH VOLTAGE THERAPY RESULTING IN LESS THAN THE PROGRAMMED HIGH VOLTAGE ENERGY BEING DELIVERED FOR A VENTRICULAR FIBRILLATION (VF) EPISODE. A TOTAL OF THREE SHOCKS WERE DELIVERED, TWO OF WHICH HAD REDUCED ENERGY. THE THIRD SHOCK DELIVERED WAS A FULL ENERGY SHOCK AND TERMINATED THE ARRHYTHMIA. FOLLOWING THE HIGH VOLTAGE THERAPY DELIVERIES THERE WAS A DROP IN RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE RESULTING IN A LOW OUT OF RANGE (OOR) BIPOLAR AND RV TIP TO RV COIL IMPEDANCE ALERTS. THE PATIENT WAS ADMITTED TO HOSPITAL AND THE ICD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Ventricular Fibrillation

  MAUDE report 18530530 ↗
• InjuryDec 1, 2023Adverse 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 EXPLANTED DUE TO SUSPECTED INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18247073 ↗
• InjuryNov 16, 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 DUE TO THE PATIENT EXPERIENCING A SYSTEMIC INFECTION. IT WAS NOTED THAT NO DEVICE OR LEAD PERFORMANCE ISSUES WERE OBSERVED AT THE TIME. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18147902 ↗
• InjuryNov 15, 2023Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS FURTHER REPORTED THAT THE ICD¿S (IMPLANTABLE CARDIOVERTER DEFIBRILLATOR) DISCREPANCY IN LONGEVITY HAD OCCURRED BETWEEN JULY AND DECEMBER 2023. THE CLINIC STATED THEY WILL HAVE FREQUENT BATTERY CHECKS EVERY TWO WEEKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18141756 ↗
• InjurySep 27, 2023Defibrillation/Stimulation Problem; Low impedance; Communication or Transmission Problem; Impedance Problem; Inappropriate or Unexpected Reset; Reset Problem; Defibrillation/Stimulation Problem; Low impedance; Communication or Transmission Problem; Impedance Problem; Inappropriate or Unexpected Reset; Reset Problem

  IT WAS FURTHER REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED PRIOR TO REPLACEMENT AND THAT THE POWER ON RESETS (POR) WERE PARTIAL PORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17827671 ↗